Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Last updated: May 11, 2020
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

3

Condition

Gastric Ulcers

Stomach Cancer

Adenocarcinoma

Treatment

5-fluorouracil

Placebo

Oxaliplatin

Clinical Study ID

NCT02545504
GS-US-296-1080
2015-001526-42
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Adults with histologically confirmed adenocarcinoma of the stomach or gastroesophagealjunction that is inoperable, locally advanced or metastatic and not amenable tocurative therapy

  • Adequate hematologic, liver, coagulation and kidney function

  • Eastern Cooperative Oncology Group (ECOG) ≤ 1

  • Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1

Exclusion

Key Exclusion Criteria:

  • Previous chemotherapy for locally advanced or metastatic gastric cancer.

  • Human Epidermal Growth Factor Receptor 2 (HER2)-positive gastric cancer

  • HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection

  • Pregnant or breast feeding women

  • Individuals with known or suspected central nervous system metastases or individualsrequiring chronic daily treatment with oral corticosteroids

  • Grade ≥ 2 peripheral neuropathy Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 432
Treatment Group(s): 5
Primary Treatment: 5-fluorouracil
Phase: 3
Study Start date:
October 13, 2015
Estimated Completion Date:
May 15, 2019

Connect with a study center

  • The Canberra Hospital

    Garran, Australian Capital Territory
    Australia

    Site Not Available

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales
    Australia

    Site Not Available

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales
    Australia

    Site Not Available

  • The Crown Princess Mary Cancer Centre

    Westmead, New South Wales
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Brisbane, Queensland
    Australia

    Site Not Available

  • Townsville Cancer Center

    Douglas, Queensland
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba Brisbane, Queensland
    Australia

    Site Not Available

  • Ashford Cancer Centre

    Kurralta Park, South Australia
    Australia

    Site Not Available

  • Royal Hobart Hospital

    Hobart, Tasmania
    Australia

    Site Not Available

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria
    Australia

    Site Not Available

  • Cabrini Health - Cabrini Hospital Malvern

    Malvern, Victoria
    Australia

    Site Not Available

  • Epworth Healthcare

    Richmond, Victoria
    Australia

    Site Not Available

  • Western Health Sunshine Hospital

    St Albans, Victoria
    Australia

    Site Not Available

  • The Tweed Hospital

    Tweed Heads, 2485
    Australia

    Site Not Available

  • Sydney Adventist Hospital

    Wahroonga,
    Australia

    Site Not Available

  • Border Medical Oncology Research

    Wodonga,
    Australia

    Site Not Available

  • Centre Hospitalizer De L'Ardenne

    Libramont, Chevigny
    Belgium

    Site Not Available

  • University Hospital Antwerp

    Edegem,
    Belgium

    Site Not Available

  • University Hospital Gent Department of Gastroenterology

    Gent,
    Belgium

    Site Not Available

  • Centre Hospitalier de Jolimont-Lobbes

    Haine-Saint-Paul,
    Belgium

    Site Not Available

  • Centre Hospitalizer De L'Ardenne

    Libramont-Chevigny,
    Belgium

    Site Not Available

  • Centro Internacional de Estudios Clinicos (CIEC)

    Recoleta, Santiago
    Chile

    Site Not Available

  • Instituto Nacional Del Cancer

    Santiago,
    Chile

    Site Not Available

  • Instituto Clinico Oncologico del Sur

    Temuco,
    Chile

    Site Not Available

  • Hospital Clinico Vina Del Mar

    Vina del Mar,
    Chile

    Site Not Available

  • Oncomedica S.A

    Monteria, Cordoba
    Colombia

    Site Not Available

  • Dundacion Oftalmologica de Santander Clinica Ardila Lulle La Foscal

    Floridablanca,
    Colombia

    Site Not Available

  • Hospital Pablo Tobon Uribe

    Medellin,
    Colombia

    Site Not Available

  • Centro Medico Imbanaco de Cali S.A

    Valle,
    Colombia

    Site Not Available

  • Centro Medico Imbanaco de Cali S.A

    Valle del Cauca,
    Colombia

    Site Not Available

  • Comprehensive Cancer Center Regional Hospital Liberec

    Liberec 1,
    Czech Republic

    Site Not Available

  • Hospital Na Bulovce-University Hospital Na Bulovce

    Prague 8,
    Czech Republic

    Site Not Available

  • Fakultni Nemocnice Brno

    Brno,
    Czechia

    Site Not Available

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove,
    Czechia

    Site Not Available

  • University Hospital - Czech

    Olomouc,
    Czechia

    Site Not Available

  • Thomayer Hospital

    Prague 4,
    Czechia

    Site Not Available

  • Oblastni Nemocnice Pribram

    Pribram,
    Czechia

    Site Not Available

  • CH Annecy-Gennevois

    Tessy, Pringy Cedex
    France

    Site Not Available

  • CHU Jean Minjoz

    Besancon,
    France

    Site Not Available

  • Hopital Avicenne

    Bobigny,
    France

    Site Not Available

  • CHRU de Brest, Hopital Morvan, Institut de Cancerologie et d'Hematologie

    Brest Cedex,
    France

    Site Not Available

  • Hôpitaux Civils de Colmar

    Colmar,
    France

    Site Not Available

  • Polyclinique de Blois

    La Chaussee st Victor,
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille Cedex 9,
    France

