Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- Conditions
- Gastric Adenocarcinoma
- Interventions
- Registration Number
- NCT02545504
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 432
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles Placebo 5-fluorouracil Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles Placebo Oxaliplatin Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles Andecaliximab Leucovorin Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles Andecaliximab 5-fluorouracil Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles Andecaliximab Oxaliplatin Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles Placebo Leucovorin Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles Andecaliximab Andecaliximab Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 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.
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS) 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.
Objective Response Rate (ORR) 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.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) 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.
Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities 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.
Trial Locations
- Locations (134)
Instituto Clinico Oncologico del Sur
🇨🇱Temuco, Chile
Centro Medico monte Carmelo
🇵🇪Arequipa, Peru
The Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
University of Rochester
🇺🇸Rochester, New York, United States
Hospital Clinico Vina Del Mar
🇨🇱Vina del Mar, Chile
Hospital Pablo Tobon Uribe
🇨🇴Medellin, Colombia
Medisprof srl Oncologie P TA
🇷🇴Cluj-Napoca, Judet Cluj, Romania
Centrul de Oncologie Sfantul Nectarie SRL, Oncologie
🇷🇴Craiova, Romania
Spitalul Judetean De Urgenta Sf Ion Cel Nou Suceava Sectia Oncologie Medicala Bdul
🇷🇴Suceava, Romania
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Kliniken Nordoberpfalz AG
🇩🇪Weiden, Bavaria, Germany
Hacettepe University
🇹🇷Ankara, Turkey
Christie Hospital NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Kocaeli Universty
🇹🇷Kocaeli, Turkey
Van Yuzuncu Yil Universitesi Tip Kaultesi Ic Hastaliklari Anabilim Dali Tibbi Okoloji Bilim Dali
🇹🇷Van, Turkey
New England Cancer Specialists
🇺🇸Scarborough, Maine, United States
Oncology Hematology Care, Inc.
🇺🇸Cincinnati, Ohio, United States
Edward Hospital & Health Services
🇺🇸Naperville, Illinois, United States
Indiana University Goshen Center for Cancer Care
🇺🇸Goshen, Indiana, United States
Cancer Center of Central Connecticut
🇺🇸Plainville, Connecticut, United States
Omega Research Consultants LLC
🇺🇸DeBary, Florida, United States
Charleston Hematology Oncology Associates
🇺🇸Charleston, South Carolina, United States
Prairie Lakes Health Care System INC
🇺🇸Watertown, South Dakota, United States
Hôpitaux Civils de Colmar
🇫🇷Colmar, France
Center for Cancer Blood Disorders
🇺🇸Fort Worth, Texas, United States
CHU Jean Minjoz
🇫🇷Besancon, France
Texas Oncology-Seton Williamson
🇺🇸Round Rock, Texas, United States
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Klinikum rechts der Isar Technical University of Ismaninger
🇩🇪Munich, Bayern, Germany
Oncomedica S.A
🇨🇴Monteria, Cordoba, Colombia
Dundacion Oftalmologica de Santander Clinica Ardila Lulle La Foscal
🇨🇴Floridablanca, Colombia
The Crown Princess Mary Cancer Centre
🇦🇺Westmead, New South Wales, Australia
CHRU de Brest, Hopital Morvan, Institut de Cancerologie et d'Hematologie
🇫🇷Brest Cedex, France
Epworth Healthcare
🇦🇺Richmond, Victoria, Australia
Human Klinikai Vizsgalatok Regisztracios Kozpont - HKVRK
🇭🇺Gyor, Hungary
Centro Medico Imbanaco de Cali S.A
🇨🇴Valle, Colombia
University Hospital Gent Department of Gastroenterology
🇧🇪Gent, Belgium
Ente Ospedaliero Ospedali Galliera
🇮🇹Genova, Italy
CHU de Nice-l Archet
🇫🇷Nice Cedex 3, France
University Hospital - Czech
🇨🇿Olomouc, Czechia
Zala Megyei Korhaz Pozva Diabetes Kulsokorhaz
🇭🇺Zalaegerszeg, Hungary
CH Annecy-Gennevois
🇫🇷Pringy Cedex, France
Instituto Nacional Del Cancer
🇨🇱Santiago, Chile
Fakultni Nemocnice Brno
🇨🇿Brno, Czechia
Borsod County Hospital Clinical Oncological and Radiotheraputic Center
🇭🇺Miskolc, Hungary
Oblastni Nemocnice Pribram
🇨🇿Pribram, Czechia
IRCCS A.O.U. San Martino
🇮🇹Genova, Italy
DRK Klinken Berlin Abteilungsleiter Chiurgische Okologie
🇩🇪Berlin, Germany
Universitätsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Cancer Center Heilbronn-Franken, SLK-Kliniken
🇩🇪Heilbronn, Germany
