AzTrials
AzTrials

Gastric CancerPhase 2FIGHTNCT03694522

A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer

A Phase 2 study testing Bemarituzumab and Modified FOLFOX6 in people with Gastric Cancer, run by Five Prime Therapeutics, Inc. at 189 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Bemarituzumab and Modified FOLFOX6
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
155 participants
Where
189 sitesin 18 countries
Study dates
14 Sep 2018to 13 May 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not amenable to curative therapy)
  • 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

Who cannot join

  • Untreated or symptomatic central nervous system (CNS) metastases
  • 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
Show all 10Show fewer
  • 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
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

189 sites in 18 countries.

189 sites in 18 countries

United States29 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • St. Luke's Physician Group - St. Luke's Cancer Care Associates

    Bethlehem, Pennsylvania, 18015

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • UNC- Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29435

  • University of Chicago

    Chicago, Illinois, 60637

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Josephine Ford Cancer Center-Henry Ford Cancer Center

    Detroit, Michigan, 48202

  • Marin Cancer Care, Inc-California Cancer Care A Medical Group, Inc

    Greenbrae, California, 94904

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

  • Summit Medical Group. Morristown Oncology

    Morristown, New Jersey, 07960

  • Yale Cancer Center

    New Haven, Connecticut, 06519

  • Oschsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut

    Plainville, Connecticut, 06062

  • University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)

    Rochester, New York, 14642

  • Sutter Medical Group

    Sacramento, California, 95816

  • UCLA Medical Centre - Santa Monica Hematology and Oncology

    Santa Monica, California, 90404

  • Virginia Mason Seattle Main Clinic

    Seattle, Washington, 98101

  • Utah Cancer Specialists (Intermountain Hematology - Oncology Associates) UCS Cancer Center

    South Salt Lake, Utah, 84106

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • The Oncology Institute of Tuscon

    Tucson, Arizona, 85745

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • University of Kansas Medical Center

    Westwood, Kansas, 66205

  • Westchester Institute For Treatment Of Cancer & Blood Disorders

    White Plains, New York, 10601

  • Innovative Clinical Research Institute (ICRI)

    Whittier, California, 90603

Other trials in United States

China26 sites

  • Beijing Cancer Hospital

    Beijing, 100412

  • Chinese PLA General Hospital

    Beijing

  • The First Hospital of Jilin University

    Changchun, 130021

  • Sino Japanese Friendship Hospital of Jilin University

    Changchun, 130033

  • Hunan Cancer Hospital

    Changsha, 410006

  • Xiangya Hospital of Central South University

    Changsha

  • Chongqing Daping Hospital

    Chongqing, 400000

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, 310003

  • Sir Run Run Shaw Hospital

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Harbin Medical University Cancer Hopsital

    Harbin

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

  • The 81st Hospital of Chinese PLA

    Nanjing, Jiangsu, 210002

  • Nanton Tumor Hospital

    Nantong

  • Shanghai East Hospital

    Shanghai, 200123

  • Fudan University Shanghai Cancer Center

    Shanghai, 210032

  • Ruijin Hospital Affiliated to Shanghai Jiatong University School of Medicine

    Shanghai

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515041

  • Liaoning Cancer Hospital

    Shenyang, 110042

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang

  • Shiyan Taihe Hospital

    Shiyan, Hubei, 442000

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

  • Wuhan Union Hospital of China

    Wuhan, Hubei, 430000

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Italy19 sites

  • AOU Ospedall Riuniti Umberto

    Ancona, 60020

  • AO "S.G. Moscati"

    Avellino

  • Centro di Riferimento Oncologico

    Aviano, 33081

  • Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

    Brescia

  • Istituto di Ricovero e Cura a Carattere Scientifico - IRCCS di Candiolo

    Candiolo, 10060

  • Azienda Socio-Sanitaria Territoriale di Cremona

    Cremona, 26100

  • Azienda Ospedaliero Universitaria Caregg - I S.O.D. Oncologia Medica

    Florence

  • Ospedale Policlinico S. Martino

    Genova, 16132

  • Ospedale Generale Mater Salutis" - Azienda ULSS n. 21 di Legnago

    Legnago, 37045

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Servizio Oncologia Medica ed Ematologia, AOU dell'Universita

