Cancer Clinical Trials Open in Western Australia

Transcription

1 Cancer Clinical Trials Open in Western Australia Last Updated: 4 August 2015

2 A list of cancer clinical trials open in Western Australia that aim to improve the treatment and care of people with cancer. Contents Disclaimer... 5 Bladder and Renal... 6 CHECKMATE 214 (BMS CA ) Renal study... 6 WO29637 Study... 7 Bone, soft tissue and other sarcomas... 8 Denosumab study... 8 Brain... 9 CATNON... 9 TROG Trial (WBRT Mel) Breast Abbvie M Trial Abbvie M (BRIGHTNESS) Trial AREA Study ASLAN Trial COLET Study IMIB Trial LORELEI Trial MONARCH 3 Trial Non-Randomised IORT Novartis CBYL719A Novartis CLEE011E MonaLeesa Novartis CBYL719X2107 (LEE2107) ROLLIS Randomised Controlled Trial SANDPIPER Study STARS (TROG 08.06) TnAcity Study Colorectal ALT GIST Study ASCOLT Study CHALLENGE Study ICE CREAM Study LUME-1 Study Gynaecological

3 ARIEL 2 Study ARIEL 3 Study CAELYX YONDELIS Study JIAE Lilly Ovarian Study Outback Study OVAR 2.21 Study Haematology Trials includes Leukaemia, Lymphoma, Myeloma Acute Myeloid Leukaemia AML M AML M QUAZAR Study Acute Lymphoblastic Leukaemia ALL6 Study TOWER (EC REG ) Study Chronic Lymphocytic Leukaemia MURANO GO28667 Trial Chronic Myeloid Leukaemia ENESTswift Trial The Australasian RESIST Study (CML10) Hodgkin s Lymphoma Millennium Study Non-Hodgkin s Lymphoma BGB-3111 Study C25001 Study GS-US Study (EC REG ) NHL24 Trial - Primary Central Nervous System Lymphoma Phoenix Study Multiple Myeloma There are currently no Multiple Myeloma trials available for listing Bone Marrow Transplant ALLG BM CTTWA Phase II MSC Trial Myelodysplasic Syndrome MDS BLAST Trial Other Haematology Trials C16011 Study KaloBios Trial MEPO Study

4 MM13 Trial MPN01 Registry PERSIST2 PAC326 Myelofibrosis Trial PNH Registry TIMES MRI Trial TTP Registry Head and Neck Eating As Treatment (EAT Trial) TROG Metastatic Head and Neck Squamous Cell Carcinoma Study Lung Cancer and Mesothelioma Lung Cancer AURA3 Study CA (Opening October 2015) CA (Opening October 2015) FLAURA-1 Study Mesothelioma COMMAND Study Phase 1 and Other Cancers IMRT Linear Advanced Solid Tumours Study (HMPL-504) Linear Advanced Solid Tumours Study PG Linear Advanced Solid Tumours and Lymphomas Study Linear HER-3 Positive Solid Tumours Study P3BEP Germ Cell Tumour Study Prostate CBCT - Image Guided Radiation Therapy ENZAMET Study IMAGE GUIDED RADIATION THERAPY ProCare Trial RAVES (TROG 08.03) SPARTAN Study Quality of Life, Survivorship and Lifestyle Exercise and Bone Metastatic Disease Study Exercise and High Grade Glioma Study Exercise and Prostate Cancer Study Finding My Way Improving sexual health in men with prostate cancer Preventing chemo-brain in breast cancer patients

5 Skin Cancer BMS CA Study BRF Study COLUMBUS Study EMR Merkel Cell Carcinoma Study Tin Foil Nose study TROG Merkel PET Phase II Protocol (MP3 Study) Upper Gastrointestinal, Pancreatic and Liver ABI-007-PANC-003 (CELGENE) Adjuvant Pancreatic Study ALT GIST Study HELOISE Study JACOB Study TOPGEAR (TROG 08.08) YOSEMITE Study Disclaimer This list of cancer clinical trials open in WA is by no means necessarily ALL clinical trials open in WA. This list is dependent upon the willingly provided by interested and participating hospital centres and clinicians. On a 3 monthly basis from the inception of the website in May the Cancer Council will undertake updates and reviews to maintain the accuracy of the listing of trials. The Cancer Council does not accept responsibility for any loss or damage occasioned by use of the contained on the trials listing nor from any access to it. All access and use is at the risk of the user. specific - particularly regarding an individual's personal eligibility for any potential trial should be discussed with ones treating clinician. 5

6 Bladder and Renal CHECKMATE 214 (BMS CA ) Renal study A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma. The purpose of this study is to compare the progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer. SCGH Medical Oncology Ph. (08) Cancer Centre Clinical Trials Unit Caroline Stone Clinical Trials Manager Phone Fax [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 6

7 WO29637 Study A Phase III, Open-Label, Randomized Study Of Mpdl3280a (Anti-Pd-L1 Antibody) In Combination With Bevacizumab Versus Sunitinib In Patients With Untreated Advanced Renal Cell Carcinoma. This randomized, open-label study is designed to evaluate the efficacy of MPDL3280A (anti-pd-l1 antibody) plus bevacizumab versus sunitinib in patients with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting. Tamsyn Whitcher Murdoch Oncology Clinical Trials Unit Ph. (08) [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 7

8 Bone, soft tissue and other sarcomas Denosumab study An Open-label, Multi-Centre, Phase 2 Study of Denosumab in Subjects with Giant Cell Tumour of Bone. To determine how safe Denosumab is in treating subjects with giant cell tumour of bone. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 8

9 Brain CATNON A randomised phase III Trial on concurrent and adjuvant Temozolomide chemotherapy in non 1p/19q deleted anaplastic glioma to evaluate overall survival. This study looks at the effectiveness of different combinations of treatment with oral Temozolomide chemotherapy and radiotherapy, in people with brain cancer of the type non 1p/19q deleted anaplastic glioma. Who is it for? You can join this study if you have brain cancer that has been newly diagnosed (anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma) and you are not missing chromosomes 1p/19q. Trial details Participants will be randomly divided into four groups which will receive treatment as follows: radiotherapy only radiotherapy and Temozolomide chemotherapy at the same time radiotherapy and Temozolomide chemotherapy four weeks later radiotherapy and Temozolomide chemotherapy at the same time and then Temozolamide chemotherapy again four weeks later. The study aims to assess whether: radiotherapy and Temozolomide chemotherapy at the same time improves overall survival rates when compared with radiotherapy alone Temozolamide chemotherapy given after radiotherapy improves overall survival when compared to no Temozolamide after radiotherapy. Currently different institutions adopt different strategies of radiation and chemotherapy for treating anaplastic glioma, as the most effective treatment is not known. However some studies suggest that there is an increase in progression free survival when chemotherapy is given after radiotherapy. Many glioma patients deteriorate at the time of progression. Thus prolonging the time to progression may help to keep patients in good clinical condition for longer and improve their quality of life. SCGH Medical Oncology Ph. (08) Australia New Zealand Clinical Trials Registry [ACTRN ] Acknowledgements: Australia New Zealand Clinical Trials Registry 9

10 TROG Trial (WBRT Mel) Whole Brain Radiotherapy following local treatment of intracranial metastases of melanoma A randomised phase III trial. The purpose of this study is to investigate the effect of adding whole brain radiotherapy after surgery and/or stereotactic irradiation (SI) on the development of further brain metastases (cancer spread to the brain) in participants with melanoma. People with brain metastases from melanoma are offered different treatment options after local treatment of their brain metastases via surgery or stereotactic irradiation. Depending on the treating institution and the clinician involved a patient may or may not be offered whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration. Participants will be randomised after local treatment of their brain metastases to either WBRT or observation. 200 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites. SCGH Radiation Oncology Ph. (08) Australia New Zealand Clinical Trials Registry [ACTRN ] Acknowledgements: Australia New Zealand Clinical Trials Registry 10

11 Breast Abbvie M Trial A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without the Poly ADP-ribose Polymerase (PARP) Inhibitor Veliparib (ABT-888) in Human Epidermal Growth Factor Receptor 2 (HER2)- Negative Metastatic or Locally Advanced Unresectable Breast Cancer Gene (BRCA)-Associated Breast Cancer. The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced, unresectable, BRCA-associated breast cancer. Breast Clinical Trials Unit Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 11

12 Abbvie M (BRIGHTNESS) Trial A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC). This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC. St John of God Ph. (08) Tamsyn Whitcher Murdoch Oncology Clinical Trials Unit Ph. (08) [email protected] Cancer Centre Clinical Trials Unit Caroline Stone Clinical Trials Manager Phone Fax [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 12

13 AREA Study Randomised study to evaluate the impact of Aerobic and Resistance Exercise on fatigue in patients with advanced breast cancer (AREA study). The study will assess the feasibility of a specified exercise program in patients with advanced breast cancer and its impact on improving fatigue. Who is it for? You may be eligible to join this study if you are a female with metastatic breast cancer aged between years, and are being managed at the Mount Hospital, Perth, WA. Eligible women will also have experienced subjective fatigue in the past several weeks as a persistent symptom. Study details This study will be conducted in two parts. In Part 1, eligible patients will be offered a 6 week exercise program, where the primary endpoint will be to assess feasibility and overall safety. If the program is deemed as being feasible and safe, Part 2 of the study will commence. In Part 2, participants will be randomly (by chance) allocated to one of two groups. Participants in one group will be offered the 6 week exercise program, whilst participants in the other group will not participate in the exercise program. On completion of the program, participants will be asked to complete some questionnaires to assess their levels of fatigue, depression and pain. They will also be asked to conduct a brief walking test to assess any changes in aerobic fitness. Breast Clinical Trials Unit Ph. (08) Australia New Zealand Clinical Trials Registry [ACTRN ] Acknowledgements: Australia New Zealand Clinical Trials Registry 13

14 ASLAN Trial A Randomized Phase 2A/2B, Multicenter Study to Compare the Efficacy and Safety of ASLAN001 in Combination with Capecitabine to Lapatinib in Combination with Capecitabine in Patients with HER-2-Positive Metastatic Breast Cancer that has Failed on Prior Trastuzumab Therapy. This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer that has failed on prior trastuzumab therapy. Breast Clinical Trials Unit Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 14

