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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00494442 | Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer | PHASE2 | COMPLETED | 58 | — | — | Jun 11, 2007 | Jul 20, 2017 | Aug 1, 2018 | 11 | United States, Australia +3 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| KU-0059436 (AZD2281) 100 mg BID | EXPERIMENTAL | - |
| KU-0059436 (AZD2281) 400 mg BID | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| KU-0059436 (AZD2281)(PARP inhibitor) | DRUG | oral |
Inclusion Criteria: * Advanced ovarian cancer with positive BRCA1 or BRCA2 status * Failed at least one prior chemotherapy * In investigators opinion, no curative standard therapy exists * Measurable disease Exclusion Criteria: * Brain metastases * Less than 28 days since last treatment used to t...