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

Primary Purpose

Gastric Adenocarcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Andecaliximab
Placebo
Leucovorin
5-fluorouracil
Oxaliplatin
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring Gastroesophageal junction (GEJ), Stomach cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scripps Green Hospital
  • University of Southern California
  • UCLA Jonsson Comprehensive Cancer Center
  • Innovative Clinical Research Institute
  • Cancer Center of Central Connecticut
  • Omega Research Consultants LLC
  • Edward Hospital & Health Services
  • Parkview Hospital
  • Indiana University Goshen Center for Cancer Care
  • Ochsner Clinic Foundation
  • New England Cancer Specialists
  • Karamanos Cancer Institute
  • HCA Healthcare
  • Carol G. Simon Cancer Center
  • Regional Cancer Care Associates LLC - Sparta
  • Weill Cornell Medical College - New York Presbyterian Hospital
  • University of Rochester
  • Duke Cancer Institute
  • Oncology Hematology Care, Inc.
  • The Ohio State Medical Center
  • Northwest Cancer Specialists
  • Charleston Hematology Oncology Associates
  • Prairie Lakes Health Care System INC
  • Tennessee Oncology
  • Center for Cancer Blood Disorders
  • The University of Texas MD Anderson Cancer Center
  • Texas Oncology-Seton Williamson
  • Scott and White Memorial Hospital
  • Utah Cancer Specialists
  • Virginia Commonwealth University
  • Virginia Mason Seattle Main Clinic
  • The Canberra Hospital
  • Chris O'Brien Lifehouse
  • The Crown Princess Mary Cancer Centre
  • Princess Alexandra Hospital
  • Ashford Cancer Centre
  • Royal Hobart Hospital
  • Epworth Healthcare
  • Western Health Sunshine Hospital
  • The Tweed Hospital
  • Sydney Adventist Hospital
  • Centre Hospitalizer De L'Ardenne
  • University Hospital Gent Department of Gastroenterology
  • Instituto Nacional Del Cancer
  • Instituto Clinico Oncologico del Sur
  • Hospital Clinico Vina Del Mar
  • Oncomedica S.A
  • Dundacion Oftalmologica de Santander Clinica Ardila Lulle La Foscal
  • Hospital Pablo Tobon Uribe
  • Centro Medico Imbanaco de Cali S.A
  • Fakultni Nemocnice Brno
  • Fakultni nemocnice Hradec Kralove
  • University Hospital - Czech
  • Thomayer Hospital
  • Oblastni Nemocnice Pribram
  • CHU Jean Minjoz
  • CHRU de Brest, Hopital Morvan, Institut de Cancerologie et d'Hematologie
  • Hôpitaux Civils de Colmar
  • Institut Paoli Calmettes
  • CHU de Nice-l Archet
  • CH Annecy-Gennevois
  • Kliniken Nordoberpfalz AG
  • Klinikum rechts der Isar Technical University of Ismaninger
  • DRK Klinken Berlin Abteilungsleiter Chiurgische Okologie
  • Universitätsklinikum Carl Gustav Carus
  • Kliniken Essen Mitte Studiensekretariat Onkologie Evang. Huyssens-Stiftung
  • Krankenhaus Nordwest gGmbH Institut für Klinisch Onkologische Med Klinik II
  • Cancer Center Heilbronn-Franken, SLK-Kliniken
  • Staedtisches Klinikum Muenchen Bogenhausen
  • Zentrum fur Innere Medizin Stauferklinikum Schwab
  • Universitatsklinikum Ulm
  • Egyesített Szent István és Szent László Kórház -Rendelőintézet
  • Debreceni Egyetem Klinikai Központ
  • Human Klinikai Vizsgalatok Regisztracios Kozpont - HKVRK
  • Pandy Kalman Hospital
  • Borsod County Hospital Clinical Oncological and Radiotheraputic Center
  • Zala Megyei Korhaz Pozva Diabetes Kulsokorhaz
  • University Hospital Company of Pisana
  • Ente Ospedaliero Ospedali Galliera
  • IRCCS A.O.U. San Martino
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Ospedale San Raffaele
  • S.C. Oncologia Medica Azienda Ospedaliera Valtellina e Valchiavenna Presidio Ospedaliero di Sondrio
  • Azienda Ospedaliera Treviglio Caravaggio U.O. Oncologia Medica
  • Centro de Investigacion Instituto de oncologia y Radiotherpia de la Clinica
  • Centro Medico monte Carmelo
  • Clinica Anglo Americana Calle Alfredo Salazar
  • Beskidzkie Oncology Center
  • Wojewodzki Szpital Zespolony w Elblagu Oddzial Onkologiczny
  • Wielkopolskie Centrum Onkologii
  • Mrukmed Lekarz Beata Madej Mruk i Partner Spolka Partnerska Oddzial Nr 1 w Rzeszowie
  • Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
  • Wojskowy Instytut Medyczny
  • Klinka Gastroenterologii Okologicznej Centrum Okologii Instytut
  • Medisprof srl Oncologie P TA
  • Fundeni Clinical Institute
  • GRAL Medical SRL
  • Centrul de Oncologie Sfantul Nectarie SRL, Oncologie
  • Sc Oncolab Srl
  • SC Centrul de Oncologie Euroclinic SRL, Oncologie
  • Spitalul Judetean De Urgenta Sf Ion Cel Nou Suceava Sectia Oncologie Medicala Bdul
  • Hospital Universitario de A Coruna C
  • Hospital Clinic de Barcelona
  • Hospital Del Mar Servicio de Oncologia
  • Hospital Parc Tauli
  • Hospital Universitari Vall d'Hebron
  • Institut Catala de la Salut
  • Hospital General Universitario Gregorio Maranon
  • Hospital Ramon y Cajal
  • Hospital Universitario La Paz
  • Hospital Universitario Puerta de Hierro
  • Hospital Regional Universitario de Malaga
  • Hospital Universitario Morales Meseguer
  • Complejo Hospitalario de Navarra
  • Hospital Virgen de Valme
  • Cukurova Universitesi
  • Ankara University Medical Faculty Ibni Sina Hospital
  • Hacettepe Universitesi Tip Facultesi Cocuk Saligi ve Hastaklikleri Anabilim Dali
  • Hacettepe University
  • University of Uludag
  • Trakya University
  • Bezmialem University Hospital
  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
  • Istanbul Universitesi Onkoloji Enstitusu Medikal Onkoloji Bilim Dali
  • Marmara University
  • Izmir Universitesi Hastanesi Yeni Girne Vulvari
  • Kocaeli Universty
  • Inonu Universitesi Turgut Ozal Tip Merkezi Elazi
  • Van Yuzuncu Yil Universitesi Tip Kaultesi Ic Hastaliklari Anabilim Dali Tibbi Okoloji Bilim Dali
  • New Queen Elizabeth Hospital
  • Peterborough City Hospital Peterborough and Stamford Hospitals NHS Foundation Trust
  • Royal Marsden Hospital Mulberry House
  • University College London
  • Christie Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Andecaliximab

Placebo

Arm Description

Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles

Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 8, 2015
Last Updated
May 11, 2020
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02545504
Brief Title
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Acronym
GAMMA-1
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 Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 13, 2015 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
Keywords
Gastroesophageal junction (GEJ), Stomach cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Andecaliximab
Arm Type
Experimental
Arm Description
Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
Intervention Type
Drug
Intervention Name(s)
Andecaliximab
Other Intervention Name(s)
GS-5745
Intervention Description
800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered intravenously on Days 1 and 15 of each treatment cycle
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
LV
Intervention Description
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
OXA
Intervention Description
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time interval from the date of randomization to death from any cause.
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
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
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
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Up to 135.4 weeks at the time of final analysis
Title
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Description
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.
Time Frame
First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days
Title
Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities
Description
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.
Time Frame
First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33577358
Citation
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.
Results Reference
background

Learn more about this trial

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

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