A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer
NCT ID: NCT03694522
Last Updated: 2024-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
155 participants
INTERVENTIONAL
2018-09-14
2022-05-13
Brief Summary
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Detailed Description
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This study includes a Phase 1 safety run-in portion and a Phase 2 portion. The Phase 1 safety run-in is an open-label dose-escalation of bemarituzumab + mFOLFOX6 in patients with GI tumors (not FGFR2 selected) that is reported separately (NCT03343301).
The Phase 2 portion of the study (to follow the Phase 1 safety run-in) is described in this record.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bemarituzumab + mFOLFOX6
Participants received 15 mg/kg bemarituzumab administered every 2 weeks (Q2W) with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Bemarituzumab
Administered by intravenous infusion over approximately 30 minutes
Modified FOLFOX6
mFOLFOX6 regimen consists of the following:
* Oxaliplatin 85 mg/m² IV infusion over 120 minutes
* Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable
* 5-fluorouracil (5-FU) 400 mg/m² bolus over approximately 5 minutes then 5-FU 2400 mg/m² as a continuous IV infusion over approximately 48 hours
Placebo + mFOLFOX6
Participants received placebo for bemarituzumab administered every 2 weeks with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Placebo
Administered by intravenous infusion over approximately 30 minutes
Modified FOLFOX6
mFOLFOX6 regimen consists of the following:
* Oxaliplatin 85 mg/m² IV infusion over 120 minutes
* Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable
* 5-fluorouracil (5-FU) 400 mg/m² bolus over approximately 5 minutes then 5-FU 2400 mg/m² as a continuous IV infusion over approximately 48 hours
Interventions
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Bemarituzumab
Administered by intravenous infusion over approximately 30 minutes
Placebo
Administered by intravenous infusion over approximately 30 minutes
Modified FOLFOX6
mFOLFOX6 regimen consists of the following:
* Oxaliplatin 85 mg/m² IV infusion over 120 minutes
* Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable
* 5-fluorouracil (5-FU) 400 mg/m² bolus over approximately 5 minutes then 5-FU 2400 mg/m² as a continuous IV infusion over approximately 48 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Adequate hematological, liver and kidney function. Measurable or non-measurable, but evaluable disease using RECIST v1.1
* Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by a centrally performed immunohistochemistry tissue test and/or FGFR2 gene amplification as determined by a centrally performed circulating tumor deoxyribonucleic acid (ctDNA) blood based assay
* Candidate for mFOLFOX6 chemotherapy
Exclusion Criteria
* Clinically significant cardiac disease,
* Peripheral sensory neuropathy \>/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
* Active infection requiring systemic treatment
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
* Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
* Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
* Known positivity for human epidermal growth factor receptor 2 (HER2)
* Women who are pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Zai Lab (Shanghai) Co., Ltd.
INDUSTRY
Five Prime Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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University of Arizona Cancer Center
Tucson, Arizona, United States
The Oncology Institute of Tuscon
Tucson, Arizona, United States
Marin Cancer Care, Inc-California Cancer Care A Medical Group, Inc
Greenbrae, California, United States
Sutter Medical Group
Sacramento, California, United States
UCLA Medical Centre - Santa Monica Hematology and Oncology
Santa Monica, California, United States
Innovative Clinical Research Institute (ICRI)
Whittier, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut
Plainville, Connecticut, United States
University of Chicago
Chicago, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Oschsner Clinic Foundation
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Josephine Ford Cancer Center-Henry Ford Cancer Center
Detroit, Michigan, United States
Summit Medical Group. Morristown Oncology
Morristown, New Jersey, United States
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)
Rochester, New York, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
Westchester Institute For Treatment Of Cancer & Blood Disorders
White Plains, New York, United States
UNC- Chapel Hill
Chapel Hill, North Carolina, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, United States
St. Luke's Physician Group - St. Luke's Cancer Care Associates
Bethlehem, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Arlington Cancer Center
Arlington, Texas, United States
Utah Cancer Specialists (Intermountain Hematology - Oncology Associates) UCS Cancer Center
South Salt Lake, Utah, United States