15 COLET Study A Multistage, Phase II Study Evaluating The Safety And Efficacy Of Cobimetinib In Combination With Paclitaxel As First-Line Treatment For Patients With Metastatic Triple-Negative Breast Cancer. This multistage, randomized, Phase II, double-blind, multicenter, placebocontrolled trial will evaluate the safety and tolerability and estimate the efficacy of cobimetinib + paclitaxel versus placebo + paclitaxel in patients with metastatic or locally advanced, triple-negative adenocarcinoma of the breast that have not received prior systemic therapy for metastatic breast cancer (MBC). An open-label safety run-in stage of the combination cobimetinib + paclitaxel will undergo an Internal Safety Review before starting the enrollment of patients into the expansion double-blind stage of this study. Patients may continue on study treatment until the development of progressive disease, unacceptable toxicity, and/or consent withdrawal. The target sample size is 12 patients for the safety run-in stage and approximately 100 patients in the expansion stage. Tamsyn Whitcher Murdoch Oncology Clinical Trials Unit Ph. (08) [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 15

16 IMIB Trial Establishing the prognostic importance of key immune suppressor cells and molecules in the primary tumour and regional nodes of patients with Luminal B breast cancer. Breast Cancer Research Centre Ph. (08)

17 LORELEI Trial A Phase II Randomized, Double-Blind, Parallel Cohort Study of Neoadjuvant Letrozole + GDC-0032 Versus Letrozole + Placebo in Post-Menopausal Women With ER+/HER2- Primary Breast Cancer. This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 versus letrozole and pl acebo in postmenopausal women with ER+/HER2- untreated, Stage I- III operable bre ast cancer. Patients will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 mg will be dosed once daily plus eit her GDC-0032 at 6 mg or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks. Cancer Centre Clinical Trials Unit Caroline Stone Clinical Trials Manager Phone Fax [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 17

18 MONARCH 3 Trial A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY , a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting. The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. Tamsyn Whitcher Murdoch Oncology Clinical Trials Unit Ph. (08) [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 18

19 Non-Randomised IORT Prospective Non-randomised Intrabeam Protocol. The main purpose of this study is to offer a once off dose of intraoperative radiotherapy to women with early breast cancer, who are either over the age of 70 or have a medical or social reason for not being able to have a 5-6- week course of standard external beam radiotherapy. Intraoperative radiotherapy is not yet a standard form of treatment (it is still experimental) because although early results suggest it is as good as standard treatment for a specific group of women, about the potential longer term effects of the treatment is not yet known. As a result, women can only have this treatment as part of a formal clinical trial. It has been clearly shown that in early low-risk breast cancer, removal of only the tumour and the lymph nodes under the armpit followed by post-operative radiotherapy is effective and has the benefit of preserving the breast. This type of treatment is called breast conserving therapy. Traditionally, radiotherapy is given daily for 5-6 weeks (Monday to Friday). Intra-operative Radiotherapy, a new form of radiation therapy, has now become available for patients suitable for breast conserving therapy. The new technique involves the delivery of radiation intra-operatively (during surgery) in a single procedure. The safety and feasibility of this new device has been tested internationally, and since this treatment is not yet considered standard therapy, this trial allows women to receive the treatment if found suitable by a Radiation Oncologist. SCGH Radiation Oncology Ph. (08)

20 Novartis CBYL719A2201 A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-positive HER2-negative Breast Cancer. The purpose of the study is to determine whether treatment with a PI3K inhibitor plus letrozole leads to an increase in pathologic response compared to treatment with placebo plus letrozole in patients with Breast cancer. The purpose of this study is to determine the treatment benefit and the safety profile of BKM120 (investigational treatment) or placebo (like a sugar pill) taken with fulvestrant in patients whose breast cancer is inoperable or has spread to other organs in the body. As it is not known if combining BKM120 and fulvestrant is better than fulvestrant alone, a comparison is required to find out which of these two treatments (fulvestrant plus BKM120 and fulvestrant plus placebo) give better results. Approximately 842 patients will be treated with ~ 30 patients enrolled in Australia. Breast Clinical Trials Unit Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 20

21 Novartis CLEE011E MonaLeesa-7 A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer. This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer. Breast Clinical Trials Unit Ph. (08) Tamsyn Whitcher Murdoch Oncology Clinical Trials Unit Ph. (08) [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 21

22 Novartis CBYL719X2107 (LEE2107) A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer. The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor). This is a multi-center, open-label Phase Ib/II study. The Phase Ib portion of the study is a dose escalation to estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by the triple combination of LEE011 + BYL719 with letrozole. The Phase Ib will be followed by a randomized Phase II study to assess the preliminary anti-tumor activity of the two double combination regimens (LEE011+letrozole and BYL719+letrozole) versus the triple combination (LEE011+BYL719 with letrozole) and to further evaluate their safety in patients with ER+/HER2- locally advanced or metastatic breast cancer. Approximately 300 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled. Breast Clinical Trials Unit Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 22

23 ROLLIS Randomised Controlled Trial Can Radio-guided Occult Lesion Localisation using Iodine-125 Seeds (ROLLIS) for excision of impalpable breast cancer reduce the rate of pathologically inadequate margins and /or subsequent oncological surgery compared with standard hook-wire localisation? A randomised controlled clinical trial. This study is comparing the use of low dose radioactive seeds to standard treatment for surgical removal guidance in breast cancer patients. Who is it for? You may be eligible to join this study, if you are a female aged 18 years or above and have been diagnosed with breast cancer that is non-palpable (i.e. the surgeon cannot feel it), and thus require a procedure known as localisation. Trial details: When an abnormal area in the breast needs to be removed after a needle biopsy (and the surgeon cannot feel it), the abnormal area is localised. We are comparing two different localisation techniques in this study. Participants will be randomly (by chance) assigned to one of two techniques. Participants in one group will undergo a procedure known as ROLLILS (radioguided occult lesion localisation and removal of impalpable breast cancers). This involves inserting a low-dose sterilised radioactive iodine seed into the patient's cancer under local anaesthesia with imaging guiding. The patient will then undergo breast conserving surgery within 4 days, during which the surgeon uses the seed to guide removal of the impalpable cancer. Participants in the other group will undergo the standard treatment, known as hook-wire guided localisation (HWL). This is when a hook-wire is placed in the breast on the day of breast conserving surgery by a radiologist. Participants are followed for up to 5 years post-surgery in order to evaluate clinical and cosmetic outcomes, disease recurrence and patient satisfaction. A cost benefit analysis will also be undertaken. This trial is open at Sir Charles Gairdiner Hospital and Royal Perth Hospital. Dr Shashi Aggarwal ROLLIS Research Coordinator Ph: (RPH) Ph: (SCGH) [email protected] Australia New Zealand Clinical Trials Registry [ACTRN ] Acknowledgements: Australia New Zealand Clinical Trials Registry 23

24 SANDPIPER Study A Phase III, Double-Blind, Placebo Controlled, Randomized Study Of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant In Postmenopausal Women With Estrogen Receptor-Positive And Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Have Disease Recurrence Or Progression During Or After Aromatase Inhibitor Therapy. This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)- negative, PIK3CA-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for patients with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years. Tamsyn Whitcher Murdoch Oncology Clinical Trials Unit Ph. (08) [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 24

25 STARS (TROG 08.06) A randomised comparison of anastrozole commenced before and continued during adjuvant radiotherapy for breast cancer versus anastrozole and subsequent anti-oestrogen therapy delayed until after radiotherapy. (STARS Study of Anastrozole and Radiotherapy Sequencing). The primary objective of the study is to determine if commencement of anastrozole prior to radiotherapy results in improved local control compared to anastrozole commenced after radiotherapy. Post-irradiation initiation of anastrozole is considered to be the standard arm. Secondary objectives will be an examination of rates of distant failure, overall survival, normal tissue complications and cosmetic outcomes after radiation. Who is it for? You can join this study if you are a woman who has had a mastectomy or lumpectomy for breast cancer, and all planned surgery is now complete. Trial details: Participants will be divided into two groups. One group will receive anastrozole orally before and during radiotherapy. The other group will receive standard treatment, where anastrozole and subsequent anti-oestrogen therapy is delayed until after radiotherapy. Participants will be monitored for 10 years after radiotherapy. The study aims to determine if commencement of anastrozole before radiotherapy results in improved local control of the disease. Perth Radiation Oncology Centre Ph. (08) US National Library of Medicine [NCT ] Australian New Zealand Clinical Trials Registry [ACTRN ] Trans-Tasman Radiation Oncology Group 25

26 TnAcity Study A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab - Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer. The purpose of this study is to compare the safety and efficacy of nabpaclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC). SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 26

27 Colorectal ALT GIST Study A Randomised Phase II Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST). An open label randomised trial for adults with histologically confirmed measurable metastatic GIST who have received no other treatment for metastatic disease. The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in comparison to imatinib alone to warrant further evaluation as a first line treatment for metastatic GIST. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 27

28 ASCOLT Study Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial. We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in this patient population over placebo control. If indeed found to be beneficial, because aspirin is cheap and easy to administer, it will positively impact the lives of many individuals in Asia and globally. SCGH Medical Oncology Ph. (08) St John of God Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 28

29 CHALLENGE Study A Phase III Study of the Impact of a Physical Activity Program on Disease- Free Survival in Patients With High Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial (CHALLENGE). This randomized phase III trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer. Participating in a physical activity program designed to increase free time physical activity and receiving written health education materials may influence the chance of cancer recurring as well as impact on physical fitness, psychological well-being and the quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It is not yet known whether giving a physical activity program together with health education materials is more effective than giving health education materials alone for patients who have undergone colon cancer treatment. Cancer Centre Clinical Trials Unit Caroline Stone Clinical Trials Manager Phone Fax [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 29

30 ICE CREAM Study Randomised Phase II study of cetuximab alone or in combination with irinotecan in patients with metastatic colorectal cancer (CRC) with either KRAS WT or G13D mutation. Who is it for? You can join this study if you have metastatic colorectal cancer and have either a KRAS wild type or KRAS G13D mutation Trial details: Patients that pass all screening assessments, including CT scan and blood test will randomly divided into two groups. One group wiil receive cetuximab alone ( Arm A) and the other group will receive cetuximab in combination with irinotecan ( Arm B). In both groups, the chemotherapy is given intravenously. Cetuximab is administered weekly to both groups and patients in Arm B will receive irinotecan every 14 days. The study aims to evaluate the response to the different therapy regimens, by looking at the response on CT scans, survival rates and quality of life. SCGH Medical Oncology Ph. (08) Australian New Zealand Clinical Trials Registry [ACTRN ] Acknowledgements: Australian New Zealand Clinical Trials Registry 30

