Clinical trial NCT02545504: Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Adenocarcinoma
Keywords: Gastroesophageal junction (GEJ)
Stomach cancer
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-09-10
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 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:
measure: Progression-free Survival (PFS)
timeFrame: 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
measure: Objective Response Rate (ORR)
timeFrame: Up to 135.4 weeks at the time of final analysis
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days
measure: Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities
timeFrame: First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Plainville
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: DeBary
country: United States
facility: Omega Research Consultants LLC
state: Florida
city: Naperville
country: United States
facility: Edward Hospital & Health Services
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Hospital
state: Indiana
city: Goshen
country: United States
facility: Indiana University Goshen Center for Cancer Care
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Detroit
country: United States
facility: Karamanos Cancer Institute
state: Michigan
city: Kansas City
country: United States
facility: HCA Healthcare
state: Missouri
city: Morristown
country: United States
facility: Carol G. Simon Cancer Center
state: New Jersey
city: Sparta
country: United States
facility: Regional Cancer Care Associates LLC - Sparta
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College - New York Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Columbus
country: United States
facility: The Ohio State Medical Center
state: Ohio
city: Portland
country: United States
facility: Northwest Cancer Specialists
state: Oregon
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates
state: South Carolina
city: Watertown
country: United States
facility: Prairie Lakes Health Care System INC
state: South Dakota
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Fort Worth
country: United States
facility: Center for Cancer Blood Disorders
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Round Rock
country: United States
facility: Texas Oncology-Seton Williamson
state: Texas
city: Temple
country: United States
facility: Scott and White Memorial Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Seattle Main Clinic
state: Washington
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Westmead
country: Australia
facility: The Crown Princess Mary Cancer Centre
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Richmond
country: Australia
facility: Epworth Healthcare
state: Victoria
city: St Albans
country: Australia
facility: Western Health Sunshine Hospital
state: Victoria
city: Tweed Heads
country: Australia
facility: The Tweed Hospital
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
city: Libramont
country: Belgium
facility: Centre Hospitalizer De L'Ardenne
state: Chevigny
city: Gent
country: Belgium
facility: University Hospital Gent Department of Gastroenterology
city: Santiago
country: Chile
facility: Instituto Nacional Del Cancer
city: Temuco
country: Chile
facility: Instituto Clinico Oncologico del Sur
city: Vina del Mar
country: Chile
facility: Hospital Clinico Vina Del Mar
city: Monteria
country: Colombia
facility: Oncomedica S.A
state: Cordoba
city: Floridablanca
country: Colombia
facility: Dundacion Oftalmologica de Santander Clinica Ardila Lulle La Foscal
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Valle
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: University Hospital - Czech
city: Prague 4
country: Czechia
facility: Thomayer Hospital
city: Pribram
country: Czechia
facility: Oblastni Nemocnice Pribram
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Brest Cedex
country: France
facility: CHRU de Brest, Hopital Morvan, Institut de Cancerologie et d'Hematologie
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Marseille Cedex 9
country: France
facility: Institut Paoli Calmettes
city: Nice Cedex 3
country: France
facility: CHU de Nice-l Archet
city: Pringy Cedex
country: France
facility: CH Annecy-Gennevois
city: Weiden
country: Germany
facility: Kliniken Nordoberpfalz AG
state: Bavaria
city: Munich
country: Germany
facility: Klinikum rechts der Isar Technical University of Ismaninger
state: Bayern
city: Berlin
country: Germany
facility: DRK Klinken Berlin Abteilungsleiter Chiurgische Okologie
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Essen
country: Germany
facility: Kliniken Essen Mitte Studiensekretariat Onkologie Evang. Huyssens-Stiftung
