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Study of LGX818 and Cetuximab...

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

NCT ID: NCT01719380

Last Updated: 2021-06-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-23

Study Completion Date

2019-02-12

Brief Summary

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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

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LGX818 + cetuximab

Group Type EXPERIMENTAL

LGX818

Intervention Type DRUG

Cetuximab

Intervention Type DRUG

LGX818 + BYL719 + cetuximab

Group Type EXPERIMENTAL

LGX818

Intervention Type DRUG

Cetuximab

Intervention Type DRUG

BYL719

Intervention Type DRUG

Interventions

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LGX818

Intervention Type DRUG

Cetuximab

Intervention Type DRUG

BYL719

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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