    Site Not Available

  • CHU de Nice-l Archet

    Nice Cedex 3,
    France

    Site Not Available

  • CH Annecy-Gennevois

    Pringy Cedex,
    France

    Site Not Available

  • Hopital Civil

    Strasbourg Cedex,
    France

    Site Not Available

  • Kliniken Nordoberpfalz AG

    Weiden, Bavaria
    Germany

    Site Not Available

  • Kliniken Nordoberpfalz AG

    Weiden i.d. Oberpfalz, Bavaria
    Germany

    Site Not Available

  • Klinikum rechts der Isar Technical University of Ismaninger

    Munich, Bayern
    Germany

    Site Not Available

  • DRK Klinken Berlin Abteilungsleiter Chiurgische Okologie

    Berlin,
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus

    Dresden,
    Germany

    Site Not Available

  • Kliniken Essen Mitte Studiensekretariat Onkologie Evang. Huyssens-Stiftung

    Essen,
    Germany

    Site Not Available

  • Krankenhaus Nordwest gGmbH Institut für Klinisch Onkologische Med Klinik II

    Frankfurt,
    Germany

    Site Not Available

  • Cancer Center Heilbronn-Franken, SLK-Kliniken

    Heilbronn,
    Germany

    Site Not Available

  • Staedtisches Klinikum Muenchen Bogenhausen

    Muenchen,
    Germany

    Site Not Available

  • Zentrum fur Innere Medizin Stauferklinikum Schwab

    Mutlangen,
    Germany

    Site Not Available

  • ABAG MVZ

    Saxonia,
    Germany

    Site Not Available

  • Universitatsklinikum Ulm

    Ulm,
    Germany

    Site Not Available

  • Egyesített Szent István és Szent László Kórház -Rendelőintézet

    Budapest,
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Központ

    Debrecen,
    Hungary

    Site Not Available

  • Human Klinikai Vizsgalatok Regisztracios Kozpont - HKVRK

    Gyor,
    Hungary

    Site Not Available

  • Pandy Kalman Hospital

    Gyula,
    Hungary

    Site Not Available

  • Borsod County Hospital Clinical Oncological and Radiotheraputic Center

    Miskolc,
    Hungary

    Site Not Available

  • Zala Megyei Korhaz Pozva Diabetes Kulsokorhaz

    Zalaegerszeg,
    Hungary

    Site Not Available

  • University Hospital Company of Pisana

    Pisa, PI
    Italy

    Site Not Available

  • Policlinico S.Orsola-Malpighi

    Bologna,
    Italy

    Site Not Available

  • Foundazione Poliambulanza Istituto Ospedaliero UO Cardiologia

    Brescia,
    Italy

    Site Not Available

  • Ircc Istituto Per La Ricera E La Cura Del Cancro Di Candiolo Oncologia Medica

    Candiolo,
    Italy

    Site Not Available

  • Ente Ospedaliero Ospedali Galliera

    Genova,
    Italy

    Site Not Available

  • IRCCS A.O.U. San Martino

    Genova,
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano,
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano,
    Italy

    Site Not Available

  • S.C. Oncologia Medica Azienda Ospedaliera Valtellina e Valchiavenna Presidio Ospedaliero di Sondrio

    Sondrio,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette

    Torino,
    Italy

    Site Not Available

  • Azienda Ospedaliera Treviglio Caravaggio U.O. Oncologia Medica

    Treviglio,
    Italy

    Site Not Available

  • Auna Oncosalud

    San Borja, Lima
    Peru

    Site Not Available

  • Centro de Investigacion Instituto de oncologia y Radiotherpia de la Clinica

    San Isidro, Lima
    Peru

    Site Not Available

  • Centro Medico monte Carmelo

    Arequipa,
    Peru

    Site Not Available

  • Clinica Anglo Americana Calle Alfredo Salazar

    San Isidro,
    Peru

    Site Not Available

  • Centro de Investigacion Clinica Trujillo EIRL

    Trujillo,
    Peru

    Site Not Available

  • Beskidzkie Oncology Center

    Bielsko-Biala,
    Poland

    Site Not Available

  • Wojewodzki Szpital Zespolony w Elblagu Oddzial Onkologiczny

    Elblag,
    Poland

    Site Not Available

  • Wojewodzkie Centrum Okologii w Gdansku Sp Zo.o

    Gdansk,
    Poland

    Site Not Available

  • Wielkopolskie Centrum Onkologii

    Poznan,
    Poland

    Site Not Available

  • Mrukmed Lekarz Beata Madej Mruk i Partner Spolka Partnerska Oddzial Nr 1 w Rzeszowie

