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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00460603 | Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer | PHASE1 | COMPLETED | 187 | — | — | Jan 1, 2006 | Nov 1, 2012 | Dec 6, 2013 | 106 | United States |
Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as \>=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study \>=4 weeks after initial documentation of response.
| Arm | Type | Description |
|---|---|---|
| B | ACTIVE_COMPARATOR | bevacizumab 5 mg/kg every 2 weeks + FOLFOX |
| C | EXPERIMENTAL | AG-013726 5 mg bid+ bevacizumab 2 mg/kg every 2 weeks + FOLFOX |
| A | EXPERIMENTAL | AG-013736 5 mg bid starting dose + FOLFOX |
| Name | Type | Description |
|---|---|---|
| bevacizumab | DRUG | bevacizumab 5 mg/kg every 2 weeks |
| AG-013726 | DRUG | AG-013726 5 mg bid every 2 weeks |
| AG-013736 (axitinib) | DRUG | AG-013736 5 mg bid starting dose |
Inclusion Criteria: * (Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous chemotherapy for greater than 3 months prior to enrollment * (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC) previously untreated with any systemic therapy. * Patient...