Trials / Terminated
TerminatedNCT01493505
TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,015 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 386 | AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops) |
| DRUG | Paclitaxel | Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles) |
| DRUG | AMG 386 Placebo | AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops) |
| DRUG | Carboplatin | Carboplatin AUC 5 or 6 IV Q3W (6 cycles) |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2016-03-01
- Completion
- 2016-12-01
- First posted
- 2011-12-16
- Last updated
- 2017-02-23
Locations
310 sites across 14 countries: United States, Austria, Belgium, Canada, Denmark, Germany, Greece, Hong Kong, Italy, Japan, Netherlands, Russia, South Korea, Spain
Source: ClinicalTrials.gov record NCT01493505. Inclusion in this directory is not an endorsement.