Virginia Mason Seattle Main Clinic
Seattle, Washington, United States
Chris O'brien Lifehouse
Camperdown, , Australia
The Townsville Hospital
Douglas, , Australia
Sydney Adventist Hospital
Wahroonga, , Australia
AZ Sint Jan
Bruges, , Belgium
CH de l'Ardenne
Libramont, , Belgium
CHC Clinique Saint-Joseph
Liège, , Belgium
CHU UCL Namur, site Godinne
Yvoir, , Belgium
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Shiyan Taihe Hospital
Shiyan, Hubei, China
Wuhan Union Hospital of China
Wuhan, Hubei, China
The 81st Hospital of Chinese PLA
Nanjing, Jiangsu, China
Beijing Cancer Hospital
Beijing, , China
Chinese PLA General Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Sino Japanese Friendship Hospital of Jilin University
Changchun, , China
Hunan Cancer Hospital
Changsha, , China
Xiangya Hospital of Central South University
Changsha, , China
Chongqing Daping Hospital
Chongqing, , China
Fujian Cancer Hospital
Fuzhou, , China
The First Affiliated Hospital, Zhejiang University
Hangzhou, , China
Sir Run Run Shaw Hospital
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hopsital
Harbin, , China
Nanton Tumor Hospital
Nantong, , China
Shanghai East Hospital
Shanghai, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Ruijin Hospital Affiliated to Shanghai Jiatong University School of Medicine
Shanghai, , China
Cancer Hospital of Shantou University Medical College
Shantou, , China
Liaoning Cancer Hospital
Shenyang, , China
Fourth Hospital of Hebei Medical University
Shijiazhuang, , China
The Second Affiliated Hospital of Soochow University
Suzhou, , China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Henan Cancer Hospital
Zhengzhou, , China
CHRU Jean MINJOZ
Besançon, , France
Chu Morvan - Institut de Cancerologie
Brest, , France
Hopital Nord France Comte - Site Le Mittan
Montbéliard, , France
Polyclinique de Gentilly
Nancy, , France
CHU de Saint Etienne
Saint-Etienne, , France
Centre de Radiotherapie - Clinique Sainte Anne
Strasbourg, , France
Centre Paul Strauss
Strasbourg, , France
Klinik fur Innere Medizin, Shwerpunkt Gastroenterologie, Hamatologie, Onkologie, Nephrologie
Berlin, , Germany
Stadtisches Klinikum Braunschweig
Braunschweig, , Germany
Krankenhaus Nordwest gGmbH, Institut fur Klinisch-Onkologische Forschung
Frankfurt am Main, , Germany
Klinikum Ludwigsburg
Ludwigsburg, , Germany
Universitatsmedizin Manheim, II. Medizinische Klinik
Mannheim, , Germany
Klinikum Ostalb, Stauferklinikum Schwabisch Gmund, Zentrum fur Innere Medizin
Mutlangen, , Germany
Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik I
Oberpfalz, , Germany
National Institute of Oncology
Budapest, , Hungary
Del-Pesti Centrumkorhaz - Orszangos Hematologiai es Infektologiai Intezet, Onkologiai Osztaly
Budapest, , Hungary
Sugarterapias es Klinikai Onkologaiai Intezet B-A-Z Megyei Korhaz
Miskolc, , Hungary
Josa Andras Teaching Hospital
Nyíregyháza, , Hungary
University of Pecs, Clinic of Oncotherapy
Pécs, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet
Szolnok, , Hungary
AOU Ospedall Riuniti Umberto
Ancona, , Italy
AO "S.G. Moscati"
Avellino, , Italy
Centro di Riferimento Oncologico
Aviano, , Italy
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
Brescia, , Italy
Istituto di Ricovero e Cura a Carattere Scientifico - IRCCS di Candiolo
Candiolo, , Italy
Azienda Socio-Sanitaria Territoriale di Cremona
Cremona, , Italy
Azienda Ospedaliero Universitaria Caregg - I S.O.D. Oncologia Medica
Florence, , Italy
Ospedale Policlinico S. Martino
Genova, , Italy
Ospedale Generale Mater Salutis" - Azienda ULSS n. 21 di Legnago
Legnago, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Servizio Oncologia Medica ed Ematologia, AOU dell'Universita
Napoli, , Italy
Fondazione Irccs Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Policlinico Universitario Campus Bio-Medico di Roma
Roma, , Italy
Fondazione IRCSS Casa Sollievo Della Sofferenza
San Giovanni Rotondo, , Italy
ASST della Valtellina e dell'Alto Lario - PO di Sondrio
Sondrio, , Italy
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
Torino, , Italy
Azienda Sanitaria Universitaria Integrata de Udine
Udine, , Italy
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō City, , Japan
Hiroshima Citizens Hospital
Hiroshima, , Japan
St. Marianna University School of Medicine Hospital
Kawasaki, , Japan
Japan Community Health Care Organization Kyushu Hospital
Kitakyushu, , Japan
The Cancer Institute Hospital of JFCR
Kōtoku, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Hyogo College of Medicine College Hospital
Nishinomiya, , Japan
Osaka General Medical Center
Osaka, , Japan
Osaka Medical College Hospital
Osaka, , Japan
Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II w Bielsku-Bialej
Bielsko-Biala, , Poland
Szpital Specjalistyczny w Brzozowie, Podkarpacki Osrodek Onkologiczny
Brzozów, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
Lublin, , Poland
SP ZOZ Ministerstwa Spraw Wewnetrznych z Warminsko - Mazurskim Centrum Onkologii
Olsztyn, , Poland
