Studies open voor inclusie Afdeling Medische Oncologie Fase I onderzoek en farmacokinetiek studies MOGE13 - M14AFS MOGYN10 - ISA-HPV-01-12 MOHN03 - cbyl719, Cetuximab MOMEL03 - LEE011xMEK162 MOMULT05 - SYD985.001 MOMULT06 - DIET MOMULT10 - HER117158 MOSAR09 - ABILITY MOGE15 - CL002-872 MOURO06 - LDcyclo Everolimus Phase I/II study with the combination of afatinib and selumetinib in advanced KRAS mutant positive and PIK3CA wildtype colorectal, non-small cell lung and pancreatic cancer A multicenter, open label phase I/II study to determine the safety and immune modulating effects of the therapeutic Human Papilloma Virus type 16 (HPV16) E5/E7 synthetic long peptides vaccine (ISA101) at different doses with or without interferon alpha as combination therapy with carboplatin and paclitaxel in women with HPV16 positive advanced or recurrent cervical cancer who have no curative treatment options 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. A phase Ib/II, multicenter,open label, study of LEE011 in combination with MEK162 in adult patients with NRAS mutant melanoma A two part first-in-human phase I study (with expanded cohorts) with the antibody-drug-conjugate SYD985 to evaluate the safety, pharmacokinetics and efficacy in patients with locally advanced or metastatic solid tumors Improving the tolerability of the oral targeted anticancer drug pazopanib by food intake A phase I, first time in human, open-label, dose escalation study to investigate the safety, pharmacokinetcis and pharmacodynamics of anti-her3 monoclonal antibody GSK2849330 in subjects with advanced HER-3 positive solid tumors Influence of an acidic beverage (Coca-Cola) on the exposure to Imatinib (Glivec) after major gastrectomy in patients with gastrointestinal stroma tumors An open-label phase Ib study to evaluate the safety and efficacy of CCX872-B in patients with pancreatic adenocarcinoma Phase I-II study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer Ottevanger, P.B. Erp, van P.H. Graaf, van der W.T.A. Oktober 2015 1
Gastro-enterologische tumoren MOGE01 - ORCHESTRA MOGE03 - EORTC40091 / BOS2 MOGE04 - RAPIDO MOGE05 - ART DECO MOGE06 - IMPACT CRC Colon A randomized multicenter clinical trial for patients with multi-organ, colorectal cancer metastases comparing the combination of chemotherapy and maximal tumor debulking versus chemotherapy alone Randomized phase II trial evaluating the efficacy of FOLFOX alone, FOLFOX plus bevacizumab and FOLFOX plus panitumumab as perioperative treatment in patients with resectable liver metastases from wild type KRAS colorectal cancer Randomized multicentre phase III study of short course radiation therapy followed by prolonged pre-operative chemotherapy and surgery in primary high risk rectal cancer compared to standard chemotherapy and surgery and optional adjuvant chemotherapy A randomized trial of dose escalation in definitive chemoradiotherapy for patients with oesophageal cancer. Image guided treatment optimalization with cetuximab for patients with metastatic colorectal cancer MOGE07 - JANUS2 MOGE09 - CAIRO4 MOGE10 - SILENT MOGE11 - CRITICS MOGE16 - PREOPANC MOGE19 - PELICAN A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 2 Study) The role of surgery of the primary tumour with few or absent symtoms in patients with synchronous unresectable metastases of colon cancer Accelerated growth of synchronous colorectal liver metastases: effects of neoadjuvant therapy A multicentre randomised phase III trial of neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy in resectable gastric cancer Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer: a multicentre randomized phase III clinical trial Pancreatic Locally advanced Irresectable Cancer Ablation in the Netherlands Graaf, van der W.T.A. Stommel, M. MOGE20 - COLOPEC MOGE21 - CHARISMA Adjuvant hyperthermic intraperitoneal chemotherapy in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial Neo-adjuvant chemotherapy followed by surgery versus surgery alone in highrisk patients with resectable colorectal liver metastases Bremers, A.J.A. Oktober 2015 2
