Prostate Cancer Studies

Transcription

1 Prostate Cancer Studies STUDIES CURRENTLY RECRUITING MDV A multinational, Phase 3, Randomized, Double- Blind, Placebo-Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastic Castration-Resistant Prostate Cancer Dendreon P12-2 A Randomized, Open-Label, Phase 2 Study of Sipuleucel-T with Concurrent versus sequential Administration of Enzalutamidein Men with Metastatic castrate resistant prostate cancer ARN SPARTAN Study Phase III study comparing ARN-509 (pill) to placebo for patients with non-metastatic prostate cancer Galeterone - TOK ARMOR 2 study 2 part Phase II study of galeterone -TOK (pill) for patients with metastatic prostate cancer pre and post-chemotherapy OGX-011 (Custersin) + Jevtana Phase III study of Jevtana +/- Custersin second line chemotherapy for patients with metastatic prostate cancer Prolia (denosunab) Phase III study to evaluate Prolia for patients with prostate cancer taking hormones Prostvac (vaccine) Phase III study vaccination study for patients with advanced prostate cancer who have not yet received treatment with chemotherapy and have no symptoms or minimal symptoms

2 Provenge PROCEED study (vaccine) Registry study to collect long term safety data for patients receiving Provenge vaccine Provenge PROCEED sub - study Immune response study (additional blood samples collected) for patients participating in PROCEED study PSMA ADC Phase II study of PSMA ADC (target chemotherapy) in patients with metastatic prostate cancer who have failed chemotherapy VT-464-CL-001 (testosterone inhibitor) Phase I/II study to evaluate the safety of the study drug VT-464 (pill) and how it affects patients with prostate cancer XL184 (Cabozantinib) Phase II study comparing XL184 (Cabozantinib) (pill) vs. Prednisone only for patients who have failed Zytiga (abiraterone) or Xtandi (MDV3100) Xtandi (MDV 3100) - STRIVE Phase II study comparing Xtandi to standard of care Casodex for patients with Prostate cancer Androgen deprivation vs. Radiotherapy Phase III study comparing androgen deprivation prior with pelvic lymph node dissection vs. radiotherapy only Taxotere Phase III study to evaluate the addition of Taxotere prior to surgery to improve outcome for patients with newly diagnosed high risk prostate cancer Taxotere +/- GM-CSF Phase II study of intermittent Taxotere vs. intermittent Taxotere with GM-CSF

3 STUDIES ACTIVE, CLOSED TO ENROLLMENT Zytiga Rising PSA IMAAGEN study Phase III study of Zytiga plus prednisone for patients with rising PSA prostate cancer who are receiving hormone therapy Closed to enrollment active follow-up TAK-700 (Orteronel) Pre-chemotherapy Phase III study of TAK-700 plus prednisone for patients with advanced prostate cancer who have not yet received treatment with chemotherapy Closed to enrollment active follow-up TAK-700 (Orteronel) Post-chemotherapy Phase III study of TAK-700 plus prednisone for patients with advanced prostate cancer previously treated with chemotherapy Closed to enrollment active follow-up TAK-700 (Orteronel) Phase II Open-label study of oral TAK-700 plus prednisone, evaluating the effects on the heart for patients with advanced prostate cancer Closed to enrollment active follow-up TAK-700 (Orteronel) Phase II Open-label study of oral TAK-700 plus prednisone, evaluating dosing options for patients with advanced prostate cancer Closed to enrollment active followup Zytiga Cougar 302 study Phase III study of oral Zytiga plus prednisone for patients with advanced prostate cancer who have not yet received treatment with chemotherapy Closed to enrollment active follow-up Zytiga + Provenge Open-label Phase II study of Provenge with concurrent or sequential Zytiga. Closed to enrollment active follow-up PRIOR STUDIES - CLOSED Genentec GDC + Zytiga Phase II study of GDC + Zytiga, versus Zytiga alone for patients with advanced prostate cancer previously treated with chemotherapy Closed

4 Zytiga Cougar 301 study Phase III study of oral Zytiga plus prednisone for patients with advanced prostate cancer who have already received chemotherapy Closed Zytiga EAP study EAP oral Zytiga plus prednisone for patients with advanced prostate cancer who have already received chemotherapy Closed MDV3100 EAP study EAP oral MDV3100 for patients with advanced prostate cancer who have already received chemotherapy Closed TroVax Phase II study to evaluate the addition of TroVax vaccination to standard Taxotere chemotherapy for patients with advanced prostate cancer Closed OGX-011 (Custersin) Phase III study of OGX-011 (Custersin) added to Taxotere for second line treatment evaluation of pain palliation Closed Eligard +/- Taxotere - Rising PSA A Phase III study Eligard +/- Taxotere for patients with Rising PSA Closed Bladder Cancer Studies DN24-02 (vaccination) DN24-02 (vaccination) added to standard of care treatment for patients with HER2+ bladder cancer Avastin added to Gemcitabine + Cisplatin chemotherapy Phase II study comparing Avastin, Gemcitabine + Cisplatin chemotherapy to Gemcitabine + Cisplatin alone

5 Intravesical chemotherapy with Gemcitabine, Mitomycin Taxotere Treatment for superficial bladder cancer in which chemotherapy drugs are infused directly into the bladder through a catheter (intravesical) Bladder preservation Bladder preservation with chemotherapy prior to surgery, TURBT (transurethral resection of bladder tumor), concurrent radiation + chemotherapy STUDIES ACTIVE, CLOSED TO ENROLLMENT OGX added to Gemcitabine + Cisplatin chemotherapy Phase II study of Gemcitabine + Cisplatin chemotherapy with study drug OGX for advanced bladder cancer Closed to enrollment active follow-up Kidney Cancer Studies AVE0005 (veg trap) Phase II study to determine the effects of two different doses of AVE0005 (veg trap) in patients with advanced kidney cancer Sutent Treatment with Sutent (pill) prior to surgery/cryosurgery AGS An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)