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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00478634 | A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal Cancer | PHASE1 | COMPLETED | 19 | — | — | May 1, 2007 | Sep 1, 2009 | Nov 2, 2012 | 16 | United States |
each cycle was 21 days
| Arm | Type | Description |
|---|---|---|
| A1: RAD001 + cetuximab + irinotecan | EXPERIMENTAL | RAD001 30mg weekly oral, 400mg/m2, loading i.v. (250mg/m2 for subsequent weekly dose i.v.), 350mg/m2 every 3 weeks i.v. |
| B1 dose: RAD001 + cetuximab + irinotecan | EXPERIMENTAL | RAD001 30mg weekly oral, 400mg/m2 loading i.v (250mg/m2 for subsequent weekly dose i.v.), 250mg/m2 every 3 weeks i.v. |
| Name | Type | Description |
|---|---|---|
| RAD001, Cetuximab, Irinotecan | DRUG | - |
Inclusion criteria: * Age ≥ 18 years old and ≤ 65 years old. * Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or cytological specimen from original resection of primary tumor. * Patients who progressed despite prior therapy with FOLFOX (5FU and oxaliplatin) plus bevaciz...