31 LUME-1 Study A Double-blind, Randomised, Placebo Controlled Phase III Study of Nintedanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Colorectal Cancer Refractory to Standard Therapies. The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mcrc) after failure of previous treatment with standard chemotherapy and biological agents. SCGH Medical Oncology Ph. (08) Perth Oncology Dr Guy van Hazel Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 31

32 Gynaecological ARIEL 2 Study A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum- Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2). The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 32

33 ARIEL 3 Study A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients with Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer. Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to identify which of these groups of patients will most likely benefit from treatment with rucaparib. St John of God Ph. (08) SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 33

34 CAELYX YONDELIS Study A Randomized, Open-Label Study Comparing the Combination of YONDELIS and CAELYX With CAELYX Monotherapy for the Treatment of Advanced- Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer. The purpose of this study is to assess the efficacy and safety of trabectedin+doxil as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinumbased chemotherapy. St John of God Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 34

35 JIAE Lilly Ovarian Study A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study of LY , a p38 MAPK Inhibitor, Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin for Women With Platinum-Sensitive Ovarian Cancer. A study for women with ovarian cancer that has returned at least 6 months after platinum-based chemotherapy. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 35

36 Outback Study A Phase III trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone. This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with locally advanced cervical cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. External radiation therapy uses highenergy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet know whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kill more tumor cells. Who is it for? You can join this study if you have locally advanced cervical cancer which is suitable for primary treatment with chemoradiation and you have not received any previous pelvic radiotherapy. Trial details: Participants will be divided into two groups. Both groups will be treated with standard external beam radiation treatment to the pelvis and brachytherapy(internal radiotherapy). They will receive cisplatin intravenously during the radiation at a dose of 40mg/m2 weekly for 5 doses. One group will also receive 4 cycles of 3 weekly adjuvant chemotherapy using carboplatin and paclitaxel intravenously, beginning within 4 weeks of completion of all radiation treatment. The study aims to see whether the adjuvant chemotherapy increases the response to treatment and improves survival times. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Australian New Zealand Clinical Trials Registry [ACTRN ] Acknowledgements: US National Library of Medicine, Australian New Zealand Clinical Trials Registry. 36

37 OVAR 2.21 Study A Prospective Randomized Phase III Trial of Carboplatin/ Gemcitabine/ Bevacizumab vs. Carboplatin/ Pegylated Liposomal Doxorubicin/ Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer. Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin. SCGH Medical Oncology Ph. (08) St John of God Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 37

38 Haematology Trials includes Leukaemia, Lymphoma, Myeloma Acute Myeloid Leukaemia AML M16 Sorafenib in combination with intensive chemotherapy for previously untreated adult FLT3-ITD positive AML: a phase 2 randomised double-blind placebo controlled multi-centre study. The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for FLT3 positive AML, combined with or without Sorafenib, to find out which is better. This study will look at patients with a specific type of Acute Myeloid Leukaemia (AML) called FLT3 positive AML. This research is being done because we do not know whether the addition of Sorafenib to chemotherapy treatment is better than chemotherapy treatment alone for FLT3 positive AML. Sorafenib has been tested in over 8,400 patients and is being studied in a number of illnesses, including Acute Myeloid Leukaemia (AML) and in Kidney, Skin, Lung and Liver Cancer. Sorafenib blocks a cell surface receptor called FLT3, which has an important role in the survival and growth of AML cells. Not all leukaemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukaemia cells detected to have an abnormal FLT3 gene ( FLT3-positive AML ). Sorafenib is an investigational drug, which means it has not been approved for use in AML by government health authorities, such as the Australian Therapeutic Goods Administration (TGA) or any other agency, but is permitted to be tested in research studies such as this one. Sorafenib is only approved for use in Australia for certain types of Liver Cancer and Kidney Cancer. Haematology Care Centre Sir Charles Gairdner Hospital Ph. (08) Fax (08) [email protected] Australian New Zealand Clinical Trials Registry [ACTRN ] 38

39 AML M18 Australasian Leukaemia and Lymphoma Group Registry and Tissue Bank. Registries provide important regarding particular diseases. The data collected for this registry will allow clinicians and researchers to better understand the nature of AML and to plan future treatments, services and research. Specifically, on the characteristics of patients presenting with AML in Australia and New Zealand and how they are treated will be obtained. This will allow a better understanding on the outcome of AML in Australia and New Zealand and help design future clinical trials in AML. The data may be used to prepare manuscripts for publication in scientific journals but you will not be personally identifiable. The ALLG AML Registry will facilitate a number of functions associated with AML trials and thereby promote improved outcomes for patients. Some of the advantages to the establishment of the Registry are: 1. The Registry will enhance patient participation in clinical trials by facilitating cross referral of patients to sites that are running other ALLG AML trials. 2. The clear detail of tests to be conducted at baseline will align with ALLG AML clinical trial screening procedures to minimise burden on the patient and to ensure that the correct samples are collected, thus maximising participation in ALLG AML clinical trials. 3. The registry will also facilitate the implementation of central review and central testing of factors critical to the successful treatment of AML, and enhance consistency in clinical trial populations to ensure trial results are meaningful. 4. The collection of samples for the ALLG Tissue Bank, coupled with details and times of treatment and response status, provides a valuable resource not only for researchers wishing to access these samples through the ALLG Tissue Bank, but also allows stored tissue to be analysed for new prognostic markers and molecular subtypes to ensure that results from ongoing and completed clinical trials can be analysed incorporating stratification of these new entities. This ensures clinical trial results remain relevant in the current landscape of AML treatment. Haematology Care Centre Sir Charles Gairdner Hospital Ph. (08) Fax (08) [email protected] Australian New Zealand Clinical Trials Registry [ACTRN ] 39

40 QUAZAR Study A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best-supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission. Study to compare efficacy and safety of oral Azacitidine plus best supportive care versus best supportive care as maintenance therapy in Subjects with Acute Myeloid Leukemia (AML), age = or >55 years, who have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after induction with intensive chemotherapy with or without consolidation chemotherapy. Fiona Stanley Hospital Haematology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 40

41 Acute Lymphoblastic Leukaemia ALL6 Study A phase II trial of an intensive pediatric protocol incorporating post-induction stratification based on minimal residual disease levels for the treatment of adolescents aged 15 years and above, and young adults aged up to 40 years, with newly diagnosed acute lymphoblastic leukaemia (ALL). In this national study which will be carried out in a large number of Australian adult hospitals, a childhood ALL treatment program, which is currently being used in Children s hospitals in a separate national study, will be adapted for use in ALL patients aged 15 to 40 years, in order to find out whether this treatment can given as effectively as it can in young children. Patients will be started on a treatment protocol originally devised in Germany for use in children, and now used widely in other countries, including Australia. The first 2 months of treatment will be standard and given to all patients. This will involve being given several different chemotherapy drugs, according to a fixed schedule. Following this, treatment will depend on certain characteristics of the patient s leukaemia at diagnosis, and on the patient s response to the first 2 months of treatment. In the protocol that will be used in this study, the treatment given after the initial 2 months will be determined, as it is with children, by the risk group calculated for each individual patient. People who fit into Standard and Medium risk groups will be treated according to a particular protocol designed for children in these risk categories, while people who are shown to have high, medium high or very high risk disease will be given more intensive treatment, usually including bone marrow transplantation. Haematology Care Centre Sir Charles Gairdner Hospital Ph. (08) Fax (08) [email protected] Australian New Zealand Clinical Trials Registry [ACTRN ] 41

42 TOWER (EC REG ) Study A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study). This study seeks adult subjects with Relapsed/Refractory (R/R) B-precursor ALL. This is a phase 3 randomized, open label study designed to evaluate the efficacy of blinatumomab versus investigator choice of SOC chemotherapy. Adult subjects with R/R B-precursor ALL will be randomized in a 2:1 ratio to receive blinatumomab or treatment with investigator choice of 1 of 4 protocol defined SOC chemotherapy regimens. Primary Endpoint is Overall Survival. Fiona Stanley Hospital Haematology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 42

43 Chronic Lymphocytic Leukaemia MURANO GO28667 Trial A Study of GDC-0199 (ABT-199) Plus MabThera/Rituxan (Rituximab) Compared With Bendamustine Plus MabThera/Rituxan (Rituximab) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia This open-label, randomized study will compare the efficacy of GDC-0199 plus rituximab (GDC-0199+R) with bendamustine plus MabThera/Rituxan (Rituximab) (B+R) in patients with relapsed or resistant chronic lymphocytic leukemia. Patients will be randomized 1:1 into the two arms. Patients randomized to GDC-0199+R will be given GDC-0199 daily (oral, target dose 400 mg) and will receive 6 cycles of rituximab infused intravenously (IV) on Day 1 of each 28-day cycle (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2). Perth Blood Institute 3/95 Monash Avenue, Nedlands, WA [email protected] Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 43

44 Chronic Myeloid Leukaemia ENESTswift Trial Study to Assess Efficacy and Safety of Nilotinib 300mg Twice Daily in Patients With Philadelphia Positive Chronic Myeloid Leukaemia (CML) in Chronic Phase Who Are Intolerant to Prior Tyrosine Kinase Inhibitors (ENESTswift). The purpose of this study is to assess the efficacy and safety of nilotinib 300mg twice daily in patients with chronic myeloid leukemia chronic phase who are intolerant but responsive to 1st line treatment with imatinib or dasatinib. Eligible patients have been previously treated with imatinib or dasatinib for at least 3 months and are experiencing non-hematologic toxicity whilst having documented responses that meet PBS authority for 1st line treatment of CML without current MR4.5. Perth Blood Institute 3/95 Monash Avenue, Nedlands, WA [email protected] Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 44