Gynaecologische tumoren MOGYN09 - INOVATYON MOGYN13 - OVHIPEC Phase III international, randomized study of Trabectedin plus Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer progressing within 6-13 months of last platinum Phase III randomised clinical trial for stage III ovarian carcinoma randomising between secondary debulking surgery with or without hyperhermic intraperitoneal chemotherapy Ottevanger, P.B. Ottevanger, P.B. Hoofd-hals tumoren MOHN06 - EORTC 1209- EnTF MOHN07 - PRONE MOHN08- MK3475-040 A phase II study exploring the safety and efficacy of nintedanib (BIBF1120) as secondline therapy for patients with either differentiated or medullary thyroid cancer progressing after first line therapy. Prediction of ototoxicity and nephrotoxicity in patients with locally advanced head and neck cancer treated with cisplatin-containing chemoradiotherapy A Phase III Randomized Trial of MK-3475 (Pembrolizumab) versus Standard Treatment in Subjects with Recurrent or Metastatic Head and Neck Cancer Netea-Maier, R.T. Mamma tumoren MOMAM01 - COBRA Change of body composition in breast cancer: all-in assessment MOMAM02 - PREVENT MOMAM08 - BOOG stop&go MOMAM10 - IMPACT MBC - Breast Prediction of everolimus-induced interstitial lung disease in breast cancer patients; maximizing efficacy by reducing toxicity An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer Towards patient tailored cancer treatment supported by molecular imaging IMPACT: imaging patients for cancer drug selection - metastatic breast cancer C.M.L MOMAM11 - INPRES Influence of exceptional patient characteristics on everolimus exposure Oktober 2015 3
MOMAM12 - AFTER MOMAM15- SPOT A randomized, prospective trial of 3 weeks pre-operative hormonal treatment for hormone receptor positive breast cancer Dried blood SPOT analysis of everolimus in cancer patients (SPOT-study) Dermatologische tumoren (melanoom) MOMEL06 - COLUMBUS MOMEL16 - REPOSIT MOMEL23 - DC Melanoma 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 phase II, open-label multicenter study of vemurafenib plus cobimetinib (GDC- 0973) in unresectable stage IIIc or metastatic melanoma Myeloid and plasmacytoid blood dendritic cells for immunotherpay of stage III melanoma patients scheduled for radical lymph node dissection Koornstra, R.H.T. Koornstra, R.H.T. Neuro-oncologische tumoren MONEU04 - EORTC26053 / CATNON Phase III trial on concurrent and adjuvant temozolomide chemotherapy in non- 1p/19q deleted anaplastic glioma. The CATNON intergroup trial. Gijtenbeek, J.M.M. Miscellaneous MOMIS01 - PROSKIN MOMIS02 - Biopsy protocol Prospective, observational practice survey of applied skin care and management of cetuximab related skin reactions Development of a platform for next-generation DNA sequencing based personalized treatment for cancer patients: Protocol to obtain biopsies from patients with locally advanced (incurable) or metastatic cancer (CPCT - 02 biopsy protocol) Oktober 2015 4
Urologische tumoren MOURO02 - SURE MOURO04 - VIABLE MOURO05 - ERA 223 BAY88-8223- 15396 MOURO07 - IMPACT mrcc - Nier Phase II study of sunitinib rechallenge in patients with metastatic renal cell carcinoma A randomized, double blind, multicenter, parallel-group, phase III study to evaluate efficacy and safety of DCVAC/Pca versus placebo in men with metastatic castration resistant prostate cancer eligible for 1st line chemotherapy A phase III randomized, double-blind, placebo controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naive subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC). Watchful waiting in patients with good and intermediate risk metastatic clear cell renal cell carcinoma (mccrcc); an imaging guided observational approach Mulder, S.F. MOURO11 - MK3475-045 MOURO15- vaccinatie mcrpc A Phase III Randomized Clinical Trial of MK-3475 versus Paclitaxel or Vinflunine in Subjects with Recurrent or Progressive Metastatic Urothelial Cancer A randomized phase lla study: natural dendritic cells for immunotherapy of chemo-naive metastatic castration-resistant prostate cancer patients MOURO - BNITprostvac 301 (via Urologie) A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer MOURO - OPTIMUM (via Urologie) MOURO - ILUMINATE (via Urologie) Optimizing abiraterone (Zytiga ) therapy by exploring the relation between an early biomarker - drug exposure - as a predictor for drug response in patients with mcrpc (OPTIMUM study) Personalizing enzalutamide (Xtandi ) therapy by understanding the relation between the decrease in the expression profile of a panel of preselected microrna's, tumor related mrna's and treatment response in chemotherapy naive patients with mcrpc (ILUMINATE) Oktober 2015 5
Bot en weke delen tumoren MOSAR01 - CREATE MOSAR03 - PREDICT Cross-tumoral phase II clinical trial exploring crizotinib (PF-02341066) in patients with advanced tumors induced by casual alterations of ALK and/or MET Individualizing pazopanib therapy by exploring the role of early metabolic response and drug exposure as a predictor for treatment outcome in patients with STS. Graaf, van der W.T.A. Oktober 2015 6