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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02613650 | A Trial of mFOLFIRI With MEK162 in Patients With Advanced RAS (HRAS, NRAS, or KRAS) Positive Metastatic Colorectal Cancers | PHASE1 | COMPLETED | 25 | — | — | Aug 19, 2016 | Dec 21, 2022 | May 12, 2026 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| MEK162 and mFOLFIRI, all patients | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MEK162 and mFOLFIRI | DRUG | MEK162 in combination with mFOLFIRI in a 14 day cycle MEK162 will be given single agent 6 day lead in and then will be given in combination with mFOLFIRI mFOLFIRI Administered Day 1 of each cycle Irinotecan 180mg/m2 iv over 90 minutes on day 1 5-fluoruracil 1200mg/m2 continuous infusion for 48 hours (2400mg/m2 in 48 hours) Followed by MEK162 - Taken twice daily orally on Days 1-12 of each cycle Level -1: mFOLFIRI at 80% + MEK162 30 mg twice daily 1 week on and 1 week off Level 1: mFOLFIRI + MEK162 30 mg twice daily Level 2: mFOLFIRI + MEK162 45 mg twice daily |
Inclusion Criteria: * Age \> 18 years old * Patients with histologically confirmed RAS (HRAS, NRAS, or KRAS) positive metastatic colorectal cancer. * Patients must have progressed during or after first-line treatment for metastatic disease with oxaliplatin and fluoropyrimidines based chemotherapy (...