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A Phase 1b Open-Label, Multi-Center Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With High-Risk Stage I and Stages II-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancers. The hypothesis is that AMG 386 in combination with carboplatin and paclitaxel is safe and well tolerated.
Details
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 27 |
| Start date | 2010-11 |
| Completion | 2015-01 |
Conditions
- Carcinoma
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal Cancer
Interventions
- AMG 386, paclitaxel and carboplatin
Primary outcomes
- To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancers. — 18 weeks of combination therapy
Countries
Australia, Belgium, Spain