    Naples, 80131

  • Fondazione Irccs Policlinico San Matteo

    Pavia

  • Azienda Ospedaliera Universitaria Pisana

    Pisa

  • Policlinico Universitario Campus Bio-Medico di Roma

    Roma

  • Fondazione IRCSS Casa Sollievo Della Sofferenza

    San Giovanni Rotondo

  • ASST della Valtellina e dell'Alto Lario - PO di Sondrio

    Sondrio

  • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

    Torino

  • Azienda Sanitaria Universitaria Integrata de Udine

    Udine, 33100

Other trials in Italy

Spain17 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Duran I Reynals - Instituto Catalan de Oncologia

    Barcelona, 08908

  • Hospital de la Santa Creu I Sant Pau

    Barcelona

  • Hospital General de Catalunya

    Barcelona

  • Institut Catala d'Oncologia - Hospital Doctor Josep Trueta

    Girona, 17007

  • Hospital Universitari Arnau de Vilanova

    Lleida

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital General Universitario Gregorio Maranon

    Madrid

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Complejo Hospital De Navarra

    Pamplona, 31008

  • Corporacio Sanitaria Parc Tauli

    Sabadell

  • Hosptial Universitario Virgen Macarena

    Servilla, 41009

  • Hospital Universitario Mutua de Terrassa

    Terrassa, 08221

Other trials in Spain

South Korea16 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14068

  • Dong-A University Hospital

    Busan, 49201

  • Kyungpook National University Chilgok Hospital

    Daegu, Gyeongsangbuk-do

  • Chungnam National University Hospital (CNUH)

    Daejeon, 35015

  • Gachon University Gil Medical Center

    Incheon, Namdong-gu, 21565

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do, 54907

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, Gangnam, 06273

  • Korea University Anam Hospital

    Seoul, 02841

  • Yonsei University Health System

    Seoul, 03722

  • Kangbuk Samsung Hospital

    Seoul, 04514

  • Asan Medical Center

    Seoul, 05505

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 08308

  • Seoul National University Hospital

    Seoul, 3080

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Turkey (Türkiye)15 sites

  • Cukurova University Faculty of Medicine Paediatric Nephrology

    Adana

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06100

  • Ankara Oncology Education and Research Hospital

    Ankara, 06200

  • Ondokuz Mayis University Medicine Faculty

    Atakum, 55200

  • Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi

    Aydin, 09100

  • Uludag Universitesi Tip Fakultesi

    Bursa, 16059

  • Gaziantep Universitesi Tip Fakultesi, Sahinbey Onkoloji Hastanesi

    Gaziantep

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34093

  • Istanbul Madeniyet Universitesi Tip Fakultesi

    Istanbul

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul

  • Medical Park Izmir Hastanesi

    Izmir, 35575

  • Ege University Hopsital

    Izmir

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

  • Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi

    Malatya, 44300

  • Yuzuncuyil Universitesi Tip Fakultesi

    Van, 65080

Other trials in Turkey (Türkiye)

Japan11 sites

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyō City

  • Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • St. Marianna University School of Medicine Hospital

    Kawasaki, 216-8511

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793

  • Japan Community Health Care Organization Kyushu Hospital

    Kitakyushu

  • The Cancer Institute Hospital of JFCR

    Kōtoku

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Hyogo College of Medicine College Hospital

    Nishinomiya, 663-8501

  • Osaka General Medical Center

    Osaka, 558-8558

  • Osaka Medical College Hospital

    Osaka, 569-8686

Other trials in Japan

Poland8 sites

  • Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II w Bielsku-Bialej

    Bielsko-Biala, 43-300

  • Szpital Specjalistyczny w Brzozowie, Podkarpacki Osrodek Onkologiczny

    Brzozów, 36-200

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

    Lublin

  • SP ZOZ Ministerstwa Spraw Wewnetrznych z Warminsko - Mazurskim Centrum Onkologii

