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Gastric AdenocarcinomaPhase 3GAMMA-1NCT02545504

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

A Phase 3 study testing Andecaliximab, Leucovorin and 5-fluorouracil in people with Gastric Adenocarcinoma, run by Gilead Sciences at 134 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Adenocarcinoma
What is being tested?
Andecaliximab, Leucovorin and 5-fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
432 participants
Where
134 sitesin 16 countries
Study dates
13 Oct 2015to 15 May 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

134 sites in 16 countries.

134 sites in 16 countries

United States31 sites

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29403

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • The Ohio State Medical Center

    Columbus, Ohio, 43210

  • Omega Research Consultants LLC

    DeBary, Florida, 32713

  • Karamanos Cancer Institute

    Detroit, Michigan, 48175

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • Parkview Hospital

    Fort Wayne, Indiana, 46805

  • Center for Cancer Blood Disorders

    Fort Worth, Texas

  • Indiana University Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas

  • HCA Healthcare

    Kansas City, Missouri, 64030

  • Scripps Green Hospital

    La Jolla, California, 92037

  • University of Southern California

    Los Angeles, California, 90007

  • UCLA Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90024

  • Carol G. Simon Cancer Center

    Morristown, New Jersey, 07901

  • Edward Hospital & Health Services

    Naperville, Illinois, 60540

  • Tennessee Oncology

    Nashville, Tennessee

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70816

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York, 10065

  • Cancer Center of Central Connecticut

    Plainville, Connecticut, 06062

  • Northwest Cancer Specialists

    Portland, Oregon, 97213

  • Virginia Commonwealth University

    Richmond, Virginia

  • University of Rochester

    Rochester, New York, 14627

  • Texas Oncology-Seton Williamson

    Round Rock, Texas

  • Utah Cancer Specialists

    Salt Lake City, Utah

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Virginia Mason Seattle Main Clinic

    Seattle, Washington

  • Regional Cancer Care Associates LLC - Sparta

    Sparta, New Jersey, 07871

  • Scott and White Memorial Hospital

    Temple, Texas

  • Prairie Lakes Health Care System INC

    Watertown, South Dakota

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

Spain14 sites

  • Hospital Universitario de A Coruna C

    A Coruña

  • Hospital Clinic de Barcelona

    Barcelona

  • Hospital Del Mar Servicio de Oncologia

    Barcelona

  • Hospital Parc Tauli

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Institut Catala de la Salut

    Barcelona

  • Hospital General Universitario Gregorio Maranon

    Madrid

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Puerta de Hierro

    Madrid

  • Hospital Regional Universitario de Malaga

    Málaga

  • Hospital Universitario Morales Meseguer

    Murcia

  • Complejo Hospitalario de Navarra

    Pamplona

  • Hospital Virgen de Valme

    Seville

Other trials in Spain

Turkey (Türkiye)14 sites

  • Cukurova Universitesi

    Adana

  • Ankara University Medical Faculty Ibni Sina Hospital

    Ankara

  • Hacettepe Universitesi Tip Facultesi Cocuk Saligi ve Hastaklikleri Anabilim Dali

    Ankara

  • Hacettepe University

    Ankara

  • University of Uludag

    Bursa

  • Izmir Universitesi Hastanesi Yeni Girne Vulvari

    Cordaleo

  • Trakya University

    Edirne

  • Bezmialem University Hospital

    Istanbul

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Istanbul

  • Istanbul Universitesi Onkoloji Enstitusu Medikal Onkoloji Bilim Dali

    Istanbul

  • Marmara University

    Kadıköy

  • Kocaeli Universty

    Kocaeli

  • Inonu Universitesi Turgut Ozal Tip Merkezi Elazi

    Malatya

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

    Van

Other trials in Turkey (Türkiye)

