Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
NCT ID: NCT02545504
Last Updated: 2020-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
432 participants
INTERVENTIONAL
2015-10-13
2019-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Andecaliximab
Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
Andecaliximab
800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Leucovorin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
5-fluorouracil
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Oxaliplatin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Placebo
Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
Placebo
Administered intravenously on Days 1 and 15 of each treatment cycle
Leucovorin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
5-fluorouracil
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Oxaliplatin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Interventions
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Andecaliximab
800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Placebo
Administered intravenously on Days 1 and 15 of each treatment cycle
Leucovorin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
5-fluorouracil
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Oxaliplatin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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 individuals requiring chronic daily treatment with oral corticosteroids
* Grade ≥ 2 peripheral neuropathy
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
Ghent, , Belgium
Instituto Nacional Del Cancer
Santiago, , Chile
Instituto Clinico Oncologico del Sur
Temuco, , Chile
Hospital Clinico Vina Del Mar
Viña del Mar, , Chile
Oncomedica S.A
Montería, Departamento de Córdoba, Colombia
Dundacion Oftalmologica de Santander Clinica Ardila Lulle La Foscal
Floridablanca, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Centro Medico Imbanaco de Cali S.A
Valle, , Colombia
Fakultni Nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
University Hospital - Czech
Olomouc, , Czechia
Thomayer Hospital
Prague, , Czechia
Oblastni Nemocnice Pribram
Příbram, , Czechia
CHU Jean Minjoz
Besançon, , France
CHRU de Brest, Hopital Morvan, Institut de Cancerologie et d'Hematologie
Brest, , France
Hôpitaux Civils de Colmar
Colmar, , France
Institut Paoli Calmettes
Marseille, , France
CHU de Nice-l Archet
Nice, , France
CH Annecy-Gennevois
Pringy, , France
Klinikum rechts der Isar Technical University of Ismaninger
Munich, Bavaria, Germany
Kliniken Nordoberpfalz AG
Weiden, Bavaria, 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
Zentrum fur Innere Medizin Stauferklinikum Schwab
Mutlangen, , Germany
Staedtisches Klinikum Muenchen Bogenhausen
München, , 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
Győr, , 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
Milan, , Italy
Ospedale San Raffaele
Milan, , 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 region, 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
Rzeszów, , Poland
Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
Torun, , Poland
Klinka Gastroenterologii Okologicznej Centrum Okologii Instytut
Warsaw, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Medisprof srl Oncologie P TA
Cluj-Napoca, Judet Cluj, Romania
Fundeni Clinical Institute
Bucharest, , Romania
GRAL Medical SRL
Bucharest, , Romania
Centrul de Oncologie Sfantul Nectarie SRL, Oncologie
Craiova, , Romania
Sc Oncolab Srl
Craiova, , Romania
SC Centrul de Oncologie Euroclinic SRL, Oncologie
Iași, , Romania
Spitalul Judetean De Urgenta Sf Ion Cel Nou Suceava Sectia Oncologie Medicala Bdul
Suceava, , Romania
Hospital Universitario de A Coruna C
A Coruña, , 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
Málaga, , Spain
Hospital Universitario Morales Meseguer
Murcia, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Hospital Virgen de Valme
Seville, , Spain
Cukurova Universitesi
Adana, , Turkey (Türkiye)
Ankara University Medical Faculty Ibni Sina Hospital
Ankara, , Turkey (Türkiye)
Hacettepe Universitesi Tip Facultesi Cocuk Saligi ve Hastaklikleri Anabilim Dali
Ankara, , Turkey (Türkiye)
Hacettepe University
Ankara, , Turkey (Türkiye)
University of Uludag
Bursa, , Turkey (Türkiye)
Trakya University
Edirne, , Turkey (Türkiye)
Bezmialem University Hospital
Istanbul, , Turkey (Türkiye)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi Onkoloji Enstitusu Medikal Onkoloji Bilim Dali
Istanbul, , Turkey (Türkiye)
Marmara University
Kadıköy, , Turkey (Türkiye)
Izmir Universitesi Hastanesi Yeni Girne Vulvari
Karşıyaka, , Turkey (Türkiye)
Kocaeli Universty
Kocaeli, , Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Tip Merkezi Elazi
Malatya, , Turkey (Türkiye)
Van Yuzuncu Yil Universitesi Tip Kaultesi Ic Hastaliklari Anabilim Dali Tibbi Okoloji Bilim Dali
Van, , Turkey (Türkiye)
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
Countries
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References
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Shah MA, Bodoky G, Starodub A, Cunningham D, Yip D, Wainberg ZA, Bendell J, Thai D, He J, Bhargava P, Ajani JA. Phase III Study to Evaluate Efficacy and Safety of Andecaliximab With mFOLFOX6 as First-Line Treatment in Patients With Advanced Gastric or GEJ Adenocarcinoma (GAMMA-1). J Clin Oncol. 2021 Mar 20;39(9):990-1000. doi: 10.1200/JCO.20.02755. Epub 2021 Feb 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-001526-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-296-1080
Identifier Type: -
Identifier Source: org_study_id
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