    Olsztyn, 10-228

  • Europejskie Centrum Zdrowia Otwock Szpital im. F. Chopina

    Otwock, 05-400

  • Lekarz Beata Madej Mruk I Partner. Spolka Partnerska Oddzial nr 1 w Rzesowie

    Rzeszów, 35-021

  • Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej

    Warsaw, 04-141

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Onkologi I Radioterapii

    Warsaw

Other trials in Poland

France7 sites

  • CHRU Jean MINJOZ

    Besançon, 25000

  • Chu Morvan - Institut de Cancerologie

    Brest

  • Hopital Nord France Comte - Site Le Mittan

    Montbéliard, 25200

  • Polyclinique de Gentilly

    Nancy

  • CHU de Saint Etienne

    Saint-Etienne, 42055

  • Centre de Radiotherapie - Clinique Sainte Anne

    Strasbourg, 67000

  • Centre Paul Strauss

    Strasbourg

Other trials in France

Germany7 sites

  • Klinik fur Innere Medizin, Shwerpunkt Gastroenterologie, Hamatologie, Onkologie, Nephrologie

    Berlin, 12559

  • Stadtisches Klinikum Braunschweig

    Braunschweig, 38114

  • Krankenhaus Nordwest gGmbH, Institut fur Klinisch-Onkologische Forschung

    Frankfurt am Main, 60488

  • Klinikum Ludwigsburg

    Ludwigsburg, 71640

  • Universitatsmedizin Manheim, II. Medizinische Klinik

    Mannheim

  • Klinikum Ostalb, Stauferklinikum Schwabisch Gmund, Zentrum fur Innere Medizin

    Mutlangen

  • Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik I

    Oberpfalz, 92637

Other trials in Germany

Portugal7 sites

  • Centro Hospitalar do Baixo Vouga, EPE

    Aveiro, 3814-501

  • Hospital de Braga

    Braga, 4710-243

  • Hospital Senhora Da Oliveira EPE

    Guimarães

  • Centro Hospitalar Universitario do Porto E.P.E

    Porto, 4099-011

  • Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E

    Porto

  • Centro Hospitalar de Entre o Douro e Vouga EPE

    Santa Maria da Feira

  • Unidade Local de Saude de Matosinhos EPE

    Senhora da Hora

Other trials in Portugal

Romania7 sites

  • Institutul Clinic Fundeni - Clinica Pediatrie

    Bucharest, 022328

  • Institutul Oncologic, Prof. Dr. I. Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015

  • S.C. Medisprof S.R.L

    Cluj-Napoca, 400641

  • Spitalul Clinic Judetean de Urgenta ,,Sf. Apostol Andrei" Constanta, Clinica Oncologie Medicala

    Constanța, 900591

  • S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala

    Craiova, 200347

  • SC Oncolab SRL, Oncologie

    Craiova, 200385

  • S.C. Oncocenter Oncologie Clinica S.R.L

    Timișoara, 300166

Other trials in Romania

Hungary6 sites

  • National Institute of Oncology

    Budapest, 1122

  • Del-Pesti Centrumkorhaz - Orszangos Hematologiai es Infektologiai Intezet, Onkologiai Osztaly

    Budapest

  • Sugarterapias es Klinikai Onkologaiai Intezet B-A-Z Megyei Korhaz

    Miskolc

  • Josa Andras Teaching Hospital

    Nyíregyháza, 4400

  • University of Pecs, Clinic of Oncotherapy

    Pécs, 7624

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet

    Szolnok, 5000

Other trials in Hungary

Thailand5 sites

  • Faculty of Medicine, Chulalongkorn University

    Bangkok

  • Chiangrai Prachanukroh Hospital

    Chiang Rai

  • Faculty of Medicine, Prince of Sonkla University

    Hat Yai, 90110

  • Khon Kaen Hospital

    Khon Kaen

  • Lampang Cancer Hospital

    Lampang

Other trials in Thailand

Belgium4 sites

  • AZ Sint Jan

    Bruges

  • CH de l'Ardenne

    Libramont, 6800

  • CHC Clinique Saint-Joseph

    Liège, 04000

  • CHU UCL Namur, site Godinne

    Yvoir, 05530

Other trials in Belgium

Australia3 sites

  • Chris O'brien Lifehouse

    Camperdown

  • The Townsville Hospital

    Douglas

  • Sydney Adventist Hospital

    Wahroonga

Other trials in Australia

Taiwan1 site

  • China Medical University Hospital

    Taichung, 40447

Other trials in Taiwan

United Kingdom1 site

  • Ninewells Hospital and Medical School

    Dundee, DD198Y

Other trials in United Kingdom

About this study

Official title: FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1

The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer.

Read the detailed description

Study FPA144-004 is a phase 1/2, multicenter, global, double-blind, randomized, controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of bemarituzumab in combination with mFOLFOX6, compared with placebo in combination with mFOLFOX6, in adults with unresectable, locally advanced, or metastatic gastric cancer including cancer of the gastroesophageal junction (GEJ).