45 The Australasian RESIST Study (CML10) Response Post Tyrosine Kinase Inhibitor: Assessment of Sensitivity and Therapeutic Response to Next-Line Therapy in CML. The aims of the TKI registry are to: collect about reasons for stopping Tyrosine Kinase Inhibitor (TKI) treatment, to determine the time to stopping TKI treatment and to determine overall survival and progression free survival of patients enrolled onto the TKI registry. The aims of the STOP registry are to: determine the clinical status of patients changing to further treatment, to collect about selection of further treatment, to collect about overall survival and progression free survival of patients, to assess the association between patient disease and treatment response with reasons for stoping treatment, too assess the association between patient response and further treatment selected, to determine the rate and success of transplants, to determine the frequency and reasons for stopping treatment, to determining the rate and outcomes of pregnancy and to determine patients' response to further treatment. In Australia and New Zealand, an estimated 70 chronic myeloid leukaemia (CML) will stop imatinib and start another therapy or observation each year. The reasons for stopping will include resistance to imatinib, worsening of CML, intolerance to imatinib, other illness, and pregnancy. A smaller number will cease Tyrosine Kinase Inhibitor (TKI) treatment and move onto another treatment. The actual frequency of patients stopping TKI treatment, the type of further treatment selected and the outcome of further treatment have not been well studied. This study will consist of two registries and a laboratory study. In order to determine the reasons for and frequency of stopping TKI treatment, a TKI registry of patients with CML on TKI treatment will be set up. The STOP registry will aim to capture data on all consenting patients in Australia and New Zealand who switch or stop their current TKI. All patients on the STOP registry will have regular blood analysis of PCR and mutation done in order to characterise the range of mutations that occur with TKI treatment. Patients who are not pre-registered on the TKI registry will still be eligible for the STOP registry and Correlative studies. The Correlative studies will investigate other tests designed to better predict patient's response to further treatment. Haematology Care Centre Fremantle Hospital Sir Charles Gairdner Hospital Ph. (08) Ph. (08) Fax (08) [email protected] Australian New Zealand Clinical Trials Registry [ACTRN ] 45

46 Hodgkin s Lymphoma Millennium Study A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma. This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mpfs) obtained with brentuximab vedotin (ADCETRIS ) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma (HL). Fiona Stanley Hospital Haematology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 46

47 Non-Hodgkin s Lymphoma BGB-3111 Study A Phase I, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects with B-Cell Lymphoid Malignancies. To investigate the safety and action of the study drug BGB-3111 in Subjects with B-Cell Lymphoid Malignancies. This is a first-in-human study of a new drug called BGB-3111 to see what effects (good and bad) it has on you and your cancer. The purpose of this study is to (1) determine if this drug is safe for human use, and (2) find the most effective dose of this drug as a treatment for your disease. A key purpose of this part of the study is to determine whether once or twice daily dosing is better at targeting the cancer. BGB-3111 is an experimental treatment. This means that it is not an approved treatment for B-Cell Lymphoid Malignancies in Australia. Haematology Care Centre Sir Charles Gairdner Hospital Ph. (08) Fax (08) [email protected] US National Library of Medicine [NCT ] 47

48 C25001 Study A Randomized Open-Label Phase 3 Trial of brentuximab vedotin (SGN-35) versus Physician's Choice (Methotrexate or Bexarotene) in Patients with CD30-Positive Cutaneous T-Cell Lymphoma. The main purpose of this research study is to determine if brentuximab vedotin (SGN-35) improves the outcome of treatment in patients with Cutaneous T Cell Lymphoma over selected standard therapy (methotrexate). The side effects of brentuximab vedotin (SGN-35) will be looked at and additional research tests will be performed to monitor disease. If eligible to participate, patients will be randomly assigned (like the flip of a coin) to receive either brentuximab vedotin (SGN-35) or a standard therapy (methotrexate). Patients will have a 50% chance (1 in 2) of receiving brentuximab vedotin (SGN-35) and a 50% chance (1 in 2) of receiving standard therapy. If assigned to receive brentuximab vedotin (SGN-35), they will receive study drug every 21 days. Each 21 day treatment period is called a cycle, and brentuximab vedotin (SGN-35) is given on the first day of the cycle. They may receive it for up to 48 weeks (16 cycles). Brentuximab vedotin (SGN-35) will be given as an intravenous (through a vein) infusion over approximately 30 minutes. The dose of brentuximab vedotin (SGN-35) is 1.8 milligrams per kilogram so the total amount of brentuximab vedotin (SGN-35) will be based on weight. If assigned to receive a standard therapy, Methotrexate will be given as a pill to be taken once a week for three week (21-day) cycles and can be taken at home. The dose of methotrexate will be decided by the study doctor and will be between 5 and 50 mg. Haematology Care Centre Sir Charles Gairdner Hospital Ph. (08) Fax (08) [email protected] US National Library of Medicine [NCT ] 48

49 GS-US Study (EC REG ) A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas. This study is to evaluate the effect of the addition of idelalisib (GS-1101) to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-hodgkin lymphoma (inhl). Fiona Stanley Hospital Haematology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 49

50 NHL24 Trial - Primary Central Nervous System Lymphoma Rituximab in Primary Central Nervous system Lymphoma (PCNSL): A randomized HOVOLLG intergroup study. The objective of the current study is to investigate whether the addition of intravenous Rituximab to a standard chemo- and radiotherapy regimen results in improved event-free survival (EFS). To find out whether treatment with rituximab is better than treatment without rituximab, participants will be divided into two groups. In order to balance the groups this division will be decided by a chance process. This process is called randomisation. By comparing the two groups it can be found out whether the addition of rituximab improves the effect of treatment and whether it does not disproportionally increase side-effects compared to standard treatment. Haematology Care Centre Sir Charles Gairdner Hospital Ph. (08) Fax (08) [email protected] Australian New Zealand Clinical Trials Registry [ACTRN ] 50

51 Phoenix Study A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI (Ibrutinib), in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma (Phoenix Study). The purpose of this study is to compare the effects of ibrutinib when it is given in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) to R-CHOP and placebo alone. R-CHOP is the standard treatment already used to treat Diffuse Large B-Cell Lymphoma. Placebo looks just like ibrutinib and is given the same way but has no active drug in it. The experimental drug used in this study is called ibrutinib (also known as PCI-32765). Ibrutinib is being tested to see if it may be useful in treating people with the non-germinal Center B-Cell (non-gcb) subtype of Diffuse Large B-Cell Lymphoma who have not received any treatment for the disease before (newly diagnosed). At the same time, ibrutinib is being tested in other studies, in other illnesses. So far more than 500 people have taken Ibrutinib in several other research studies. Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that help cells live and grow. The study drug is believed to block a kinase that helps blood cancer cells live and grow and by blocking this, it is possible that the study drug will kill cancer cells or stop them from growing. In this study, ibrutinib will be added to the standard chemotherapy to see if it may be useful in patients with non-gcb Diffuse Large B-cell Lymphoma, who have not been treated for this disease before. Ibrutinib is being co-developed by Janssen Research and Development LLC and Pharmacyclics Inc. Haematology Care Centre Sir Charles Gairdner Hospital Ph. (08) Fax (08) [email protected] US National Library of Medicine [NCT ] 51

52 Multiple Myeloma There are currently no Multiple Myeloma trials available for listing. Bone Marrow Transplant ALLG BM07 A Treatment Algorithm Evaluating the Effect of Zoledronic Acid on Bone Mineral Density Loss after Allogeneic Stem Cell Transplantation. Zometa as a prophylactic treatment for bone mineral density loss in cancer patients following allogeneic stem cell transplantation. A side-effect of allogeneic stem cell transplantation is a big loss in bone strength. Bone-strength is also called "bone mineral density" (BMD). One of the problems with a loss in bone strength is a higher risk of osteoporosis and bone fractures later in life. Hence, we are keen to look at ways by which this loss in bone-strength can be minimised. A group of drugs, called bisphosphonates, have been shown to reduce the rate of bone-strength loss after transplants. The current study is a follow-on study that will use a newer and more powerful bisphosphonate drug called zoledronic acid or Zometa. Zometa will be given to all patients before transplant but after transplant it will only be given to those patients whose bone mineral density (BMD) scan shows a >3% loss of bone density or to patients who receive large doses of prednisolone (steroid therapy). The aim is to use Zometa only when it is needed. The main measure of the success of the study is whether we can stop bone density loss, which will be calculated by comparing the results of the pretransplant scan with those from the scans at day 100 and 12 months after the transplant. Fiona Stanley Hospital Haematology Ph. (08) Australian New Zealand Clinical Trials Registry [ACTRN ] Acknowledgements: Australian New Zealand Clinical Trials Registry 52

53 CTTWA Phase II MSC Trial A Phase 2 Trial of Standard of Care Treatment Versus Mesenchymal Stromal Cell Therapy Together With Standard of Care for the Treatment of de Novo Acute Graft Versus Host Disease Following Allogeneic Bone Marrow Transplantation. A randomised study of corticosteroid therapy with or without mesenchymal stromal cell therapy for newly diagnosed acute graft versus host disease after bone marrow transplantation or donor lymphocyte therapy. It is hypothesised that mesenchymal stromal cell therapy will be superior. Fiona Stanley Hospital Haematology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 53

54 Myelodysplasic Syndrome MDS BLAST Trial Study of Azacitidine with or without Birinapant in Subjects with MDS or CMMoL (MDS BLAST). This is a randomised double blind placebo controlled study of azacitidine with or without birinapant in subjects with higher risk myelodysplastic syndrome, secondary MDS or myelomonocytic leukaemia (CMMoL) who are naïve to azacitidine therapy. Perth Blood Institute 3/95 Monash Avenue, Nedlands, WA [email protected] Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 54

