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Gemcitabine Cisplatin with OGX-427
Clinical Trial Information - Bladder Cancer
Gemcitabine Cisplatin with OGX-427
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
Objective:
This study is being sponsored by OncoGenex Technologies Inc. They want to find out if treatment with gemcitabine, cisplatin and study drug (OGX-427) at two different doses (600 mg and 1000 mg) can increase survival in subjects with TCC compared to gemcitabine, cisplatin and placebo. A placebo is a medication which contains no active ingredient. The study will also see if OGX-427 at two different dose levels is safe when given with gemcitabine and cisplatin.
Design:
About 180 people will participate in this study across 40-50 international sites. All subjects will receive gemcitabine and cisplatin. About 60 subjects will receive OGX-427 at the 600 mg dose, 60 will receive OGX-427 at the 1000 mg dose, and 60 will receive placebo.
If you are eligible, you will be randomly assigned to one of three following treatment groups:
- Arm A: three loading doses of placebo followed by weekly placebo plus chemotherapy
- Arm B: three loading doses of OGX-427 (600 mg) followed by weekly OGX-427 (600 mg) plus chemotherapy
- Arm C: three loading doses of OGX-427 (600 mg) followed by weekly OGX-427
(1000 mg) plus chemotherapy
All subjects will receive the same amount of gemcitabine and cisplatin chemotherapy.
Investigator: Steven Wong, MD
Sponsor: OncoGenex Technologies, INC.
For more information
For information on inclusion and exclusion criteria please call our Clinical Trials Office - 310-206-5930