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
Gastric Cancer
Being tested
Bemarituzumab, Placebo, Modified FOLFOX6
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BemarituzumabBiological

    Also called FPA144, AMG 552

    Administered by intravenous infusion over approximately 30 minutes

  • PlaceboDrug

    Administered by intravenous infusion over approximately 30 minutes

  • Modified FOLFOX6Drug

    Also called mFOLFOX6

    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
Study groups in NCT03694522
Study groupRoleWhat they receive
Bemarituzumab + mFOLFOX6ExperimentalParticipants 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.
Receives: Biological: Bemarituzumab; Drug: Modified FOLFOX6
Placebo + mFOLFOX6Placebo comparatorParticipants 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.
Receives: Drug: Placebo; Drug: Modified FOLFOX6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    PFS was defined as time from randomization until the date of radiographic disease progression based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death from any cause, whichever came first. PFS was analyzed using Kaplan-Meier methods. Participants with no progression or death, or who started new anticancer therapy before documented progression or death without documented progression, or who had ≥ 2 consecutive missing tumor assessments before documented progression or death without documented progression were censored on the date of last adequate tumor assessment. Participants with no baseline tumor assessment, were censored at the date of randomization.

    The primary efficacy analysis was pre-specified to be conducted after at least 84 PFS events were observed.

    Measured: From randomization until the primary analysis data cut-off date of 23 September 2020; median time on follow-up was 10.9 months.

Secondary outcomes (3)

  1. Overall Survival (OS)

    OS is defined as time from randomization until death from any cause. Participants who were lost to follow-up or did not have a date of death were censored at the last date that they were known to be alive. Participants with confirmed death or alive status after the data cutoff date were censored at the data cutoff date. Median OS was estimated using a Kaplan-Meier analysis.

    Measured: From randomization until the primary analysis data cut-off date of 23 September 2020; median time on follow-up was 10.9 months.

  2. Overall Response Rate (ORR)

    Tumor response assessment was performed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. ORR is defined as the percentage of participants who achieved a best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment of tumor lesions per RECIST v1.1.

    CR was defined as the disappearance of all lesions except lymph node short axis < 10 mm; PR was defined as a ≥ 30% reduction in sum of diameters in target lesions.

    Measured: Tumor assessments were performed every 8 weeks until 12 months and then every 12 weeks thereafter until disease progression or additional anticancer therapy was initiated; the median duration of follow-up time was 10.9 months.

  3. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    TEAEs are defined as adverse events (AEs) that started or worsened from the start of study drug to 28 days after permanent discontinuation of study drug.

    A serious AE is defined as any untoward medical occurrence that:

    • Resulted in death;
    • Was life-threatening;
    • Required inpatient hospitalization or prolongation of existing hospitalization;
    • Resulted in persistent or significant disability or incapacity;
    • Was a congenital anomaly or birth defect.

    The investigator assessed the causality/relationship between study treatment and each AE, and assessed the severity of each AE according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 on a scale from mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death due to the AE (Grade 5). Cornea and retina AEs were defined by Standardized Medical Dictionary for Regulatory Activities Queries (SMQs) of corneal disorders and retinal disorders (broad).

    Measured: From first dose of study drug to 28 days after last dose of study drug. Actual median (min, max) duration of treatment emergent period was 29 (4.1, 157) weeks in the bemarituzumab + mFOLFOX6 group and 28 (4.3, 133) weeks in the placebo + mFOLFOX6 group.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2018
  2. Study start14 Sep 2018
  3. Primary completion23 Sep 2020
  4. Study completion13 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03694522
Sponsor's protocol ID
FPA144-004 Phase 2
Other IDs
2017-003507-22, 20210113, 2017
Acronym
FIGHT
Status last verified
Feb 2024
First submitted
14 Sep 2018
Last updated
28 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38308771

  • 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.

    PubMed 36244398

  • 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.

    PubMed 32965540

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bemarituzumab and Modified FOLFOX6 in people with Gastric Cancer, run by Five Prime Therapeutics, Inc. at 189 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, China, Italy, Spain, South Korea and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: From randomization until the primary analysis data cut-off date of 23 September 2020; median time on follow-up was 10.9 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03694522, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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