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A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination With OGX-427 or Placebo in Patients With Advanced Transitional Cell Carcinoma
The primary objective of this study is to ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm.
Details
| Lead sponsor | Achieve Life Sciences |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 183 |
| Start date | 2011-10 |
| Completion | 2014-11 |
Conditions
- Urologic Neoplasms
- Metastatic Bladder Cancer
- Urinary Tract Neoplasms
Interventions
- OGX-427 600 mg
- OGX-427 1000 mg
- Placebo
- Gemcitabine
- Cisplatin
- Carboplatin
Primary outcomes
- Overall Survival (OS) — Baseline to date of death by any cause (up to approximately 12 months)
OS is defined as the time from randomization to death from any cause; OS was censored on date of last contact for participants still alive at time of analysis.
Countries
United States, Canada, France, Germany, Italy, Poland, Spain