55 Other Haematology Trials C16011 Study A Phase 3 Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physician s Choice of Treatment Administered to Patients with Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis. The purpose of this study is to find out if MLN9708 plus dexamethasone improves against systemic light chain amyloidosis better than the physician s choice chemotherapy treatment. Physician s choice chemotherapy treatment is a treatment regimen that is commonly used to treat amyloidosis patients. The study will also determine if MLN9708 plus dexamethasone can change the chance that the amyloidosis will cause heart and/or kidneys to begin to work poorly needing care in the hospital or of dying. Another purpose of this study is to see how differences in DNA, RNA and proteins related to the disease may influence the way people respond to MLN9708. This may be used by the Sponsor of this study, Millennium Pharmaceuticals, its agents and its affiliated companies for research related to analysis and development of MLN9708 and associated disease states, for example: to develop a better understanding of how people s genes affect the safety and effectiveness of MLN9708 to help develop new ways to monitor and treat cancer to generate needed for research, development and regulatory approval of diagnostic tests related to diseases or conditions that MLN9708 might treat Patients will be randomly assigned (like flipping a coin) to one of two treatment groups (Arm A or Arm B). They have an equal (one in two) chance of being in either Arm A or Arm B. They will receive all study drugs orally (by mouth). Arm A (Dexamethasone plus MLN9708) MLN9708 (4.0 mg) on days 1, 8, and 15 plus dexamethasone (20 mg) weekly on days 1, 8, 15, and 22 of each 28-day cycle. Arm B (Physician s Choice - patients will receive one of the five following treatments Dexamethasone (20 mg) on days 1-4; days 9-12; and days of each 28-day cycle. Dexamethasone (20 mg) on days 1-4 of each 28-day cycle plus melphalan (0.22 mg/kg body weight) on days 1-4 every 28 days. Dexamethasone (20 mg) weekly on days 1, 8, 15, and 22 of each 28-day cycle plus cyclophosphamide (500 mg) on days 1, 8, and 15 every 28 days. Dexamethasone (20 mg) weekly on days 1, 8, 15, and 22 of each 28-day cycle plus daily thalidomide (200 mg/day). The starting dose of thalidomide is 50 mg This may be increase up to 200 mg if patients are tolerating the drug well. 55

56 Dexamethasone (20 mg) weekly on days 1, 8, 15, and 22 of each 28-day cycle plus lenalidomide (15 mg/day) for days 1-21 of each 28 day cycle. The duration of treatment will depend upon how patients are feeling, how well they tolerate the study drug and how the disease responds to the study drug. If they are responding to therapy they will continue to receive the study drugs as long as the disease continues to respond to it for as long as the study doctor feels it is in patients' best interest. Approximately 248 participants at approximately 55 centres in Australia, North America, Europe, and the rest of the world will participate in this study. Haematology Care Centre Sir Charles Gairdner Hospital Ph. (08) Fax (08) US National Library of Medicine [NCT ] 56

57 KaloBios Trial Study of the Anti-EphA3 Monoclonal Antibody KB004 in Subjects With EphA3-Expressing Hematologic Malignancies. The purpose of this study is to determine a maximum tolerated dose (MTD) for KB004 when administered once weekly by intravenous (IV) infusion to subjects with hematologic malignancies who meet the entry criteria. Fiona Stanley Hospital Haematology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 57

58 MEPO Study Mepolizumab Compassionate Use Supply Program (SB MHE104317). The purpose of this programme is to provide a treatment option to patients with life-threatening Hypereosinophilic Syndrome (HES) whose symptoms are not controlled with other therapies and to provide continued access to mepolizumab for subjects who received clinical benefit in Study MHE following termination of the study. Eligible patients will receive a supply of Mepolizumab for monthly infusions with up to 10mg/kg (maximum dose 750mg or 10mg/kg if body weight less than 45kg) Mepolizumab IV for an initial three months of treatment. The duration and frequency of additional treatment with Mepolizumab will be determined based on the subject s response to the initial three months of treatment as demonstrated by significant lowering of eosinophil level and/or decreased signs and symptoms of HES. Haematology Care Centre Sir Charles Gairdner Hospital Ph. (08) Fax (08) [email protected] US National Library of Medicine [NCT ] 58

59 MM13 Trial A randomized openlabel multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic lightchain (AL) amyloidosis (MM13). This research will investigate whether the addition of bortezomib to the standard treatment of melphalan and dexamethasone will improve outcomes in AL amyloidosis without causing excessive side effects. To find out whether treatment with bortezomib is better than treatment without bortezomib, participants will be divided into two groups. In order to balance the groups this division will be decided by a chance process (like flipping a coin). This process is called randomisation. Neither you nor your doctor are able to influence which treatment you will receive. You will be randomized to receive one of the two following treatments, either MDex: = oral melphalan and dexamethasone for 4 consecutive days every 28 days, or BMDex: = cycles 1 and 2: MDex with bortezomib intravenously (i.v.) on days 1, 4, 8 and 11 of a 28 day cycle, cycles 3-8: MDex with bortezomib i.v. on days 1, 8, 15 and 22 of a 35 day cycle. Patients will be administered MDex for up to 9 cycles or BMDex for up to 8 cycles. Haematology Clinical Trials, Cancer Centre, Sir Charles Gairdner Hospital Ph. (08) Fax (08) [email protected] Australian New Zealand Clinical Trials Registry [ACTRN ] Acknowledgements: Australian New Zealand Clinical Trials Registry 59

60 MPN01 Registry Australasian Leukaemia and Lymphoma Group Myeloproliferative Neoplasms Registry. The aim of this registry is collect on patients in Australia and New Zealand who have been diagnosed with a myeloproliferative neoplasm (polycythaemia vera, essential thrombocythaemia, primary myelofibrosis, chronic eosinophilic leukaemia) or a related disorder (hypereosinophilic syndrome, refractory anaemia with ringed sideroblasts associated with a marked thrombocytosis) and to understand the nature of the disease in the local area. The registry is an observational study and participating does not mandate the performance of investigations and does not recommend any treatment. The registry will collect at the time the blood disorder was diagnosed which will include about the haematological disease, the presence of comorbidities (other illnesses), family history of blood disorders, complications present in the disease and any therapies started. More will be collected for the registry every 12 months on the progress of the disease, its therapy and any complications that may have developed for as long as the registry remains open. Patients will be offered the opportunity to complete a quality-of-life assessment (MPNSAF: myeloproliferative neoplasm symptom assessment form) within the first three months of diagnosis and on an annual basis. There will not be any requirement to attend any additional appointments through participation in the MPN01 registry. Patients will be asked to provide consent to obtain additional blood, bone marrow & saliva samples If they wish to take part in the optional scientific studies. Haematology Care Centre Sir Charles Gairdner Hospital Ph. (08) Fax (08) [email protected] Australian New Zealand Clinical Trials Registry [ACTRN ] 60

61 PERSIST2 PAC326 Myelofibrosis Trial Oral Pacritinib Versus Best Available Therapy to Treat Myelofibrosis With Thrombocytopenia (PAC326). The primary hypothesis of the study is that treatment with either once-daily or twice-daily pacritinib results in a greater proportion of patients with thrombocytopenia and myelofibrosis achieving 35% reduction in spleen volume from baseline to Week 24 than treatment with Best Available Therapy, and a greater proportion of patients achieving a 50% reduction in total symptom score from baseline to Week 24 as measured by the Myeloproliferative Neoplasm Symptom Assessment Form 2.0. Perth Blood Institute 3/95 Monash Avenue, Nedlands, WA [email protected] Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 61

62 PNH Registry Paroxysmal Nocturnal Hemaglobinuria (PNH) Registry: A prospective, multicentre, multi-national, non-interventional study (no procedures or tests) designed to capture safety and effectiveness data for eculizumab, as well as to compile data on the natural history and management of patients with PNH. To enhance the understanding of PNH demographics and natural history. To capture the long-term outcomes of patients in order to better guide and assess therapeutic interventions and the safety of eculizumab. To serve as a global resource for PNH. The registry will enrol patients treated with eculizumab for any reason, as well as patients with PNH. Clinical data will be collected from patients enrolled in this study. Participants will also be required to complete six monthly quality of life questionnaires. Haematology Care Centre, Fiona Stanley Hospital Haematology Sir Charles Gairdner Hospital Ph. (08) Ph. (08) Fax (08) [email protected] Perth Blood Institute 3/95 Monash Avenue, Nedlands, WA [email protected] Ph. (08)

63 TIMES MRI Trial An Epidemiological Study to Assess the Prevalence of Iron Overload Using MRI in Patients With Transfusional Siderosis (TIMES Study). Iron, one of the most common elements in nature and the most abundant transition metal in the body, is readily capable of accepting and donating electrons. This capability makes iron a useful component of various, essential biochemical processes. Despite the essential role of iron, the excess of iron is toxic to the human body. It is critical for the human body to maintain iron balance, since humans have no physiologic mechanism for actively removing iron from the body. The development of iron overload occurs when iron intake exceeds the body's capacity to safely store the iron in the liver, which is the primary store for iron. Long-term transfusion therapy, a life-giving treatment for patients with intractable chronic anemia is currently the most frequent cause of secondary iron overload. The mounting evidence regarding the mortality and morbidity due to chronic iron overload in transfusion dependent anaemias has led to the establishment of guidelines that aim the improvement of patient outcomes. prospective studies are warranted in order to assess the impact of iron overload in patients with acquired anaemias. In this study, non-invasive R2- and T2*-MRI techniques will be applied to the liver and the heart, respectively, to complement the primary variable (serum ferritin) assessed in patients with various transfusion-dependent anaemias. The main objective of this study is to assess the prevalence and severity of cardiac and liver siderosis in patients with transfusional siderosis. This study will also aim to establish possible correlations between cardiac and liver iron levels with clinical effects in patients with different transfusion-dependent anaemias. Patients will be eligible for enrollment irrespective of receiving chelation therapy or not (and irrespective of the chelating agent used). Fiona Stanley Hospital Haematology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 63

64 TTP Registry Thrombotic Thrombocytopenic Purpura (TTP) Registry. The aims of the TTP Registry are to: Better define the incidence, natural history, specific clinical characteristics, and clinical outcome of patients with TTP and HUS. Provide on the range of therapeutic strategies employed in the treatment of TTP and HUS patients. Explore factors influencing clinical outcomes. Help define optimal management of patients with TTP and HUS. Inform and inspire future hypothesis-driven research in this area. The TTP Registry will be a register of patients who develop TTP in any clinical setting. Clinical data collection will be undertaken by clinicians in specialist units at participating hospitals. Data management and analysis will be undertaken by the Department of Epidemiology and Preventive Medicine (DEPM), Monash University and interpreted with the input of Transfusion Medicine Specialists at ARCBS and specialist clinicians on the Registry Steering Committee. The Registry began collecting data in December Patients are identified either by the treating clinician, or by ARCBS clinicians as a result of referral for provision of blood components for therapy. Patient liaison and registration will take place in participating hospitals. Recruitment strategies take advantage of the fact that all patients will require blood component therapy provided by ARCBS, and patients are largely managed by a small group of specialised clinicians in a limited number of major centres with apheresis facilities. Registry staff will maintain close interaction with key individuals working in relevant hospital clinical care areas to ensure notification of all patients. Haematology Care Centre Sir Charles Gairdner Hospital Ph. (08) Fax (08) [email protected] 64

