Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.