Australia10 sites

  • Princess Alexandra Hospital

    Brisbane, Queensland

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales

  • The Canberra Hospital

    Garran, Australian Capital Territory

  • Royal Hobart Hospital

    Hobart, Tasmania

  • Ashford Cancer Centre

    Kurralta Park, South Australia

  • Epworth Healthcare

    Richmond, Victoria

  • Western Health Sunshine Hospital

    St Albans, Victoria

  • The Tweed Hospital

    Tweed Heads, 2485

  • Sydney Adventist Hospital

    Wahroonga

  • The Crown Princess Mary Cancer Centre

    Westmead, New South Wales

Other trials in Australia

Germany10 sites

  • DRK Klinken Berlin Abteilungsleiter Chiurgische Okologie

    Berlin

  • Universitätsklinikum Carl Gustav Carus

    Dresden

  • Kliniken Essen Mitte Studiensekretariat Onkologie Evang. Huyssens-Stiftung

    Essen

  • Krankenhaus Nordwest gGmbH Institut für Klinisch Onkologische Med Klinik II

    Frankfurt

  • Cancer Center Heilbronn-Franken, SLK-Kliniken

    Heilbronn

  • Staedtisches Klinikum Muenchen Bogenhausen

    München

  • Klinikum rechts der Isar Technical University of Ismaninger

    Munich, Bavaria

  • Zentrum fur Innere Medizin Stauferklinikum Schwab

    Mutlangen

  • Universitatsklinikum Ulm

    Ulm

  • Kliniken Nordoberpfalz AG

    Weiden, Bavaria

Other trials in Germany

Italy7 sites

  • Ente Ospedaliero Ospedali Galliera

    Genova

  • IRCCS A.O.U. San Martino

    Genova

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

  • Ospedale San Raffaele

    Milan

  • University Hospital Company of Pisana

    Pisa, PI

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

    Sondrio

  • Azienda Ospedaliera Treviglio Caravaggio U.O. Oncologia Medica

    Treviglio

Other trials in Italy

Poland7 sites

  • Beskidzkie Oncology Center

    Bielsko-Biala

  • Wojewodzki Szpital Zespolony w Elblagu Oddzial Onkologiczny

    Elblag

  • Wielkopolskie Centrum Onkologii

    Poznan

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

    Rzeszów

  • Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu

    Torun

  • Klinka Gastroenterologii Okologicznej Centrum Okologii Instytut

    Warsaw

  • Wojskowy Instytut Medyczny

    Warsaw

Other trials in Poland

Romania7 sites

  • Fundeni Clinical Institute

    Bucharest

  • GRAL Medical SRL

    Bucharest

  • Medisprof srl Oncologie P TA

    Cluj-Napoca, Judet Cluj

  • Centrul de Oncologie Sfantul Nectarie SRL, Oncologie

    Craiova

  • Sc Oncolab Srl

    Craiova

  • SC Centrul de Oncologie Euroclinic SRL, Oncologie

    Iași

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

    Suceava

Other trials in Romania

France6 sites

  • CHU Jean Minjoz

    Besançon

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

    Brest

  • Hôpitaux Civils de Colmar

    Colmar

  • Institut Paoli Calmettes

    Marseille

  • CHU de Nice-l Archet

    Nice

  • CH Annecy-Gennevois

    Pringy

Other trials in France

Hungary6 sites

  • Egyesített Szent István és Szent László Kórház -Rendelőintézet

    Budapest

  • Debreceni Egyetem Klinikai Központ

    Debrecen

  • Human Klinikai Vizsgalatok Regisztracios Kozpont - HKVRK

    Győr

  • Pandy Kalman Hospital

    Gyula

  • Borsod County Hospital Clinical Oncological and Radiotheraputic Center

    Miskolc

  • Zala Megyei Korhaz Pozva Diabetes Kulsokorhaz

    Zalaegerszeg

Other trials in Hungary

Czechia5 sites

  • Fakultni Nemocnice Brno

    Brno

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové

  • University Hospital - Czech

    Olomouc

  • Thomayer Hospital

    Prague

  • Oblastni Nemocnice Pribram

    Příbram

Other trials in Czechia

United Kingdom5 sites

  • New Queen Elizabeth Hospital

    Birmingham

  • Peterborough City Hospital Peterborough and Stamford Hospitals NHS Foundation Trust

    Cambridge

  • Royal Marsden Hospital Mulberry House

    London

  • University College London

    London

  • Christie Hospital NHS Foundation Trust

    Manchester

Other trials in United Kingdom

Colombia4 sites

  • Dundacion Oftalmologica de Santander Clinica Ardila Lulle La Foscal

    Floridablanca

  • Hospital Pablo Tobon Uribe

    Medellín

  • Oncomedica S.A

    Montería, Departamento de Córdoba

  • Centro Medico Imbanaco de Cali S.A

    Valle

Other trials in Colombia

Chile3 sites

  • Instituto Nacional Del Cancer

    Santiago

  • Instituto Clinico Oncologico del Sur

    Temuco

  • Hospital Clinico Vina Del Mar

    Viña del Mar

Other trials in Chile

Peru3 sites

  • Centro Medico monte Carmelo

    Arequipa

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

    San Isidro, Lima region

  • Clinica Anglo Americana Calle Alfredo Salazar

    San Isidro

Other trials in Peru

Belgium2 sites

  • University Hospital Gent Department of Gastroenterology

    Ghent

  • Centre Hospitalizer De L'Ardenne

    Libramont, Chevigny

Other trials in Belgium

About this study

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

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.

Being tested
Andecaliximab, Placebo, Leucovorin, 5-fluorouracil, Oxaliplatin
Keywords
Gastroesophageal junction (GEJ), Stomach cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AndecaliximabDrug

    Also called GS-5745

    800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle

  • PlaceboDrug

    Administered intravenously on Days 1 and 15 of each treatment cycle

  • LeucovorinDrug

    Also called LV

    Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle

  • 5-fluorouracilDrug

    Also called 5-FU

    Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle

  • OxaliplatinDrug

    Also called OXA

    Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle

Study groups in NCT02545504
Study groupRoleWhat they receive
AndecaliximabExperimentalAndecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
Receives: Drug: Andecaliximab; Drug: Leucovorin; Drug: 5-fluorouracil; Drug: Oxaliplatin
PlaceboPlacebo comparatorPlacebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
Receives: Drug: Placebo; Drug: Leucovorin; Drug: 5-fluorouracil; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS was defined as the time interval from the date of randomization to death from any cause.

    Measured: 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 outcomes (4)

  1. Progression-free Survival (PFS)

    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.

    Measured: 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

  2. Objective Response Rate (ORR)

    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.

    Measured: Up to 135.4 weeks at the time of final analysis

  3. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    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.

    Measured: First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days

  4. Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities

    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.

    Measured: First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2015 (estimated)
  2. Study start13 Oct 2015
  3. Primary completion15 May 2019
  4. Study completion15 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
432 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02545504
Sponsor's protocol ID
GS-US-296-1080
Other IDs
2015-001526-42, 2015
Acronym
GAMMA-1
Status last verified
May 2020
First submitted
8 Sep 2015
Last updated
26 May 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33577358

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Andecaliximab, Leucovorin and 5-fluorouracil in people with Gastric Adenocarcinoma, run by Gilead Sciences at 134 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, Spain, Turkey (Türkiye), Australia, Germany and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02545504, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.

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