CompletedPhase 2

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

United States156 participantsStarted 2012-11-23

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Phase 1b: Number of Participants With Incidence of Dose Limiting Toxicities (DLTs): Cycle 1

Timeframe: Cycle 1: Day 1 to Day 28

Phase 2: Progression Free Survival (PFS)

Timeframe: From the date of randomization until the first documentation of disease progression or death due to any cause, censored date, whichever occurred first (maximum up to 43 months)

Trial details

NCT IDNCT01719380

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10-31

Results submitted2021-04-12

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