65 Head and Neck Eating As Treatment (EAT Trial) TROG Eating As Treatment (EAT): A stepped wedge, randomised control trial of a health behaviour change intervention provided by dietitians to improve nutrition in head and neck cancer patients undergoing radiotherapy. Poor nutrition is an important issue for people receiving radiotherapy treatment for head and neck cancer. Evidence suggests that one way to improve nutrition amongst these patients may be to change the way that nutrition interventions are delivered by dietitians. The purpose of this research trial is to investigate whether a dietitian-delivered health behaviour intervention will help to improve nutrition amongst patients with head and neck cancer (HNC). This trial builds on previous data that shows that health behaviour interventions may reduce malnutrition in HNC patients undergoing radiotherapy. This is a national trial that will evaluate a specific health behaviour intervention. It is designed to improve health behaviours of HNC patients and help them to maintain their nutrition throughout cancer treatment. SCGH Radiation Oncology Ph. (08)

66 Metastatic Head and Neck Squamous Cell Carcinoma Study A Phase Ib Dose Escalation/Randomized Phase II, Multicenter, Open-label Study of BYL719 in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. This is a multi-center, open-label, Phase Ib dose escalation / Phase II study. The aim of the Phase Ib is to determine the Maximum Tolerated Dose(s) (MTD(s)) and/or the Recommended Phase II Dose(s) (RP2D(s)) for BYL719 in combination with cetuximab in recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) patients considered to be resistant, ineligible or intolerant to platinum-based chemotherapy. The Phase II part will assess the clinical efficacy of BYL719 in combination with cetuximab in two patient populations: patients will be assigned to one of two schemes of enrollment based on prior therapy with cetuximab. Cancer Centre Clinical Trials Unit Caroline Stone Clinical Trials Manager Phone Fax [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 66

67 Lung Cancer and Mesothelioma Lung Cancer AURA3 Study A Phase III, Open Label, Randomized Study of AZD9291 Versus Platinum- Based Doublet Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose Tumours Harbour a T790M Mutation Within the Epidermal Growth Factor Receptor Gene (AURA3). The primary objective of the study is to assess the efficacy of AZD9291 versus platinum-based doublet chemotherapy by assessment of progression free survival (PFS) according to RECIST 1.1. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 67

68 CA (Opening October 2015) An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC). The purpose of this study is to show that Nivolumab or Nivolumab plus ipilimumab, improves progression free survival and/or overall survival compared with chemotherapy in subjects advanced lung cancer. Tamsyn Whitcher Murdoch Oncology Clinical Trials Unit Ph. (08) [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 68

69 CA (Opening October 2015) An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivolumab Clinical Trial Evaluation 331). The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC. Tamsyn Whitcher Murdoch Oncology Clinical Trials Unit Ph. (08) [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 69

70 FLAURA-1 Study A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer. To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 70

71 Mesothelioma COMMAND Study A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma. To compare the overall survival (OS) in subjects with malignant pleural mesothelioma receiving defactinib (VS-6063) or placebo. To compare the progression free survival (PFS) in subjects with malignant pleural mesothelioma receiving defactinib (VS-6063) or placebo. To assess Quality of Life (QoL) in subjects treated with defactinib (VS-6063) or placebo using the Lung Cancer Symptom Scale modified for mesothelioma (LCSS-Meso). SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 71

72 Phase 1 and Other Cancers IMRT Intensity modulated radiotherapy prospective data collection. To evaluate the intensity modulated radiotherapy (IMRT) technique of treating cancers. The primary aim of the data collection study is to document the local recurrence rates, patterns of recurrence and overall survival rates for those treated with IMRT. Another important outcome of the study is the documentation of both acute and late toxicity of this treatment. The results of the IMRT treatment program may be published in a peerreviewed journal, where non identifying will be used. Perth Radiation Oncology Centre Ph. (08)

73 Linear Advanced Solid Tumours Study (HMPL-504) A Phase 1, Open-label, Dose-Escalation Study of the Safety and Pharmacokinetics of HMPL-504 in Patients with Advanced Solid Tumours. Volitinib (HMPL-504) is a novel, highly potent and selective small molecule inhibitor of c-met kinase. In preclinical studies, it demonstrated strong in vitro and in vivo activity against c-met kinase and its downstream signaling targets and inhibited tumor cell growth. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HMPL-504 at single doses and multiple doses. Linear Clinical Research Ltd Phase 1 Unit Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 73

74 Linear Advanced Solid Tumours Study PG545 An open-label, multi-centre Phase I Study of the safety and tolerability of IV infused PG545 in patients with advanced solid tumours. This Phase 1a study aims to establish the maximum tolerated dose of onceweekly IV infused PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition, the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread. Linear Clinical Research Ltd Phase 1 Unit Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 74

75 Linear Advanced Solid Tumours and Lymphomas Study A Phase 1, Open Label, Multi-Center, Dose Escalation Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Intravenously Administered APG-1387 in Patients with Advanced Solid Tumours and Lymphomas. This study aims to establish the safety and best tolerated dose of a new investigational drug called APG-1387 in participants with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have been diagnosed with an advanced solid tumour or lymphoma. Study details: All participants in this study will be treated with a new investigational drug called APG This drug blocks tumour growth by promoting cell death (a process called apoptosis) in cancer cells and attempts to stop the cancer cells from spreading further throughout the body. This drug has not previously been tested in humans. APG-1387 has undergone extensive testing in various animal models (including rats and monkeys) and human cancer cell models in the laboratory. APG-1387 will be administered via intravenous (IV) infusion (i.e. directly into the vein) on Days 1, 8 and 15 of study participation. The first group of participants will receive a dose of 0.3 mg of APG-1387, and if tolerated the dose will be increased for subsequent patient groups. Participants will be regularly monitored until they reach their endpoint (disease progression, intolerable toxicity or withdrawal of consent) in order to determine safety, tolerability and preliminary efficacy of treatment. The results from this study will be analysed to see if it is worthwhile for this new drug to be tested in future studies involving larger numbers of cancer participants. Linear Clinical Research Ltd Phase 1 Unit Ph. (08) Australian New Zealand Clinical Trials Registry [ACTRN ] Acknowledgements: Australian New Zealand Clinical Trials Registry. 75

76 Linear HER-3 Positive Solid Tumours Study A phase I, first time in human, open-label, dose escalation study to investigate the safety, pharmacokinetics, and pharmacodynamics of anti- HER3 monoclonal antibody GSK in subjects with advanced HER3- positive solid tumours. Human Epidermal Growth Factor Receptor 3 (HER3) expression is seen across a wide variety of solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression and activity is also associated with resistance to multiple pathway inhibitors. GSK , a monoclonal antibody targeting HER3, is a new agent for subjects whose tumors express HER3. This study is a phase I, first time in human, open-label, dose escalation study. The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GSK in subjects with advanced HER3-positive solid tumors. The study will be conducted in two parts. Part 1 (Dose-Escalation Phase) will include dose escalation and PK/PD cohorts to evaluate safety, PK, and PD to guide selection of dose regimen(s) for Part 2. In Part 2 (Expansion Cohorts), up to 3 cohorts will be enrolled at the dose regimen(s) selected based on Part 1 data, to evaluate safety in a larger cohort of subjects at the recommended dose regimen and also to evaluate preliminary evidence of clinical benefit. Linear Clinical Research Ltd Phase 1 Unit Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 76

77 P3BEP Germ Cell Tumour Study Phase 3 Accelerated BEP Trial: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours. The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours. Who is it for? You may be eligible to join this study if you are a male aged 16 years to 45 years old and you have been diagnosed with metastatic germ cell tumour/s in the testes, retro-peritoneum or mediastinum. Study details: Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current gold standard treatment for germ cell tumours, which is a chemotherapy combination called BEP (bleomycin, etoposide and cisplatin) administered on a 3 weekly cycle. BEP is given with a drug called pegfilgrastim which encourages white blood cell production and prevents blood cell complications of chemotherapy. Participants in the other group will receive the same dose of BEP but on a 2 weekly schedule. This is called 'accelerated BEP'. Cancer Centre Clinical Trials Unit Caroline Stone Clinical Trials Manager Phone Fax [email protected] Australian New Zealand Clinical Trials Registry [ACTRN ] Acknowledgements: Australian New Zealand Clinical Trials Registry 77

78 Prostate CBCT - Image Guided Radiation Therapy Cone Beam Computed Tomography: The future of image guided RT. To evaluate conventional electronic portal imaging using Cone Beam Computed Tomography (CBCT) sectional images as the benchmark. To evaluate Cone beam CT for its usefulness and accuracy for identifying the prostate gland in planning. To implement a pilot study of a novel imaging technique Limited-angle cone-beam digital tomosynthesis (LA-CBDT) and quantify the efficacy of the technique. To perform a detailed cost-benefit analysis of practicable Image guided radiation treatment modalities. This study is for men who need radiation therapy for prostate cancer. It will investigate using advanced prostate localisation x-ray imaging to make sure the radiation beams are on the target every day. This imaging is called Cone Beam Computed Tomography or CBCT. CBCT is similar to CAT scan. It provides three-dimensional images of the treatment target volume while you are on the treatment machine and lying in the treatment position. Phase 1 of the study will recruit 25 consenting patients who will be treated with the usual 7 week course of radiation using conventional Electronic portal imaging. Weekly CBCT investigations will be done and this will incur an additional exposure to low energy x-radiation. This additional dose is 0.2% of the prescribed therapeutic dose of 74 Gy. Phase 2 and 3 will be done concurrently, with the aim to recruit 50 patients. Patients will have 3 small gold markers permanently implanted into the prostate gland. This procedure will be done by the urologist prior to commencing radiation therapy. The radiation remains 7 weeks of treatment as is standard for all prostate patients. For phase 2 there will be additional CBCT scans which will incur an additional exposure to low energy radiation. This equates to 0.4 % of your prescribed radiation dose. Perth Radiation Oncology Centre Ph. (08) Australian New Zealand Clinical Trials Registry [ACTRN ] 78

