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

• Status: Completed
• Trial end date: 2019-02-12
• Target enrollment: 0
• Participant gender: All

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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Array BioPharma; Pfizer
• Treatments: Cetuximab

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.