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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00835185 | Study of IMC-11F8 in Participants With Colorectal Cancer | PHASE2 | COMPLETED | 44 | — | — | Aug 1, 2007 | Oct 1, 2010 | Jan 29, 2016 | 5 | Belgium, Spain |
CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) \* 100.
| Arm | Type | Description |
|---|---|---|
| IMC-11F8 (necitumumab) /mFOLFOX-6 regimen | EXPERIMENTAL | Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) |
| Name | Type | Description |
|---|---|---|
| IMC-11F8 (necitumumab) | BIOLOGICAL | IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1 |
| Oxaliplatin | DRUG | Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1 |
| Folinic acid (FA) | DRUG | FA 400 mg/m² IV infusion bolus injection |
| 5-FU | DRUG | 5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours |
Inclusion Criteria: * Histologically-confirmed, EGFR-detectable or EGFR-undetectable CRC * Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum * At least 1 unidimensional-measurable target lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI); tar...