79 ENZAMET Study Randomised phase 3 trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer: ENZAMET. A randomised study of male participants with metastatic prostate cancer in treatment with a luteinising releasing hormone releasing hormone analogue (LHRHA) or surgical castration combined with the commencement of either 160mg daily Enzalutamide or conventional Non-steroidal anti-androgen (NSAA) to determine the effects of overall survival. Participants are invited to take part in this research study to test a new treatment combination for prostate cancer. This is because they have cancer that started in the prostate and has spread to other parts of their body. This is known as metastatic prostate cancer. Current treatment for newly diagnosed metastatic prostate cancer involves androgen deprivation therapy(adt). Androgen deprivation therapy has two components: 1. The main component is by stopping the release of androgen from the testicles. This is mainly done by using drugs that prevent the testicles from making androgens, and therefore reducing the levels of androgens in the body to low levels. These drugs are called luteinising hormone releasing hormone analogues (LHRHA). These drugs are given as injections. This is usually part of the standard initial treatment for men in your situation. The other way of reducing androgen production by the testicles is with a surgical operation to remove both testicles. This is not part of the trial. If participants have already had this surgical procedure or it is planned to be done, they will not need to be on LHRHA, but can still take part in this study. 2. The second component of ADT is to block the effects of androgens produced in other parts of the body with antiandrogen drugs. Antiandrogen drugs block testosterone and related androgens from attaching to molecules in the cancer cell called 'androgen receptors'. Blocking this attachment prevents androgens from having their effect. This might provide additional benefit in treating the cancer although this has not yet been proven. Several different types of antiandrogen drugs are available for use already. Enzalutamide is a new antiandrogen that is not yet approved for use in Australia. This study will compare the effectiveness of enzalutamide versus the currently available antiandrogen drugs when used on a background of treatment with a LHRHA (or surgical removal of the testicles). The main aim of the study is to see which of these combinations is best at improving the survival of men in this situation. Recent studies show promising results with the use of enzalutamide in participants who had been treated with androgen deprivation therapy and were no longer responding to the standard antiandrogens, this is known as castrate resistant prostate cancer (CRPC), which is a more advanced stage than the type of metastatic prostate cancer being studied here. With this stage of metastatic prostate cancer there is no evidence yet on which treatment is best to treat it. To do this, a total of 1100 participants will participate where half the participants on the study will receive enzalutamide with a LHRHA or surgical operation to remove both testicles and the other half (550 participants) will receive already available 79

80 antiandrogens (but not enzalutamide) with a LHRHA or surgical operation to remove testicles. All participants on this study will receive active therapy and no placebo treatment will be used. The study is open label, meaning that both the participants and the investigators will know the treatment the participant will receive. Cancer Centre Clinical Trials Unit Caroline Stone Clinical Trials Manager Phone Fax [email protected] Australian New Zealand Clinical Trials Registry [ACTRN ] Acknowledgements: Australian New Zealand Clinical Trials Registry 80

81 IMAGE GUIDED RADIATION THERAPY Image guided Radiation Therapy for Prostate Cancer. Image guided radiation therapy (IGRT) is a new method of using advanced imaging technology to accurately image and track the movement of your prostate cancer during the course of your radiotherapy treatment. Accurate tracking of the prostate cancer is essential to resolve daily prostate location changes due to normal organ motion and body position variation on the treatment couch. IGRT will ensure high dose radiotherapy can be precisely delivered to the prostate cancer while limiting the dose to normal surrounding sensitive tissues like rectum and bladder. To assist with Image guided radiation therapy (IGRT), three gold markers are inserted into the prostate gland to serve as reference landmarks for your prostate location and to guide the accurate delivery of radiation therapy to your prostate cancer. Gold marker insertion requires patient consent. It also requires taking a course of antibiotics, starting prior to the radiation treatment. Bowel preparation is also important prior to gold marker insertion. Perth Radiation Oncology Centre Ph. (08)

82 ProCare Trial A Phase II randomised controlled trial of follow up of men with prostate cancer in primary care, to assess the acceptability and feasiblity of a shared care model. To develop and test a shared care model of 12 month follow up (between hospital and GPs) for men treated for prostate cancer and that aims to reduce psychological distress and unmet psychosocial and psychosexual needs. The study hypothesis is that a shared care model of follow-up for prostate cancer is feasible, and demonstrates the potential to reduce rates of psychological distress and unmet psychosocial and psychosexual needs and improve satisfaction with care, at lower cost compared to usual care. Fremantle Hospital Ph. (08) Australian New Zealand Clinical Trials Registry [ACTRN ] Acknowledgements: Australian New Zealand Clinical Trials Registry 82

83 RAVES (TROG 08.03) A phase III multi-centre randomised trial comparing adjuvant radiotherapy (RT) with early salvage RT in patients with positive margins or extraprostatic disease following radical prostatectomy. The purpose of the study is: To see which of two ways of managing men with high risk features is better in controlling PSA in the long term. To see how treatment and illness affect quality of life and feelings (mood) This study is for men who have had surgery to remove prostate cancer and the features of the cancer (as determined by a pathologist after the surgery) indicate the risk of the PSA rising again may be higher than other patients. There are currently two ways to manage these men: Immediate radiotherapy which is a course of radiotherapy to the area where the prostate gland used to be. The radiotherapy is given over about 6 and a half weeks (5 times a week). It is now known from several large studies that giving radiotherapy to everyone immediately after surgery will halve the risk of the PSA rising again. This means that only half of the men who have radiotherapy benefit from it. Unfortunately we don t know which men benefit from radiotherapy and which don t. It would be simple to give everyone radiotherapy if there were no side effects but many men experience unpleasant side effects. The second way to manage these men is to watch them very closely ( active surveillance ) with regular clinic visits and regular PSA blood tests. The PSA blood test can detect activity of the cancer months or years before other tests and usually long before any symptoms appear. Radiotherapy is only given if the PSA starts to rise. In this situation nearly half the patients would be spared the possible side effects of radiotherapy. It is not known whether these 2 ways of managing men with high risk features are the same in controlling the PSA long term. The aim of the study is to therefore see whether patients treated with active surveillance (and giving radiotherapy as soon as the PSA rises) is as good as immediate radiotherapy. This study will also compare the side effects occurring in each treatment group and what affect the treatments have on quality of life. It will also compare whether the 2 ways of managing men with high risk features results in the same percentage of men who are alive and without prostate cancer. Perth Radiation Oncology Centre RPH Radiation Oncology Ph. (08) Ph. (08)

84 SCGH Radiation Oncology Fremantle Hospital Ph. (08) Ph. (08) US National Library of Medicine [NCT ] 84

85 SPARTAN Study A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer. The purpose of this study is to evaluate the efficacy and safety of ARN-509 in adult men with high-risk non-metastatic castration-resistant prostate cancer. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 85

86 Quality of Life, Survivorship and Lifestyle Exercise and Bone Metastatic Disease Study Title Feasibility and efficacy of resistance exercise in cancer patients with bone metastases. The additional complications experiences by cancer patients who have bone metastases prevent them from following established exercise guidelines. This study will determine the safety and efficacy of resistance exercise in cancer survivors with bone metastases. Participation in this study is anticipated to improve physical function, enhance balance and reduced risk of falls as well as improve quality of life and psychological distress in patients with no increase the incidence of skeletal fractures or incidence and severity of bone pain. Inclusion criteria: bone metastases secondary to prostate or breast cancer. Exclusion criteria: significant bone pain affecting the ability to perform activities of daily living. Edith Cowan University Health and Wellness Institute. Sites available: Joondalup, Mt Lawley, Crawley, Fremantle and South Lake. Patients who may be eligible for any of these projects can contact our team for further on or at Links 86

87 Exercise and High Grade Glioma Study Title Safety and efficacy of exercise during adjuvant treatment of high-grade glioma. This project will determine if exercise is a feasible, acceptable, safe and efficacious therapy to counteract adverse treatment-related effects and improve patient outcomes in patients with high-grade glioma. Gliomas are the commonest primary brain tumour with high-grade glioma constituting 70% of all gliomas. High-grade glioma is a devastating diagnosis, both because of its high mortality, and because of the profound effect on brain function often immediately after diagnosis. Sufferers lose function and independence early, resulting in a high social burden and financial cost to both individuals and the healthcare system. Patients undergo treatments including combined chemoradiotherapy and corticosteroids cause significant fatigue, weight gain, insomnia, proximal myopathy and mood disturbance. This project will determine if exercise is a feasible, acceptable, safe and efficacious therapy to counteract adverse treatment-related effects and improve patient outcomes in patients with high-grade glioma. Inclusion criteria: Scheduled to receive combined chemoradiotherapy for the treatment of high-grade glioma. Exclusion criteria: ECOG performance status >1 and neurological deficits which would preclude full participation in the exercise program. Edith Cowan University Health and Wellness Institute. Sites available: Sir Charles Gairdner Hospital Cancer Centre, Joondalup, Mt Lawley, Crawley, Fremantle and Murdoch. Patients who may be eligible for any of these projects can contact our team for further on or at [email protected]. Links 87

88 Exercise and Prostate Cancer Study Title The effect of an exercise intervention in prostate cancer patients initiating androgen suppression therapy. This study will determine if immediate exercise therapy can improve patient health by attenuating initial adverse effects during the initial phase of androgen suppression therapy (AST) and if this provides superior benefits to delayed exercise therapy. Participation in this study is anticipated to reduce some of the adverse side effects of AST and improve physical function, body composition, quality of life and psychological distress in patients. Inclusion criteria: scheduled to initiate androgen suppression therapy for the treatment of prostate cancer; Exclusion criteria: bone metastases. Edith Cowan University Health and Wellness Institute. Sites available: Joondalup, Mt Lawley, Crawley, Fremantle, South Lake and Bunbury. Patients who may be eligible for any of these projects can contact our team for further on or at Links 88

89 Finding My Way Finding My Way - Coping with Cancer Online Finding My Way is an internet based intervention that provides a convenient, user friendly way to gain and/or skills to improve your physical and mental well being during your treatment for cancer. Please visit the Finding My Way website for more. Flinders University [email protected] Links 89

