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Objectives: Custirsen (OGX-011), a novel inhibitor of testosterone-repressed prostate message-2 (TRPM-2), sensitizes cells to chemotherapy. This randomized, open-label, phase III trial is designed to confirm that adding it to standard first-line treatment with docetaxel (Taxotere) and prednisone can slow tumor progression and improve overall survival.
Key entry or exclusion criteria: Patients must have evidence of progression, and be willing to continue primary androgen suppression throughout the study, unless treated with bilateral orchiectomy. Men who received any other cytotoxic chemotherapy as treatment for prostate cancer are excluded.
Locations: 140 sites.
Goal: 1,000 patients.
Study sponsor: Teva Pharmaceutical Industries in collaboration with OncoGenex Technologies.
Link for more information: clinicaltrials.gov/ct2/show/NCT01188187
NIH clinical trials identifier: NCT01188187
Objectives: Custirsen (OGX-011), a novel inhibitor of testosterone-repressed prostate message-2 (TRPM-2), sensitizes cells to chemotherapy. This randomized, open-label, phase III trial is designed to confirm that adding it to standard first-line treatment with docetaxel (Taxotere) and prednisone can slow tumor progression and improve overall survival.
Key entry or exclusion criteria: Patients must have evidence of progression, and be willing to continue primary androgen suppression throughout the study, unless treated with bilateral orchiectomy. Men who received any other cytotoxic chemotherapy as treatment for prostate cancer are excluded.
Locations: 140 sites.
Goal: 1,000 patients.
Study sponsor: Teva Pharmaceutical Industries in collaboration with OncoGenex Technologies.
Link for more information: clinicaltrials.gov/ct2/show/NCT01188187
NIH clinical trials identifier: NCT01188187
Objectives: Custirsen (OGX-011), a novel inhibitor of testosterone-repressed prostate message-2 (TRPM-2), sensitizes cells to chemotherapy. This randomized, open-label, phase III trial is designed to confirm that adding it to standard first-line treatment with docetaxel (Taxotere) and prednisone can slow tumor progression and improve overall survival.
Key entry or exclusion criteria: Patients must have evidence of progression, and be willing to continue primary androgen suppression throughout the study, unless treated with bilateral orchiectomy. Men who received any other cytotoxic chemotherapy as treatment for prostate cancer are excluded.
Locations: 140 sites.
Goal: 1,000 patients.
Study sponsor: Teva Pharmaceutical Industries in collaboration with OncoGenex Technologies.
Link for more information: clinicaltrials.gov/ct2/show/NCT01188187
NIH clinical trials identifier: NCT01188187