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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00457691 | Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer | PHASE3 | COMPLETED | 768 | — | — | Jun 1, 2007 | Mar 1, 2010 | Mar 30, 2015 | 132 | Argentina, Australia +32 |
PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 5 fluorouracil | DRUG | 400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days |
| irinotecan | DRUG | 180mg/m2 iv day 1 every 14 days |
| levo- leucovorin | DRUG | 200mg/m2 iv; day 1 every 14 days |
| sunitinib | DRUG | 37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period |
| placebo | DRUG | 37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period |
Inclusion Criteria: * Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease. * Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated. * Adequate organ function defined by blood test. Exclusion ...