Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (GAMMA-1)

May 11, 2020 updated by: Gilead Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

432

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Tweed Heads, Australia, 2485
        • The Tweed Hospital
      • Wahroonga, Australia
        • Sydney Adventist Hospital
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia
        • The Canberra Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia
        • Chris O'Brien Lifehouse
      • Westmead, New South Wales, Australia
        • The Crown Princess Mary Cancer Centre
    • Queensland
      • Brisbane, Queensland, Australia
        • Princess Alexandra Hospital
    • South Australia
      • Kurralta Park, South Australia, Australia
        • Ashford Cancer Centre
    • Tasmania
      • Hobart, Tasmania, Australia
        • Royal Hobart Hospital
    • Victoria
      • Richmond, Victoria, Australia
        • Epworth Healthcare
      • St Albans, Victoria, Australia
        • Western Health Sunshine Hospital
  • Belgium
      • Gent, Belgium
        • University Hospital Gent Department of Gastroenterology
    • Chevigny
      • Libramont, Chevigny, Belgium
        • Centre Hospitalizer De L'Ardenne
  • Chile
      • Santiago, Chile
        • Instituto Nacional del Cancer
      • Temuco, Chile
        • Instituto Clinico Oncologico del Sur
      • Vina del Mar, Chile
        • Hospital Clinico Vina del Mar
  • Colombia
      • Floridablanca, Colombia
        • Dundacion Oftalmologica de Santander Clinica Ardila Lulle La Foscal
      • Medellin, Colombia
        • Hospital Pablo Tobon Uribe
      • Valle, Colombia
        • Centro Medico Imbanaco de Cali S.A
    • Cordoba
      • Monteria, Cordoba, Colombia
        • Oncomedica S.A
  • Czechia
      • Brno, Czechia
        • Fakultni nemocnice Brno
      • Hradec Kralove, Czechia
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia
        • University Hospital - Czech
      • Prague 4, Czechia
        • Thomayer Hospital
      • Pribram, Czechia
        • Oblastni nemocnice Pribram
  • France
      • Besancon, France
        • Chu Jean Minjoz
      • Brest Cedex, France
        • CHRU de Brest, Hopital Morvan, Institut de Cancerologie et d'Hematologie
      • Colmar, France
        • Hôpitaux Civils de Colmar
      • Marseille Cedex 9, France
        • Institut Paoli Calmettes
      • Nice Cedex 3, France
        • CHU de Nice-l Archet
      • Pringy Cedex, France
        • CH Annecy-Gennevois
  • Germany
      • Berlin, Germany
        • DRK Klinken Berlin Abteilungsleiter Chiurgische Okologie
      • Dresden, Germany
        • Universitatsklinikum Carl Gustav Carus
      • Essen, Germany
        • Kliniken Essen Mitte Studiensekretariat Onkologie Evang. Huyssens-Stiftung
      • Frankfurt, Germany
        • Krankenhaus Nordwest gGmbH Institut für Klinisch Onkologische Med Klinik II
      • Heilbronn, Germany
        • Cancer Center Heilbronn-Franken, SLK-Kliniken
      • Muenchen, Germany
        • Staedtisches Klinikum Muenchen Bogenhausen
      • Mutlangen, Germany
        • Zentrum fur Innere Medizin Stauferklinikum Schwab
      • Ulm, Germany
        • Universitatsklinikum Ulm
    • Bavaria
      • Weiden, Bavaria, Germany
        • Kliniken Nordoberpfalz AG
    • Bayern
      • Munich, Bayern, Germany
        • Klinikum rechts der Isar Technical University of Ismaninger
  • Hungary
      • Budapest, Hungary
        • Egyesített Szent István és Szent László Kórház -Rendelőintézet
      • Debrecen, Hungary
        • Debreceni Egyetem Klinikai Kozpont
      • Gyor, Hungary
        • Human Klinikai Vizsgalatok Regisztracios Kozpont - HKVRK
      • Gyula, Hungary
        • Pandy Kalman Hospital
      • Miskolc, Hungary
        • Borsod County Hospital Clinical Oncological and Radiotheraputic Center
      • Zalaegerszeg, Hungary
        • Zala Megyei Korhaz Pozva Diabetes Kulsokorhaz
  • Italy
      • Genova, Italy
        • Ente Ospedaliero Ospedali Galliera
      • Genova, Italy
        • IRCCS A.O.U. San Martino
      • Milano, Italy
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milano, Italy
        • Ospedale San Raffaele
      • Sondrio, Italy
        • S.C. Oncologia Medica Azienda Ospedaliera Valtellina e Valchiavenna Presidio Ospedaliero di Sondrio
      • Treviglio, Italy
        • Azienda Ospedaliera Treviglio Caravaggio U.O. Oncologia Medica
    • PI
      • Pisa, PI, Italy
        • University Hospital Company of Pisana
  • Peru
      • Arequipa, Peru
        • Centro Medico Monte Carmelo
      • San Isidro, Peru
        • Clinica Anglo Americana Calle Alfredo Salazar
    • Lima
      • San Isidro, Lima, Peru
        • Centro de Investigacion Instituto de oncologia y Radiotherpia de la Clinica
  • Poland
      • Bielsko-Biala, Poland
        • Beskidzkie Oncology Center
      • Elblag, Poland
        • Wojewodzki Szpital Zespolony w Elblagu Oddzial Onkologiczny
      • Poznan, Poland
        • Wielkopolskie Centrum Onkologii
      • Rzeszow, Poland
        • Mrukmed Lekarz Beata Madej Mruk i Partner Spolka Partnerska Oddzial Nr 1 w Rzeszowie
      • Torun, Poland
        • Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
      • Warsaw, Poland
        • Wojskowy Instytut Medyczny
      • Warszawa, Poland
        • Klinka Gastroenterologii Okologicznej Centrum Okologii Instytut
  • Romania
      • Bucuresti, Romania
        • Fundeni Clinical Institute
      • Bucuresti, Romania
        • Gral Medical SRL
      • Craiova, Romania
        • Centrul de Oncologie Sfantul Nectarie SRL, Oncologie
