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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01086267 | Safety and Efficacy Study of BMS-908662 Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer | PHASE1 | COMPLETED | 17 | — | — | Jul 1, 2010 | Aug 1, 2011 | Jun 27, 2016 | 3 | United States, Canada |
| Arm | Type | Description |
|---|---|---|
| BMS-908662 (A1) | EXPERIMENTAL | Phase 1 |
| Cetuximab (A1) | EXPERIMENTAL | Phase 1 |
| BMS-908662 (B1) | EXPERIMENTAL | Phase 2 |
| BMS-908662 + Cetuximab (B2) | EXPERIMENTAL | Phase 2 |
| Name | Type | Description |
|---|---|---|
| BMS-908662 | DRUG | Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously |
| Cetuximab | DRUG | Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously |
Inclusion Criteria: * Subjects with K-RAS (codon 12 or 13) or B -RAF (V600E) mutation positive advanced or metastatic colorectal cancer who have relapsed or are refractory to 2 or more standard systemic anticancer regimes for metastatic disease, or are intolerant to existing therapies. * Histologic...