Trials / Terminated
TerminatedNCT00718523
Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer
A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 170 (actual)
- Sponsor
- Translational Research in Oncology · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (\<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 479 | Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle |
| DRUG | AMG 479 Placebo | Matching placebo administered Day 1 of each 21 day cycle. |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2013-09-01
- Completion
- 2014-11-01
- First posted
- 2008-07-18
- Last updated
- 2016-01-12
- Results posted
- 2016-01-12
Locations
55 sites across 8 countries: United States, Canada, France, Germany, Ireland, Israel, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00718523. Inclusion in this directory is not an endorsement.