Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01204749 | TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer | PHASE3 | COMPLETED | 919 | — | — | Nov 1, 2010 | Dec 1, 2016 | Dec 15, 2016 | 225 | United States, Australia +30 |
| Arm | Type | Description |
|---|---|---|
| AMG 386 | EXPERIMENTAL | Arm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW |
| AMG 386 Placebo | PLACEBO_COMPARATOR | Arm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW |
| Name | Type | Description |
|---|---|---|
| AMG 386 | DRUG | Weekly Intravenous (IV) AMG 386 15 mg/kg |
| AMG 386 Placebo | DRUG | Weekly Intravenous (IV) placebo 15 mg/kg |
| Paclitaxel | DRUG | Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off) |
Inclusion Criteria: * Female 18 years of age or older at the time the written informed consent is obtained * Gynecologic Oncology Group (GOG) Performance Status of 0 or 1 * Life expectancy \>= 3 months (per investigator opinion) * Histologically or cytologically documented invasive epithelial ovari...