A Phase Ib/II Multi-center, Open-label, Dose Escalation Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in Patients With BRAF Mutant Metastatic Colorectal Cancer
Description
Brief Summary
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
Phase
Phase 1/2 - for trials that are a combination of phases 1 and 2.Inclusion and Exclusion 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
- 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.
Sites
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California
- USC/Kenneth Norris Comprehensive Cancer Center USC 2, Los Angeles, California, 90033
- USC/Kenneth Norris Comprehensive Cancer Center USC 2, Los Angeles, California, 90033
- University of California at Los Angeles Dept. of UCLA, Los Angeles, California, 90095
- University of California at Los Angeles Dept. of UCLA, Los Angeles, California, 90095
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Utah
- University of Utah / Huntsman Cancer Institute Onc Dept, Salt Lake City, Utah, 84103
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Tennessee
- Sarah Cannon Research Institute SCRI SC, Nashville, Tennessee, 37203
- Sarah Cannon Research Institute SCRI SC, Nashville, Tennessee, 37203
- Vanderbilt University Medical Center SC-5, Nashville, Tennessee, 37232
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AN
- Novartis Investigative Site, Ancona, AN, 60126
- Novartis Investigative Site, Ancona, AN, 60126
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Germany
- Novartis Investigative Site, Essen, 45147
- Novartis Investigative Site, Essen, 45147
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