Trials / Completed
CompletedNCT01253681
Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian Cancer
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 386, paclitaxel and carboplatin | 15 mg/Kg AMG 386 IV (intravenous) weekly plus paclitaxel and carboplatin IV Q3W for 18 weeks, followed by 15mg/Kg AMG 386 IV (intravenous) weekly alone for an additional 18 months. |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2012-10-01
- Completion
- 2015-01-01
- First posted
- 2010-12-03
- Last updated
- 2015-10-14
Locations
8 sites across 3 countries: Australia, Belgium, Spain
Source: ClinicalTrials.gov record NCT01253681. Inclusion in this directory is not an endorsement.