drugset / Trial / NCT00887822
A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer
RandomizedParallel-groupDouble-blindTreatment
Summary
This 2 arm study will compare the efficacy and safety of bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin in participants who have not received prior chemotherapy for advanced or metastatic gastric cancer. Participants will be randomized to one of two treatment groups Bevacizumab + Capecitabine/Cisplatin (experimental arm) or Placebo + Capecitabine/Cisplatin (control arm).
Timeline
- Start
- 2009-03
- Primary completion
- 2011-05
- Completion
- 2014-08
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Bevacizumab, Capecitabine and Cisplatin vs Placebo, Capecitabine and Cisplatin; p = 0.8636; NCT00887822 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |