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Brief Title: Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined With mFOLFOX6 as First Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Study ID: NCT02545504
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Scripps Green Hospital, La Jolla, California, United States
University of Southern California, Los Angeles, California, United States
UCLA Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
Cancer Center of Central Connecticut, Plainville, Connecticut, United States
Omega Research Consultants LLC, DeBary, Florida, United States
Edward Hospital & Health Services, Naperville, Illinois, United States
Parkview Hospital, Fort Wayne, Indiana, United States
Indiana University Goshen Center for Cancer Care, Goshen, Indiana, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
New England Cancer Specialists, Scarborough, Maine, United States
Karamanos Cancer Institute, Detroit, Michigan, United States
HCA Healthcare, Kansas City, Missouri, United States
Carol G. Simon Cancer Center, Morristown, New Jersey, United States
Regional Cancer Care Associates LLC - Sparta, Sparta, New Jersey, United States
Weill Cornell Medical College - New York Presbyterian Hospital, New York, New York, United States
University of Rochester, Rochester, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
The Ohio State Medical Center, Columbus, Ohio, United States
Northwest Cancer Specialists, Portland, Oregon, United States
Charleston Hematology Oncology Associates, Charleston, South Carolina, United States
Prairie Lakes Health Care System INC, Watertown, South Dakota, United States
Tennessee Oncology, Nashville, Tennessee, United States
Center for Cancer Blood Disorders, Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Texas Oncology-Seton Williamson, Round Rock, Texas, United States
Scott and White Memorial Hospital, Temple, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Virginia Mason Seattle Main Clinic, Seattle, Washington, United States
The Canberra Hospital, Garran, Australian Capital Territory, Australia
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
The Crown Princess Mary Cancer Centre, Westmead, New South Wales, Australia
Princess Alexandra Hospital, Brisbane, Queensland, Australia
Ashford Cancer Centre, Kurralta Park, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Epworth Healthcare, Richmond, Victoria, Australia
Western Health Sunshine Hospital, St Albans, Victoria, Australia
The Tweed Hospital, Tweed Heads, , Australia
Sydney Adventist Hospital, Wahroonga, , Australia
Centre Hospitalizer De L'Ardenne, Libramont, Chevigny, Belgium
University Hospital Gent Department of Gastroenterology, Gent, , Belgium
Instituto Nacional Del Cancer, Santiago, , Chile
Instituto Clinico Oncologico del Sur, Temuco, , Chile
Hospital Clinico Vina Del Mar, Vina del Mar, , Chile
Oncomedica S.A, Monteria, Cordoba, Colombia
Dundacion Oftalmologica de Santander Clinica Ardila Lulle La Foscal, Floridablanca, , Colombia
Hospital Pablo Tobon Uribe, Medellin, , Colombia
Centro Medico Imbanaco de Cali S.A, Valle, , Colombia
Fakultni Nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
University Hospital - Czech, Olomouc, , Czechia
Thomayer Hospital, Prague 4, , Czechia
Oblastni Nemocnice Pribram, Pribram, , Czechia
CHU Jean Minjoz, Besancon, , France
CHRU de Brest, Hopital Morvan, Institut de Cancerologie et d'Hematologie, Brest Cedex, , France
Hôpitaux Civils de Colmar, Colmar, , France
Institut Paoli Calmettes, Marseille Cedex 9, , France
CHU de Nice-l Archet, Nice Cedex 3, , France
CH Annecy-Gennevois, Pringy Cedex, , France
Kliniken Nordoberpfalz AG, Weiden, Bavaria, Germany
Klinikum rechts der Isar Technical University of Ismaninger, Munich, Bayern, Germany
DRK Klinken Berlin Abteilungsleiter Chiurgische Okologie, Berlin, , Germany
Universitätsklinikum Carl Gustav Carus, Dresden, , Germany
Kliniken Essen Mitte Studiensekretariat Onkologie Evang. Huyssens-Stiftung, Essen, , Germany
Krankenhaus Nordwest gGmbH Institut für Klinisch Onkologische Med Klinik II, Frankfurt, , Germany
Cancer Center Heilbronn-Franken, SLK-Kliniken, Heilbronn, , Germany
Staedtisches Klinikum Muenchen Bogenhausen, Muenchen, , Germany
Zentrum fur Innere Medizin Stauferklinikum Schwab, Mutlangen, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Egyesített Szent István és Szent László Kórház -Rendelőintézet, Budapest, , Hungary
Debreceni Egyetem Klinikai Központ, Debrecen, , Hungary
Human Klinikai Vizsgalatok Regisztracios Kozpont - HKVRK, Gyor, , Hungary
Pandy Kalman Hospital, Gyula, , Hungary
Borsod County Hospital Clinical Oncological and Radiotheraputic Center, Miskolc, , Hungary
Zala Megyei Korhaz Pozva Diabetes Kulsokorhaz, Zalaegerszeg, , Hungary
University Hospital Company of Pisana, Pisa, PI, Italy
Ente Ospedaliero Ospedali Galliera, Genova, , Italy
IRCCS A.O.U. San Martino, Genova, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Ospedale San Raffaele, Milano, , Italy
S.C. Oncologia Medica Azienda Ospedaliera Valtellina e Valchiavenna Presidio Ospedaliero di Sondrio, Sondrio, , Italy
Azienda Ospedaliera Treviglio Caravaggio U.O. Oncologia Medica, Treviglio, , Italy
Centro de Investigacion Instituto de oncologia y Radiotherpia de la Clinica, San Isidro, Lima, Peru
Centro Medico monte Carmelo, Arequipa, , Peru
Clinica Anglo Americana Calle Alfredo Salazar, San Isidro, , Peru
Beskidzkie Oncology Center, Bielsko-Biala, , Poland
Wojewodzki Szpital Zespolony w Elblagu Oddzial Onkologiczny, Elblag, , Poland
Wielkopolskie Centrum Onkologii, Poznan, , Poland
Mrukmed Lekarz Beata Madej Mruk i Partner Spolka Partnerska Oddzial Nr 1 w Rzeszowie, Rzeszow, , Poland
Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu, Torun, , Poland
Wojskowy Instytut Medyczny, Warsaw, , Poland
Klinka Gastroenterologii Okologicznej Centrum Okologii Instytut, Warszawa, , Poland
Medisprof srl Oncologie P TA, Cluj-Napoca, Judet Cluj, Romania
Fundeni Clinical Institute, Bucuresti, , Romania
GRAL Medical SRL, Bucuresti, , Romania
Centrul de Oncologie Sfantul Nectarie SRL, Oncologie, Craiova, , Romania
Sc Oncolab Srl, Craiova, , Romania
SC Centrul de Oncologie Euroclinic SRL, Oncologie, Iaşi, , Romania
Spitalul Judetean De Urgenta Sf Ion Cel Nou Suceava Sectia Oncologie Medicala Bdul, Suceava, , Romania
Hospital Universitario de A Coruna C, A Coruna, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Del Mar Servicio de Oncologia, Barcelona, , Spain
Hospital Parc Tauli, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Institut Catala de la Salut, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Puerta de Hierro, Madrid, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Hospital Universitario Morales Meseguer, Murcia, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital Virgen de Valme, Sevilla, , Spain
Cukurova Universitesi, Adana, , Turkey
Ankara University Medical Faculty Ibni Sina Hospital, Ankara, , Turkey
Hacettepe Universitesi Tip Facultesi Cocuk Saligi ve Hastaklikleri Anabilim Dali, Ankara, , Turkey
Hacettepe University, Ankara, , Turkey
University of Uludag, Bursa, , Turkey
Trakya University, Edirne, , Turkey
Bezmialem University Hospital, Istanbul, , Turkey
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi, Istanbul, , Turkey
Istanbul Universitesi Onkoloji Enstitusu Medikal Onkoloji Bilim Dali, Istanbul, , Turkey
Marmara University, Kadikoy, , Turkey
Izmir Universitesi Hastanesi Yeni Girne Vulvari, Karsiyaka, , Turkey
Kocaeli Universty, Kocaeli, , Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi Elazi, Malatya, , Turkey
Van Yuzuncu Yil Universitesi Tip Kaultesi Ic Hastaliklari Anabilim Dali Tibbi Okoloji Bilim Dali, Van, , Turkey
New Queen Elizabeth Hospital, Birmingham, , United Kingdom
Peterborough City Hospital Peterborough and Stamford Hospitals NHS Foundation Trust, Cambridge, , United Kingdom
Royal Marsden Hospital Mulberry House, London, , United Kingdom
University College London, London, , United Kingdom
Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR