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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00422682 | A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors | PHASE1 | COMPLETED | 136 | — | — | Jan 1, 2007 | Oct 1, 2012 | Jun 10, 2016 | 6 | United States |
| NCT00298675 | Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors | PHASE1 | COMPLETED | 59 | — | — | Mar 1, 2006 | May 1, 2011 | Aug 2, 2012 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | BSI-201 + topotecan |
| 2 | EXPERIMENTAL | BSI-201 + temozolomide |
| 3 | EXPERIMENTAL | bsi-201 + gemcitabine |
| 4 | EXPERIMENTAL | bsi-201 + carboplatin/paclitaxel |
| Iniparib | EXPERIMENTAL | - |
| Iniparib/irinotecan | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| bsi-201 + topotecan | DRUG | 21 day cycle |
| bsi-201 + temozolomide | DRUG | 28 day cycle |
| bsi-201 + gemcitabine | DRUG | 28 day cycle |
| bsi-201 + carboplatin/paclitaxel | DRUG | 21 day cycle |
| BSI-201 (iniparib) | DRUG | BSI-201 administered intravenously (IV), 2x weekly |
| irinotecan | DRUG | Irinotecan administered weekly, IV. |
Inclusion Criteria: * ≥ 18 years old with a histologically or cytologically documented, advanced solid tumor * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (without granulocyte colony-stimulating factor \[G-CSF\] support withi...