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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01113957 | A Trial of ABT-888 in Combination With Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Ovarian Cancer | PHASE2 | COMPLETED | 168 | — | — | Mar 1, 2010 | Jun 1, 2013 | Jun 6, 2018 | 32 | United States, Australia +6 |
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | ABT-888 in combination with temozolomide |
| Arm B | ACTIVE_COMPARATOR | pegylated liposomal doxorubicin alone |
| Name | Type | Description |
|---|---|---|
| ABT-888 | DRUG | Arm-A subjects will be given ABT-888 on Days 1 -7 every 28 days orally |
| pegylated liposomal doxorubicin | DRUG | Arm B subjects randomized to pegylated liposomal doxorubicin on Day 1, every 28 days intravenously. |
| temozolomide | DRUG | Arm A subjects will be given temozolomide on days 1-5 every 28 days orally with ABT-888 |
Inclusion Criteria: * Subject must have histologically (or cytologically) confirmed recurrent high grade serous ovarian, fallopian tube, or primary peritoneal cancer. * Subjects must have had at least 1 platinum containing chemotherapy regimen and no more than a total of 3 DNA damaging or cytotoxic...