Staedtisches Klinikum Muenchen Bogenhausen
🇩🇪Muenchen, Germany
Krankenhaus Nordwest gGmbH Institut für Klinisch Onkologische Med Klinik II
🇩🇪Frankfurt, Germany
Kliniken Essen Mitte Studiensekretariat Onkologie Evang. Huyssens-Stiftung
🇩🇪Essen, Germany
Universitatsklinikum Ulm
🇩🇪Ulm, Germany
Zentrum fur Innere Medizin Stauferklinikum Schwab
🇩🇪Mutlangen, Germany
University Hospital Company of Pisana
🇮🇹Pisa, PI, Italy
Pandy Kalman Hospital
🇭🇺Gyula, Hungary
Debreceni Egyetem Klinikai Központ
🇭🇺Debrecen, Hungary
Trakya University
🇹🇷Edirne, Turkey
Bezmialem University Hospital
🇹🇷Istanbul, Turkey
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Del Mar Servicio de Oncologia
🇪🇸Barcelona, Spain
Ospedale San Raffaele
🇮🇹Milano, Italy
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
Centro de Investigacion Instituto de oncologia y Radiotherpia de la Clinica
🇵🇪San Isidro, Lima, Peru
Cukurova Universitesi
🇹🇷Adana, Turkey
Ankara University Medical Faculty Ibni Sina Hospital
🇹🇷Ankara, Turkey
Marmara University
🇹🇷Kadikoy, Turkey
Hospital Universitario Morales Meseguer
🇪🇸Murcia, Spain
Royal Marsden Hospital Mulberry House
🇬🇧London, United Kingdom
Peterborough City Hospital Peterborough and Stamford Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Hospital Regional Universitario de Malaga
🇪🇸Malaga, Spain
SC Centrul de Oncologie Euroclinic SRL, Oncologie
🇷🇴Iaşi, Romania
Wojewodzki Szpital Zespolony w Elblagu Oddzial Onkologiczny
🇵🇱Elblag, Poland
Klinka Gastroenterologii Okologicznej Centrum Okologii Instytut
🇵🇱Warszawa, Poland
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Clinica Anglo Americana Calle Alfredo Salazar
🇵🇪San Isidro, Peru
Beskidzkie Oncology Center
🇵🇱Bielsko-Biala, Poland
Mrukmed Lekarz Beata Madej Mruk i Partner Spolka Partnerska Oddzial Nr 1 w Rzeszowie
🇵🇱Rzeszow, Poland
GRAL Medical SRL
🇷🇴Bucuresti, Romania
Sc Oncolab Srl
🇷🇴Craiova, Romania
Institut Catala de la Salut
🇪🇸Barcelona, Spain
Hospital Universitario de A Coruna C
🇪🇸A Coruna, Spain
Hacettepe Universitesi Tip Facultesi Cocuk Saligi ve Hastaklikleri Anabilim Dali
🇹🇷Ankara, Turkey
Istanbul Universitesi Onkoloji Enstitusu Medikal Onkoloji Bilim Dali
🇹🇷Istanbul, Turkey
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
S.C. Oncologia Medica Azienda Ospedaliera Valtellina e Valchiavenna Presidio Ospedaliero di Sondrio
🇮🇹Sondrio, Italy
Izmir Universitesi Hastanesi Yeni Girne Vulvari
🇹🇷Karsiyaka, Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi Elazi
🇹🇷Malatya, Turkey
Institut Paoli Calmettes
🇫🇷Marseille Cedex 9, France
University College London
🇬🇧London, United Kingdom
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Spain
Hospital Virgen de Valme
🇪🇸Sevilla, Spain
Thomayer Hospital
🇨🇿Prague 4, Czechia
Innovative Clinical Research Institute
🇺🇸Whittier, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
UCLA Jonsson Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Parkview Hospital
🇺🇸Fort Wayne, Indiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Karamanos Cancer Institute
🇺🇸Detroit, Michigan, United States
HCA Healthcare
🇺🇸Kansas City, Missouri, United States
Regional Cancer Care Associates LLC - Sparta
🇺🇸Sparta, New Jersey, United States
Carol G. Simon Cancer Center
🇺🇸Morristown, New Jersey, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Northwest Cancer Specialists
🇺🇸Portland, Oregon, United States
Weill Cornell Medical College - New York Presbyterian Hospital
🇺🇸New York, New York, United States
The Ohio State Medical Center
🇺🇸Columbus, Ohio, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Scott and White Memorial Hospital
🇺🇸Temple, Texas, United States
Virginia Mason Seattle Main Clinic
🇺🇸Seattle, Washington, United States
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Ashford Cancer Centre
🇦🇺Kurralta Park, South Australia, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, 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 of Uludag
🇹🇷Bursa, Turkey
Azienda Ospedaliera Treviglio Caravaggio U.O. Oncologia Medica
🇮🇹Treviglio, Italy
Wojskowy Instytut Medyczny
🇵🇱Warsaw, Poland
Wielkopolskie Centrum Onkologii
🇵🇱Poznan, Poland
Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
🇵🇱Torun, Poland
Fundeni Clinical Institute
🇷🇴Bucuresti, Romania
Hospital Parc Tauli
🇪🇸Barcelona, Spain
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
🇹🇷Istanbul, Turkey
New Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Egyesített Szent István és Szent László Kórház -Rendelőintézet
🇭🇺Budapest, Hungary