    Rzeszow,
    Poland

    Site Not Available

  • Mrukmed Lekarz Beata Madej Mruk i Partner Spolka Partnerska Oddzial Nr 1 w Rzeszowie

    Rzeszáw,
    Poland

    Site Not Available

  • Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu

    Torun,
    Poland

    Site Not Available

  • Wojskowy Instytut Medyczny

    Warsaw,
    Poland

    Site Not Available

  • Klinka Gastroenterologii Okologicznej Centrum Okologii Instytut

    Warszawa,
    Poland

    Site Not Available

  • Medisprof srl Oncologie P TA

    Cluj-Napoca, Judet Cluj
    Romania

    Site Not Available

  • SC Centrul de Oncologie Euroclinic SRL, Oncologie

    Lasi, Judet Lasi
    Romania

    Site Not Available

  • Fundeni Clinical Institute

    Bucuresti,
    Romania

    Site Not Available

  • GRAL Medical SRL

    Bucuresti,
    Romania

    Site Not Available

  • Centrul de Oncologie Sfantul Nectarie SRL, Oncologie

    Craiova,
    Romania

    Site Not Available

  • Sc Oncolab Srl

    Craiova,
    Romania

    Site Not Available

  • SC Centrul de Oncologie Euroclinic SRL, Oncologie

    Iaşi,
    Romania

    Site Not Available

  • Spitalul Judetean De Urgenta Sf Ion Cel Nou Suceava Sectia Oncologie Medicala Bdul

    Suceava,
    Romania

    Site Not Available

  • Hospital Universitario de A Coruna C

    A Coruna,
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Hospital Del Mar Servicio de Oncologia

    Barcelona,
    Spain

    Site Not Available

  • Hospital Parc Tauli

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona,
    Spain

    Site Not Available

  • Institut Catala de la Salut

    Barcelona,
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid,
    Spain

    Site Not Available

  • Hospital Ramon y Cajal

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Majadahonda Madrid,
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga

    Malaga,
    Spain

    Site Not Available

  • Hospital Universitario Morales Meseguer

    Murcia,
    Spain

    Site Not Available

  • Complejo Hospitalario de Navarra

    Pamplona,
    Spain

    Site Not Available

  • Complejo Hospitalario de Navarra

    Pamplona Navarra,
    Spain

    Site Not Available

  • Hospital Parc Tauli

    Sabadell Barcelona,
    Spain

    Site Not Available

  • Hospital Virgen de Valme

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza,
    Spain

    Site Not Available

  • Cukurova Universitesi

    Adana,
    Turkey

    Site Not Available

  • Ankara University Medical Faculty Ibni Sina Hospital

    Ankara,
    Turkey

    Site Not Available

  • Hacettepe Universitesi Tip Facultesi Cocuk Saligi ve Hastaklikleri Anabilim Dali

    Ankara,
    Turkey

    Site Not Available

  • Hacettepe University

    Ankara,
    Turkey

    Site Not Available

  • University of Uludag

    Bursa,
    Turkey

    Site Not Available

  • Trakya University

    Edirne,
    Turkey

    Site Not Available

  • Bezmialem University Hospital

    Istanbul,
    Turkey

    Site Not Available

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Istanbul,
    Turkey

    Site Not Available

  • Istanbul Universitesi Onkoloji Enstitusu Medikal Onkoloji Bilim Dali

    Istanbul,
    Turkey

    Site Not Available

  • Marmara University

    Kadikoy,
    Turkey

    Site Not Available

  • Izmir Universitesi Hastanesi Yeni Girne Vulvari

    Karsiyaka,
    Turkey

    Site Not Available

  • Kocaeli Universty

    Kocaeli,
    Turkey

    Site Not Available

  • Inonu Universitesi Turgut Ozal Tip Merkezi Elazi

    Malatya,
    Turkey

    Site Not Available

  • Van Yuzuncu Yil Universitesi Tip Kaultesi Ic Hastaliklari Anabilim Dali Tibbi Okoloji Bilim Dali

    Van,
    Turkey

    Site Not Available

  • New Queen Elizabeth Hospital

    Birmingham,
    United Kingdom

    Site Not Available

  • Peterborough City Hospital Peterborough and Stamford Hospitals NHS Foundation Trust