Europejskie Centrum Zdrowia Otwock Szpital im. F. Chopina
Otwock, , Poland
Lekarz Beata Madej Mruk I Partner. Spolka Partnerska Oddzial nr 1 w Rzesowie
Rzeszów, , Poland
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej
Warsaw, , Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Onkologi I Radioterapii
Warsaw, , Poland
Centro Hospitalar do Baixo Vouga, EPE
Aveiro, , Portugal
Hospital de Braga
Braga, , Portugal
Hospital Senhora Da Oliveira EPE
Guimarães, , Portugal
Centro Hospitalar Universitario do Porto E.P.E
Porto, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E
Porto, , Portugal
Centro Hospitalar de Entre o Douro e Vouga EPE
Santa Maria da Feira, , Portugal
Unidade Local de Saude de Matosinhos EPE
Senhora da Hora, , Portugal
Institutul Clinic Fundeni - Clinica Pediatrie
Bucharest, , Romania
Institutul Oncologic, Prof. Dr. I. Chiricuta Cluj-Napoca
Cluj-Napoca, , Romania
S.C. Medisprof S.R.L
Cluj-Napoca, , Romania
Spitalul Clinic Judetean de Urgenta ,,Sf. Apostol Andrei" Constanta, Clinica Oncologie Medicala
Constanța, , Romania
S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala
Craiova, , Romania
SC Oncolab SRL, Oncologie
Craiova, , Romania
S.C. Oncocenter Oncologie Clinica S.R.L
Timișoara, , Romania
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Gangnam, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Kyungpook National University Chilgok Hospital
Daegu, Gyeongsangbuk-do, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-gu, South Korea
Dong-A University Hospital
Busan, , South Korea
Chungnam National University Hospital (CNUH)
Daejeon, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Yonsei University Health System
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Complejo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Duran I Reynals - Instituto Catalan de Oncologia
Barcelona, , Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, , Spain
Hospital General de Catalunya
Barcelona, , Spain
Institut Catala d'Oncologia - Hospital Doctor Josep Trueta
Girona, , Spain
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Complejo Hospital De Navarra
Pamplona, , Spain
Corporacio Sanitaria Parc Tauli
Sabadell, , Spain
Hosptial Universitario Virgen Macarena
Servilla, , Spain
Hospital Universitario Mutua de Terrassa
Terrassa, , Spain
China Medical University Hospital
Taichung, , Taiwan
Faculty of Medicine, Chulalongkorn University
Bangkok, , Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, , Thailand
Faculty of Medicine, Prince of Sonkla University
Hat Yai, , Thailand
Khon Kaen Hospital
Khon Kaen, , Thailand
Lampang Cancer Hospital
Lampang, , Thailand
Cukurova University Faculty of Medicine Paediatric Nephrology
Adana, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Ankara Oncology Education and Research Hospital
Ankara, , Turkey (Türkiye)
Ondokuz Mayis University Medicine Faculty
Atakum, , Turkey (Türkiye)
Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi
Aydin, , Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi
Bursa, , Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi, Sahinbey Onkoloji Hastanesi
Gaziantep, , Turkey (Türkiye)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, , Turkey (Türkiye)
Istanbul Madeniyet Universitesi Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Medical Park Izmir Hastanesi
Izmir, , Turkey (Türkiye)
Ege University Hopsital
Izmir, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, , Turkey (Türkiye)
Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi
Malatya, , Turkey (Türkiye)
Yuzuncuyil Universitesi Tip Fakultesi
Van, , Turkey (Türkiye)
Ninewells Hospital and Medical School
Dundee, , United Kingdom
Countries
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References
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Wainberg ZA, Kang YK, Lee KW, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Zahlten-Kumeli A, Taylor K, Enzinger PC. Bemarituzumab as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: final analysis of the randomized phase 2 FIGHT trial. Gastric Cancer. 2024 May;27(3):558-570. doi: 10.1007/s10120-024-01466-w. Epub 2024 Feb 3.
Wainberg ZA, Enzinger PC, Kang YK, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Borg C, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Collins H, Mitra S, Yang Y, Catenacci DVT, Lee KW. Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): a randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2022 Nov;23(11):1430-1440. doi: 10.1016/S1470-2045(22)00603-9. Epub 2022 Oct 14.
Xiang H, Liu L, Gao Y, Ahene A, Macal M, Hsu AW, Dreiling L, Collins H. Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial. Cancer Chemother Pharmacol. 2020 Nov;86(5):595-606. doi: 10.1007/s00280-020-04139-4. Epub 2020 Sep 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003507-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20210113
Identifier Type: OTHER
Identifier Source: secondary_id
FPA144-004 Phase 2
Identifier Type: -
Identifier Source: org_study_id
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