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest gGmbH Institut für Klinisch Onkologische Med Klinik II
city: Heilbronn
country: Germany
facility: Cancer Center Heilbronn-Franken, SLK-Kliniken
city: Muenchen
country: Germany
facility: Staedtisches Klinikum Muenchen Bogenhausen
city: Mutlangen
country: Germany
facility: Zentrum fur Innere Medizin Stauferklinikum Schwab
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Budapest
country: Hungary
facility: Egyesített Szent István és Szent László Kórház -Rendelőintézet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
city: Gyor
country: Hungary
facility: Human Klinikai Vizsgalatok Regisztracios Kozpont - HKVRK
city: Gyula
country: Hungary
facility: Pandy Kalman Hospital
city: Miskolc
country: Hungary
facility: Borsod County Hospital Clinical Oncological and Radiotheraputic Center
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz Pozva Diabetes Kulsokorhaz
city: Pisa
country: Italy
facility: University Hospital Company of Pisana
state: PI
city: Genova
country: Italy
facility: Ente Ospedaliero Ospedali Galliera
city: Genova
country: Italy
facility: IRCCS A.O.U. San Martino
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Sondrio
country: Italy
facility: S.C. Oncologia Medica Azienda Ospedaliera Valtellina e Valchiavenna Presidio Ospedaliero di Sondrio
city: Treviglio
country: Italy
facility: Azienda Ospedaliera Treviglio Caravaggio U.O. Oncologia Medica
city: San Isidro
country: Peru
facility: Centro de Investigacion Instituto de oncologia y Radiotherpia de la Clinica
state: Lima
city: Arequipa
country: Peru
facility: Centro Medico monte Carmelo
city: San Isidro
country: Peru
facility: Clinica Anglo Americana Calle Alfredo Salazar
city: Bielsko-Biala
country: Poland
facility: Beskidzkie Oncology Center
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony w Elblagu Oddzial Onkologiczny
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii
city: Rzeszow
country: Poland
facility: Mrukmed Lekarz Beata Madej Mruk i Partner Spolka Partnerska Oddzial Nr 1 w Rzeszowie
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny
city: Warszawa
country: Poland
facility: Klinka Gastroenterologii Okologicznej Centrum Okologii Instytut
city: Cluj-Napoca
country: Romania
facility: Medisprof srl Oncologie P TA
state: Judet Cluj
city: Bucuresti
country: Romania
facility: Fundeni Clinical Institute
city: Bucuresti
country: Romania
facility: GRAL Medical SRL
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie SRL, Oncologie
city: Craiova
country: Romania
facility: Sc Oncolab Srl
city: Iaşi
country: Romania
facility: SC Centrul de Oncologie Euroclinic SRL, Oncologie
city: Suceava
country: Romania
facility: Spitalul Judetean De Urgenta Sf Ion Cel Nou Suceava Sectia Oncologie Medicala Bdul
city: A Coruna
country: Spain
facility: Hospital Universitario de A Coruna C
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Del Mar Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Parc Tauli
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Institut Catala de la Salut
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Murcia
country: Spain
facility: Hospital Universitario Morales Meseguer
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Sevilla
country: Spain
facility: Hospital Virgen de Valme
city: Adana
country: Turkey
facility: Cukurova Universitesi
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty Ibni Sina Hospital
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Facultesi Cocuk Saligi ve Hastaklikleri Anabilim Dali
city: Ankara
country: Turkey
facility: Hacettepe University
city: Bursa
country: Turkey
facility: University of Uludag
city: Edirne
country: Turkey
facility: Trakya University
city: Istanbul
country: Turkey
facility: Bezmialem University Hospital
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Onkoloji Enstitusu Medikal Onkoloji Bilim Dali
city: Kadikoy
country: Turkey
facility: Marmara University
city: Karsiyaka
country: Turkey
facility: Izmir Universitesi Hastanesi Yeni Girne Vulvari
city: Kocaeli
country: Turkey
facility: Kocaeli Universty
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Tip Merkezi Elazi
city: Van
country: Turkey
facility: Van Yuzuncu Yil Universitesi Tip Kaultesi Ic Hastaliklari Anabilim Dali Tibbi Okoloji Bilim Dali
city: Birmingham
country: United Kingdom
facility: New Queen Elizabeth Hospital
city: Cambridge
country: United Kingdom
facility: Peterborough City Hospital Peterborough and Stamford Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Marsden Hospital Mulberry House
city: London
country: United Kingdom
facility: University College London
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
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.