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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01193140 | To Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors | PHASE2 | COMPLETED | 24 | — | — | Jul 1, 2010 | Nov 1, 2011 | Nov 21, 2012 | 2 | United States |
Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| veliparib | DRUG | Dose orally twice daily for 7 days, consecutively, every cycle |
| Temozolomide | DRUG | Dose orally once daily for 5 days, consecutively, every cycle |
Inclusion Criteria 1. Subject has completed study participation in Study M11-846 2. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2. 3. Subject must have adequate hematologic, renal and hepatic function per institutional normal range as follows: • Bone Marrow: Absolute neutrop...