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

Completed · Phase 2

Conditions studied: Colorectal Cancer

In brief

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

Key facts

Study ID

NCT01719380

Run by

Pfizer

People needed

156

Starts

2012-11-23

Expected to finish

2019-02-12

Last updated by the study team

2021-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• LAC&USC Medical Center — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA University of California Los Angeles — Los Angeles, California, United States
• Westwood Bowyer Clinic, Peter Morton Medical Building — Los Angeles, California, United States
• UCLA Hematology Oncology — Santa Monica, California, United States
• UCLA Santa Monica Medical Center & Orthopaedic Hospital — Santa Monica, California, United States
• Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Smilow Cancer Hospital Care Center at North Haven — North Haven, Connecticut, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Tennessee Oncology, PLLC — Dickson, Tennessee, United States
• Tennessee Oncology, PLLC — Franklin, Tennessee, United States
• Tennessee Oncology, PLLC — Gallatin, Tennessee, United States
• Tennessee Oncology, PLLC — Hermitage, Tennessee, United States
• Tennessee Oncology, PLLC — Lebanon, Tennessee, United States
• Tennessee Oncology, PLLC — Murfreesboro, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• Keck Hospital of USC — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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