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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Cetuximab; Drug: LGX818; Drug: BYL719

Study type: Interventional

Funder types: Industry

Identifiers

NCT01719380

2012-002138-35 (EudraCT Number)

CLGX818X2103

C4221002 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

LGX818 + cetuximab

Experimental group

Treatment:

Drug: Cetuximab

Drug: LGX818

LGX818 + BYL719 + cetuximab

Experimental group

Treatment:

Drug: BYL719

Drug: Cetuximab

Drug: LGX818