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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00813605 | QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma | PHASE2 | COMPLETED | 155 | — | — | Mar 1, 2009 | Jun 1, 2012 | Oct 27, 2016 | 67 | United States, France +8 |
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days |
| Arm C | ACTIVE_COMPARATOR | AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days |
| Arm B | EXPERIMENTAL | AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days |
| Name | Type | Description |
|---|---|---|
| FOLFIRI | OTHER | Day 1 of each Cycle Combination Therapy of: irinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion |
| AMG 655 | BIOLOGICAL | AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5) |
| Placebo | OTHER | Inactive dummy agent (to maintain blind) |
| AMG 479 | BIOLOGICAL | AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1 |
Inclusion Criteria: * Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease * Mutant-type KRAS tumor at screening * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1 * Adequate hematology, renal, hepatic, and coagulation function Exclusi...