    Cambridge,
    United Kingdom

    Site Not Available

  • Peterborough City Hospital Peterborough and Stamford Hospitals NHS Foundation Trust

    Cambridgeshire,
    United Kingdom

    Site Not Available

  • New Queen Elizabeth Hospital

    Edgbaston Birmingham,
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital Mulberry House

    London,
    United Kingdom

    Site Not Available

  • University College London

    London,
    United Kingdom

    Site Not Available

  • Christie Hospital NHS Foundation Trust

    Manchester,
    United Kingdom

    Site Not Available

  • York Teaching Hospital NHS Foundation Trust

    York,
    United Kingdom

    Site Not Available

  • Arizona Oncology Associates

    Tucson, Arizona
    United States

    Site Not Available

  • Scripps Green Hospital

    La Jolla, California 92037
    United States

    Site Not Available

  • UCLA Jonsson Comprehensive Cancer Center

    Los Angeles, California 90024
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90007
    United States

    Site Not Available

  • Innovative Clinical Research Institute

    Whittier, California 90603
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers

    Denver, Colorado
    United States

    Site Not Available

  • Cancer Center of Central Connecticut

    Plainville, Connecticut 06062
    United States

    Site Not Available

  • Omega Research Consultants LLC

    DeBary, Florida 32713
    United States

    Site Not Available

  • Illinois Cancer Specialists

    Arlington Heights, Illinois
    United States

    Site Not Available

  • Inglalls Memorial Hospital

    Harvey, Illinois
    United States

    Site Not Available

  • Edward Hospital & Health Services

    Naperville, Illinois 60540
    United States

    Site Not Available

  • Parkview Hospital

    Fort Wayne, Indiana 46805
    United States

    Site Not Available

  • Indiana University Goshen Center for Cancer Care

    Goshen, Indiana 46526
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70816
    United States

    Site Not Available

  • New England Cancer Specialists

    Scarborough, Maine 04074
    United States

    Site Not Available

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland
    United States

    Site Not Available

  • Karamanos Cancer Institute

    Detroit, Michigan 48175
    United States

    Site Not Available

  • HCA Healthcare

    Kansas City, Missouri 64030
    United States

    Site Not Available

  • Saint Louis University

    St. Louis, Missouri
    United States

    Site Not Available

  • Oncology Hematology West, P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska
    United States

    Site Not Available

  • Carol G. Simon Cancer Center

    Morristown, New Jersey 07901
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune, New Jersey
    United States

    Site Not Available

  • Regional Cancer Care Associates LLC - Sparta

    Sparta, New Jersey 07871
    United States

    Site Not Available

  • Broome Oncology, LLC

    Johnson City, New York
    United States

    Site Not Available

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York 10065
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14627
    United States

    Site Not Available

  • Duke Cancer Institute

    Durham, North Carolina 27710
    United States

    Site Not Available

  • First Health of the Carolinas

    Pinehurst, North Carolina
    United States

    Site Not Available

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • The Ohio State Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Northwest Cancer Specialists

    Portland, Oregon 97213
    United States

    Site Not Available

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina 29403
    United States

    Site Not Available

  • Greenville Health System

    Greenville, South Carolina
    United States

    Site Not Available

  • Prairie Lakes Health Care System INC

    Watertown, South Dakota
    United States

    Site Not Available

  • Tennessee Oncology

    Chattanooga, Tennessee
    United States

    Site Not Available

  • Tennessee Cancer Specialists Center for Biomedical Research

    Knoxville, Tennessee
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee
    United States

    Site Not Available

  • Texas Health Physicians Group

    Arlington, Texas
    United States

    Site Not Available

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas
    United States

    Site Not Available

  • Texas Oncology PA

    Denton, Texas
    United States

    Site Not Available

  • Center for Cancer Blood Disorders

    Fort Worth, Texas
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas
    United States

    Site Not Available

  • Texas Oncology-Mcallen South Second

    Mcallen, Texas
    United States

    Site Not Available

  • Texas Oncology-Midland Allison Cancer Center, Craddick Medical Office Building

    Midland, Texas
    United States

    Site Not Available

  • Texas Oncology-Plano East

    Plano, Texas
    United States

    Site Not Available

  • Texas Oncology-Seton Williamson

    Round Rock, Texas
    United States

    Site Not Available

  • Texas Oncology-Sugarland

    Sugar Land, Texas
    United States

    Site Not Available

  • Scott and White Memorial Hospital

    Temple, Texas
    United States

    Site Not Available

  • Texas Oncology-Tyler

    Tyler, Texas
    United States

    Site Not Available

  • Utah Cancer Specialists

    Salt Lake City, Utah
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia
    United States

    Site Not Available

  • Virginia Mason Seattle Main Clinic

    Seattle, Washington
    United States

    Site Not Available

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