      • Craiova, Romania
        • Sc Oncolab Srl
      • Iaşi, Romania
        • SC Centrul de Oncologie Euroclinic SRL, Oncologie
      • Suceava, Romania
        • Spitalul Judetean De Urgenta Sf Ion Cel Nou Suceava Sectia Oncologie Medicala Bdul
    • Judet Cluj
      • Cluj-Napoca, Judet Cluj, Romania
        • Medisprof srl Oncologie P TA
  • Spain
      • A Coruna, Spain
        • Hospital Universitario de A Coruna C
      • Barcelona, Spain
        • Hospital Clinic de Barcelona
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain
        • Hospital Del Mar Servicio de Oncologia
      • Barcelona, Spain
        • Hospital Parc Tauli
      • Barcelona, Spain
        • Institut Català de la Salut
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario Puerta de Hierro
      • Malaga, Spain
        • Hospital Regional Universitario de Malaga
      • Murcia, Spain
        • Hospital Universitario Morales Meseguer
      • Pamplona, Spain
        • Complejo Hospitalario de Navarra
      • Sevilla, Spain
        • Hospital Virgen de Valme
  • Turkey
      • Adana, Turkey
        • Çukurova Üniversitesi
      • Ankara, Turkey
        • Hacettepe University
      • Ankara, Turkey
        • Ankara University Medical Faculty Ibni Sina Hospital
      • Ankara, Turkey
        • Hacettepe Universitesi Tip Facultesi Cocuk Saligi ve Hastaklikleri Anabilim Dali
      • Bursa, Turkey
        • University of Uludag
      • Edirne, Turkey
        • Trakya University
      • Istanbul, Turkey
        • Bezmialem University Hospital
      • Istanbul, Turkey
        • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
      • Istanbul, Turkey
        • Istanbul Universitesi Onkoloji Enstitusu Medikal Onkoloji Bilim Dali
      • Kadikoy, Turkey
        • Marmara University
      • Karsiyaka, Turkey
        • Izmir Universitesi Hastanesi Yeni Girne Vulvari
      • Kocaeli, Turkey
        • Kocaeli Universty
      • Malatya, Turkey
        • Inonu Universitesi Turgut Ozal Tip Merkezi Elazi
      • Van, Turkey
        • Van Yuzuncu Yil Universitesi Tip Kaultesi Ic Hastaliklari Anabilim Dali Tibbi Okoloji Bilim Dali
  • United Kingdom
      • Birmingham, United Kingdom
        • New Queen Elizabeth Hospital
      • Cambridge, United Kingdom
        • Peterborough City Hospital Peterborough and Stamford Hospitals NHS Foundation Trust
      • London, United Kingdom
        • University College London
      • London, United Kingdom
        • Royal Marsden Hospital Mulberry House
      • Manchester, United Kingdom
        • Christie Hospital NHS Foundation Trust
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital
      • Los Angeles, California, United States, 90007
        • University of Southern California
      • Los Angeles, California, United States, 90024
        • UCLA Jonsson Comprehensive Cancer Center
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute
    • Connecticut
      • Plainville, Connecticut, United States, 06062
        • Cancer Center of Central Connecticut
    • Florida
      • DeBary, Florida, United States, 32713
        • Omega Research Consultants LLC
    • Illinois
      • Naperville, Illinois, United States, 60540
        • Edward Hospital & Health Services
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Parkview Hospital
      • Goshen, Indiana, United States, 46526
        • Indiana University Goshen Center for Cancer Care
    • Louisiana
      • New Orleans, Louisiana, United States, 70816
        • Ochsner Clinic Foundation
    • Maine
      • Scarborough, Maine, United States, 04074
        • New England Cancer Specialists
    • Michigan
      • Detroit, Michigan, United States, 48175
        • Karamanos Cancer Institute
    • Missouri
      • Kansas City, Missouri, United States, 64030
        • HCA Healthcare
    • New Jersey
      • Morristown, New Jersey, United States, 07901
        • Carol G. Simon Cancer Center
      • Sparta, New Jersey, United States, 07871
        • Regional Cancer Care Associates LLC - Sparta
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College - New York Presbyterian Hospital
      • Rochester, New York, United States, 14627
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care, Inc.
      • Columbus, Ohio, United States, 43210
        • The Ohio State Medical Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Northwest Cancer Specialists
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology Associates
    • South Dakota
      • Watertown, South Dakota, United States
        • Prairie Lakes Health Care System INC
    • Tennessee
      • Nashville, Tennessee, United States
        • Tennessee Oncology
    • Texas
      • Fort Worth, Texas, United States
        • Center for Cancer Blood Disorders
      • Houston, Texas, United States
        • The University of Texas MD Anderson Cancer Center
      • Round Rock, Texas, United States
        • Texas Oncology-Seton Williamson
      • Temple, Texas, United States
        • Scott and White Memorial Hospital
    • Utah
      • Salt Lake City, Utah, United States
        • Utah Cancer Specialists
    • Virginia
      • Richmond, Virginia, United States
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States
        • Virginia Mason Seattle Main Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Adults with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction that is inoperable, locally advanced or metastatic and not amenable to curative 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

