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

Last updated: May 26, 2021
Sponsor: Pfizer
Overall Status: Completed

Phase

2

Condition

Colorectal Cancer

Colon Cancer

Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT01719380
CLGX818X2103
C4221002
2012-002138-35
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Metastatic colorectal cancer
  • Progression after at least one prior standard of care regimen or be intolerant toirinotecan-based regimens
  • Life expectancy ≥ 3 months
  • ECOG performance status ≤ 2

Exclusion

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.

Study Design

Total Participants: 156
Study Start date:
November 23, 2012
Estimated Completion Date:
February 12, 2019

Connect with a study center

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • UZ Gasthuisberg

    Leuven, Vlaams Brabant 3000
    Belgium

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Sir Mortimer B. Davis Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

    Montpellier, 34298
    France

    Site Not Available

  • Pfizer Investigative Site

    Montpellier Cedex 5, 34298
    France

    Site Not Available

  • Array BioPharma Investigative Site

    Saint Herblain cedex, 44805
    France

    Site Not Available

  • EDOG - Institut Claudius Regaud - PPDS

    Toulouse, 31052
    France

    Site Not Available

  • Novartis Investigative Site

    Toulouse Cedex 3, 31052
    France

    Site Not Available

  • Pfizer Investigative Site

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • University Hospital of Koln

    Köln, Nordrhein-westfalen 50937
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Array BioPharma Investigative Site

    Ancona, AN 60126
    Italy

    Site Not Available

  • Ospedaliero Universitaria di Modena Policlinico

    Modena, 41100
    Italy

    Site Not Available

  • Pharmacy of National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Pfizer Investigative Site

    Seoul, Korea 138-736
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center - PPDS

    Gangnam-Gu, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Asan Medical Center - PPDS

    Songpa-Gu, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, Noord-holland 1066 CX
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, Zuid-holland 3015 CE
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Oslo Myeloma Center - PPDS

    Oslo, 0379
    Norway

    Site Not Available

  • Array BioPharma Investigative Site

    Hospitalet de LLobregat, Catalunya 08907
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    a Gudiña, Ourense 32540
    Spain

    Site Not Available

  • Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28026
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio - PPDS

    Sevilla, 41013
    Spain

    Site Not Available

  • Keck Hospital of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • LAC&USC Medical Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCLA University of California Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Westwood Bowyer Clinic, Peter Morton Medical Building

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCLA Hematology Oncology

    Santa Monica, California 90404
    United States

    Site Not Available

  • UCLA Santa Monica Medical Center & Orthopaedic Hospital

    Santa Monica, California 90404
    United States

    Site Not Available

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Smilow Cancer Hospital Care Center at North Haven

    North Haven, Connecticut 06473
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114-2620
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10022
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10017-6706
    United States

    Site Not Available

  • Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept of Onc

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Dickson, Tennessee 37055
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee 37066
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee 37076
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee 37909
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee 37129
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Nashville, Tennessee 37207
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee 37160
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee 37167
    United States

    Site Not Available

  • Huntsman Cancer Hospital

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • John A Moran Eye Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Redwood Health Center - ARUP Lab Draw Location

    Salt Lake City, Utah 84119
    United States

    Site Not Available

  • University of Utah - Huntsman Cancer Institute - PPDS

    Salt Lake City, Utah 84112-5550
    United States

    Site Not Available

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