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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02545504
Other study ID # GS-US-296-1080
Secondary ID 2015-001526-42
Status Completed
Phase Phase 3
First received
Last updated
Start date October 13, 2015
Est. completion date May 15, 2019

Study information

Verified date May 2020
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 432
Est. completion date May 15, 2019
Est. primary completion date May 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Australia Princess Alexandra Hospital Brisbane Queensland
Australia Chris O'Brien Lifehouse Camperdown New South Wales
Australia The Canberra Hospital Garran Australian Capital Territory
Australia Royal Hobart Hospital Hobart Tasmania
Australia Ashford Cancer Centre Kurralta Park South Australia
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 The Crown Princess Mary Cancer Centre Westmead New South Wales
Belgium University Hospital Gent Department of Gastroenterology Gent
Belgium Centre Hospitalizer De L'Ardenne Libramont Chevigny
Chile Instituto Nacional Del Cancer Santiago
Chile Instituto Clinico Oncologico del Sur Temuco
Chile Hospital Clinico Vina Del Mar Vina del Mar
Colombia Dundacion Oftalmologica de Santander Clinica Ardila Lulle La Foscal Floridablanca
Colombia Hospital Pablo Tobon Uribe Medellin
Colombia Oncomedica S.A Monteria Cordoba
Colombia Centro Medico Imbanaco de Cali S.A Valle
Czechia 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
France 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
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 Klinikum rechts der Isar Technical University of Ismaninger Munich Bayern
Germany Zentrum fur Innere Medizin Stauferklinikum Schwab Mutlangen
Germany Universitatsklinikum Ulm Ulm
Germany Kliniken Nordoberpfalz AG Weiden Bavaria
Hungary Egyesített Szent István és Szent László Kórház -Rendelointézet 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
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 University Hospital Company of Pisana Pisa PI
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
Peru Centro Medico monte Carmelo Arequipa
Peru Centro de Investigacion Instituto de oncologia y Radiotherpia de la Clinica San Isidro Lima
Peru Clinica Anglo Americana Calle Alfredo Salazar San Isidro
Poland 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
Romania Fundeni Clinical Institute Bucuresti
Romania GRAL Medical SRL Bucuresti
Romania Medisprof srl Oncologie P TA Cluj-Napoca Judet Cluj
Romania Centrul de Oncologie Sfantul Nectarie SRL, Oncologie Craiova
Romania Sc Oncolab Srl Craiova
Romania SC Centrul de Oncologie Euroclinic SRL, Oncologie Iasi
Romania Spitalul Judetean De Urgenta Sf Ion Cel Nou Suceava Sectia Oncologie Medicala Bdul Suceava
Spain 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
Turkey 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
United Kingdom 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 States Charleston Hematology Oncology Associates Charleston South Carolina
United States Oncology Hematology Care, Inc. Cincinnati Ohio
United States The Ohio State Medical Center Columbus Ohio
United States Omega Research Consultants LLC DeBary Florida
United States Karamanos Cancer Institute Detroit Michigan
United States Duke Cancer Institute Durham North Carolina
United States Parkview Hospital Fort Wayne Indiana
United States Center for Cancer Blood Disorders Fort Worth Texas
United States Indiana University Goshen Center for Cancer Care Goshen Indiana
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States HCA Healthcare Kansas City Missouri
United States Scripps Green Hospital La Jolla California
United States UCLA Jonsson Comprehensive Cancer Center Los Angeles California
United States University of Southern California Los Angeles California
United States Carol G. Simon Cancer Center Morristown New Jersey
United States Edward Hospital & Health Services Naperville Illinois
United States Tennessee Oncology Nashville Tennessee
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Weill Cornell Medical College - New York Presbyterian Hospital New York New York
United States Cancer Center of Central Connecticut Plainville Connecticut
United States Northwest Cancer Specialists Portland Oregon
United States Virginia Commonwealth University Richmond Virginia
United States University of Rochester Rochester New York
United States Texas Oncology-Seton Williamson Round Rock Texas
United States Utah Cancer Specialists Salt Lake City Utah
United States New England Cancer Specialists Scarborough Maine
United States Virginia Mason Seattle Main Clinic Seattle Washington
United States Regional Cancer Care Associates LLC - Sparta Sparta New Jersey
United States Scott and White Memorial Hospital Temple Texas
United States Prairie Lakes Health Care System INC Watertown South Dakota
United States Innovative Clinical Research Institute Whittier California

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Chile,  Colombia,  Czechia,  France,  Germany,  Hungary,  Italy,  Peru,  Poland,  Romania,  Spain,  Turkey,  United Kingdom, 

References & Publications (1)

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)

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) 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 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. 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
Secondary 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. Up to 135.4 weeks at the time of final analysis
Secondary 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. First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days
Secondary 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. First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days
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