90 Improving sexual health in men with prostate cancer Title Improving sexual health in men with prostate cancer: randomised controlled trial of exercise and psychosexual therapies. This project examines whether exercise aids in the management of sexual dysfunction and explores if an integrated treatment model incorporating pharmacological, exercise and psychosexual therapies maximises improvement in sexual health. Sexual dysfunction is one of the most common and distressing side effects of prostate cancer. Despite being a critical survivorship care issue, there is a clear gap in knowledge surrounding the optimal treatment of sexual dysfunction in men with prostate cancer. Inclusion criteria: Concerned by your sexual wellbeing; prior/current treatment for prostate cancer including prostatectomy, radiotherapy or ADT. Exclusion criteria: Non-nerve sparing prostatectomy; > 6 months since prostatectomy or completion of radiotherapy or ADT; incontinence defined as requiring the use of > 1 pad in a 24-hour period. Edith Cowan University Health and Wellness Institute. Sites available: Joondalup, Mt Lawley, Crawley, Fremantle and Murdoch. Patients who may be eligible for any of these projects can contact our team for further on or at [email protected]. Links 90

91 Preventing chemo-brain in breast cancer patients Title Preventing chemo-brain : Can exercise mitigate chemotherapy-induced cognitive impairment in breast cancer patients? This project will determine if exercise reduces or even prevents cognitive impairment in breast cancer patients receiving chemotherapy. Cognitive impairment is a common side-effect of chemotherapy that can persist well after the completion of treatment. The thinking and memory problems commonly referred to as chemo-brain or chemo-fog have a significant impact on quality of life, adversely influencing daily activities, work performance and interpersonal relationships. Currently, no well-validated treatment options exist for preventing or reducing chemotherapy-induced cognitive deficits. Exercise has a positive effect on overall brain health, resulting in improvements in cognitive function in healthy adults as well as patients with impaired cognition (e.g. Alzheimer s disease, stroke). Inclusion criteria: Scheduled to receive chemotherapy for the treatment of breast cancer. Exclusion criteria: A pre-existing cognitive impairment. Edith Cowan University Health and Wellness Institute. Sites available: Joondalup, Mt Lawley, Crawley, Fremantle and Murdoch. Patients who may be eligible for any of these projects can contact our team for further on or at [email protected]. Links 91

92 Skin Cancer BMS CA Study A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivolumab Clinical Trial Evaluation 238). The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 92

93 BRF Study A Rollover Study to Provide Continued Treatment With GSK to Subjects With BRAF Mutation-Positive Tumors. This rollover study is designed to provide continued access to GSK for eligible subjects with BRAF mutation-positive tumors who have previously participated in a GlaxoSmithKline (GSK)-sponsored GSK study (parent study), who have no evidence of progressive disease and who have tolerated GSK in the parent study without significant toxicities. Subjects will be enrolled into the appropriate cohort based upon the treatment received in their parent study. Safety assessments (physical examinations, vital signs, 12-lead electrocardiograms, echocardiograms, clinical laboratory assessments, and monitoring of adverse events) will be made throughout the study. Clinical activity will be assessed using local standard of care imaging practices and the appropriate response criteria as determined by the investigator. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 93

94 COLUMBUS Study A Phase III Randomized, 3-arm, Open Label, Multicenter Study of LGX818 Plus MEK162 and LGX818 Monotherapy Compared With Vemurafenib in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma. A prospective, randomized, open label, multi-center, parallel group, 3-arm phase III study comparing the efficacy and safety of both, LGX818 plus MEK162 and LGX818 monotherapy, as compared to vemurafenib in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized 1:1:1 to one of 3 treatment arms: 1) LGX818 plus MEK162 (denoted as Combination arm), 2) LGX818 monotherapy (denoted as LGX818 arm), 3) vemurafenib. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 94

95 EMR Merkel Cell Carcinoma Study A Phase II, Open-label, Multicenter Trial to Investigate the Clinical Activity and Safety of MSB C in Subjects With Merkel Cell Carcinoma. This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of MSB C in subjects with metastatic Merkel cell carcinoma (MCC) who must have received one line of chemotherapy for the treatment of metastatic MCC. St John of God Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 95

96 Tin Foil Nose study Tin Foil Nose Study Prospective follow up study of all Skin cancers of the nose treated with the PRO Tin Foil technique. To assess the cosmetic outcomes of the Tin foil technique for treating nonmelanomatous skin cancers of the nose. The second aim is to assess the impact of this treatment on patients quality of life and assess their satisfaction with the treatment. There are a number of different treatments available for the treatment of nonmelanomatous skin cancer. These include radiation treatment, moh s surgery, electrodessication, curettage (EDC) and local excision. There is very little on patient s quality of life following radiation. In Australia the cost of radiation treatment is not as high as in United States which means that it is an alternate treatment to surgery. The technical aspects of the tin foil technique developed at PRO have been presented in the past, but there is little on the patient s satisfaction with the outcome. This study looks at local recurrence rates, patterns of recurrence, acute and late side effects of radiation, Cosmesis (what the nose looks like from both doctors and patients viewpoint) and patients quality of life pre and post treatment and satisfaction with the treatment overall. Perth Radiation Oncology Centre Ph. (08)

97 TROG Merkel PET Phase II Protocol (MP3 Study) A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin, TROG The purpose of this study is to develop a well-tolerated and effective regimen for Merkel Cell carcinoma (MCC) using chemotherapy and radiation therapy. This study will look at combining radiation therapy and the chemotherapy drugs Carboplatin and Etoposide to be given after your surgery to improve both local and distant control of cancer spread. Also the study will assess the use of PET Scan to determine how useful PET scanning is in planning your radiotherapy treatment and in assessing your response to treatment. Merkel Cell Carcinoma (MCC) is an aggressive form of skin cancer that has the potential to spread beyond the skin to other sites in the body. Historically, surgery has been the primary treatment for this condition but if surgery is not followed by a course of radiotherapy, the risk of the cancer coming back in the same place is high. Previous studies have shown that the inclusion of chemotherapy has the potential to reduce the chance of this cancer spreading to other parts of the body and while the recent results from other clinical research studies have been positive, the optimal chemotherapy drug and dose is unknown. The primary purpose of this study is to develop a well tolerated and effective regimen for MCC using chemotherapy and radiation therapy. This study will look at combining radiation therapy and the chemotherapy drugs Carboplatin and Etoposide to be given after your surgery to improve both local and distant control of cancer spread. Another purpose of the study is to assess the use of Positron Emission Tomography (PET - a type of imaging procedure that allows us to see any cancer activity that cannot usually be seen on a Computer Tomography (CT) scan). To date, the use of PET scanning in patients with MCC has not been used extensively so this study will aim to determine how useful PET scanning is in planning your radiotherapy treatment and in assessing your response to treatment. It is planned that approximately 50 patients will participate in this study from centres in Australia and New Zealand. SCGH Radiation Oncology Ph. (08) TROG Cancer Research 97

98 Upper Gastrointestinal, Pancreatic and Liver ABI-007-PANC-003 (CELGENE) Adjuvant Pancreatic Study A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma. The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in subjects with surgically removed pancreatic cancer who then take nab-paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone. St John of God Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 98

99 ALT GIST Study A Randomised Phase II Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST). An open label randomised trial for adults with histologically confirmed measurable metastatic GIST who have received no other treatment for metastatic disease. The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in comparison to imatinib alone to warrant further evaluation as a first line treatment for metastatic GIST. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 99

100 HELOISE Study A randomized, open-label, multicenter Phase IIIb study comparing two Trastuzumab dosing regimens, each in combination with cisplatin/capecitabine chemotherapy, as first-line therapy in patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. This randomized, open-label, multicenter, international phase IIIb study will compare the efficacy and safety of two Herceptin (trastuzumab) dosing regimens in combination with cisplatin/capecitabine chemotherapy in patients with metastatic gastric or gastro-esophageal junction adenocarcinoma. Patients who have not received prior treatment for metastatic disease will be randomized to receive Herceptin intravenously either an 8 mg/kg loading dose followed by 6 mg/kg every 3 weeks or an 8 mg/kg loading dose followed by 10 mg/kg every 3 weeks. Capecitabine will be administered for 6 cycles at a dose of 800 mg/m2 orally twice on Days 1-14 of each 3-week cycle, cisplatin will be administered intravenously for 6 cycles at a dose of 80 mg/m2 on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression occurs. Tamsyn Whitcher Murdoch Oncology Clinical Trials Unit Ph. (08) [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 100

101 JACOB Study A Double-Blind, Placebo-Controlled, Randomised, Multicentre Phase III Study Evaluating the Efficiency and Safety of Pertuzumab in Combination with Trastuzumab and Chemotherapy in Patients with HER2-Positive Metastatic Gastroesophageal Junction and Gastric Cancer. This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab), fluoropyrimidine and cisplatin as first-line treatment in patients with HER2-positive metastatic gastroesophageal junction or gastric cancer. Patients will be randomized to receive Perjeta 840 mg or placebo intravenously (iv) every 3 weeks in combination with Herceptin (initial dose of 8 mg/kg iv followed by 6 mg/kg iv every 3 weeks) and cisplatin and fluoropyrimidine (capecitabine or 5- fluorouracil) for the first 6 treatment cycles. Patients will continue to receive Perjeta or placebo and Herceptin until disease progression or unacceptable toxicity occurs. SCGH Medical Oncology Ph. (08) US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine 101

102 TOPGEAR (TROG 08.08) A randomised phase II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer. The primary objective is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving pathological complete response (pcr) rates in the first instance, and subsequently overall survival, in patients undergoing adequate surgery (D1 dissection) for resectable gastric cancer. The optimal management of patients with resectable gastric cancer continues to evolve. Chemotherapy regimes are better, radiation techniques have improved and there is an increasing interest in the use of chemoradiotherapy prior to surgery for gastric cancer. The important question addressed in this trial is whether chemoradiation is better than chemotherapy alone in the treatment of resectable gastric cancer. Perth Radiation Oncology Centre Ph. (08) SCGH Radiation Oncology Ph. (08) Trans-Tasman Radiation Oncology Group Australian New Zealand Clinical Trials Registry [ACTRN ] 102

103 YOSEMITE Study A 3-Arm Phase 2 Double-Blind Randomized Study of Gemcitabine, Abraxane Plus Placebo Versus Gemcitabine, Abraxane Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma. This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma. The purpose is to test the efficacy and safety of demcizumab, when given in combination with gemcitabine and Abraxane compared to placebo. The administration of gemcitabine and Abraxane is a standard treatment for patients with metastatic pancreatic ductal adenocarcinoma. Tamsyn Whitcher Murdoch Oncology Clinical Trials Unit Ph. (08) [email protected] US National Library of Medicine [NCT ] Acknowledgements: US National Library of Medicine. 103