Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Gastrointestinal Malignancies
NCT ID: NCT01719380 (View complete trial on
DFCI Protocol ID: 12-432


This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Jason Faris, MD, Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Metastatic colorectal cancer - Progression after at least one prior standard of care regimen or be intolerant to irinotecan-based regimens - Life expectancy ≥ 3 months - ECOG performance status ≤ 2 Exclusion Criteria: - Symptomatic or untreated leptomeningeal disease - Symptomatic brain metastasis - Patients with clinically manifested diabetes - Acute or chronic pancreatitis - Clinically significant cardiac disease Other protocol-defined inclusion/exclusion criteria may apply.
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