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 individuals requiring chronic daily treatment with oral corticosteroids
  • Grade ≥ 2 peripheral neuropathy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Andecaliximab
Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
Drug: Andecaliximab
800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Other Names:
  • GS-5745
Drug: Leucovorin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Names:
  • LV
Drug: 5-fluorouracil
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Names:
  • 5-FU
Drug: Oxaliplatin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Names:
  • OXA
Placebo Comparator: Placebo
Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
Drug: Leucovorin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Names:
  • LV
Drug: 5-fluorouracil
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Names:
  • 5-FU
Drug: Oxaliplatin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Names:
  • OXA
Drug: Placebo
Administered intravenously on Days 1 and 15 of each treatment cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Andecaliximab + mFOLFOX6 median follow-up at the time of final analysis: 19.43 months; Placebo + mFOLFOX6 median follow-up at the time of the final analysis: 19.45 months
OS was defined as the time interval from the date of randomization to death from any cause.
Andecaliximab + mFOLFOX6 median follow-up at the time of final analysis: 19.43 months; Placebo + mFOLFOX6 median follow-up at the time of the final analysis: 19.45 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: Andecaliximab + mFOLFOX6 median follow-up at the time of the final analysis: 18.64 months; Placebo + mFOLFOX6 median follow-up at the time of the final analysis: 18.74 months
PFS was defined as the interval of time from the date of randomization to the earlier of the first documentation of definitive disease progression or death from any cause.
Andecaliximab + mFOLFOX6 median follow-up at the time of the final analysis: 18.64 months; Placebo + mFOLFOX6 median follow-up at the time of the final analysis: 18.74 months
Objective Response Rate (ORR)
Time Frame: Up to 135.4 weeks at the time of final analysis
ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Up to 135.4 weeks at the time of final analysis
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. TEAEs are events in a given study period that meet any of the following criteria: Any AE with onset date of on or after andecalizimab/placebo start date and no later than 30 days after permanent discontinuation of all study treatment (andecaliximab/placebo and chemotherapy) or Any AEs with onset date of on or after the andecaliximab/placebo start date and no later than 55 days after permanent discontinuation of andecaliximab/placebo or AEs leading to discontinuation of andecaliximab/placebo.
First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days
Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities
Time Frame: First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days
Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to 30 days after the last dose of all study treatment, or 55 days after the last dose of andecaliximab/placebo for participants who permanently discontinued all study treatments. If the relevant baseline laboratory value is missing, then any abnormality of at least Grade 1 was considered treatment-emergent.
First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Shah et al A phase III, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of andecaliximab combined with mFOLFOX6 as first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma (GAMMA-1)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2015

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

May 15, 2019

Study Registration Dates

First Submitted

September 8, 2015

First Submitted That Met QC Criteria

September 8, 2015

First Posted (Estimate)

September 10, 2015

Study Record Updates

Last Update Posted (Actual)

May 26, 2020

Last Update Submitted That Met QC Criteria

May 11, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-296-1080
  • 2015-001526-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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