Clinical trial NCT03694522: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Five Prime Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Zai Lab (Shanghai) Co., Ltd.
First posted: 2018-10-03
Enrollment: 155
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 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.

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.

Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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:
measure: Overall Survival (OS)
timeFrame: From randomization until the primary analysis data cut-off date of 23 September 2020; median time on follow-up was 10.9 months.
measure: Overall Response Rate (ORR)
timeFrame: 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.
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: 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.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Tucson
country: United States
facility: The Oncology Institute of Tuscon
state: Arizona
city: Greenbrae
country: United States
facility: Marin Cancer Care, Inc-California Cancer Care A Medical Group, Inc
state: California
city: Sacramento
country: United States
facility: Sutter Medical Group
state: California
city: Santa Monica
country: United States
facility: UCLA Medical Centre - Santa Monica Hematology and Oncology
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute (ICRI)
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Plainville
country: United States
facility: Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut
state: Connecticut
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Warrenville
country: United States
facility: Northwestern Medicine Cancer Center Warrenville
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Oschsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Josephine Ford Cancer Center-Henry Ford Cancer Center
state: Michigan
city: Morristown
country: United States
facility: Summit Medical Group. Morristown Oncology
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
city: White Plains
country: United States
facility: Westchester Institute For Treatment Of Cancer & Blood Disorders
state: New York
city: Chapel Hill
country: United States
facility: UNC- Chapel Hill
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Bethlehem
country: United States
facility: St. Luke's Physician Group - St. Luke's Cancer Care Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: S. Salt Lake
country: United States
facility: Utah Cancer Specialists (Intermountain Hematology - Oncology Associates) UCS Cancer Center
state: Utah
city: Seattle
country: United States
facility: Virginia Mason Seattle Main Clinic
state: Washington
city: Camperdown
country: Australia
facility: Chris O'brien Lifehouse
city: Douglas
country: Australia
facility: The Townsville Hospital
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Libramont
country: Belgium
facility: CH de l'Ardenne
city: Liege
country: Belgium
facility: CHC Clinique Saint-Joseph
city: Yvoir
country: Belgium
facility: CHU UCL Namur, site Godinne
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Shiyan
country: China
facility: Shiyan Taihe Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital of China
state: Hubei
city: Nanjing
country: China
facility: The 81st Hospital of Chinese PLA
state: Jiangsu
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changchun
country: China
facility: Sino Japanese Friendship Hospital of Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Chongqing
country: China
facility: Chongqing Daping Hospital
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hopsital
city: Nantong
country: China
facility: Nanton Tumor Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiatong University School of Medicine
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Besançon
country: France
facility: CHRU Jean MINJOZ
city: Brest
country: France
facility: Chu Morvan - Institut de Cancerologie
city: Montbéliard
country: France
facility: Hopital Nord France Comte - Site Le Mittan
city: Nancy
country: France
facility: Polyclinique de Gentilly
city: Saint-Étienne
country: France
facility: CHU de Saint Etienne
city: Strasbourg
country: France
facility: Centre de Radiotherapie - Clinique Sainte Anne
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Berlin
country: Germany
facility: Klinik fur Innere Medizin, Shwerpunkt Gastroenterologie, Hamatologie, Onkologie, Nephrologie
city: Braunschweig
country: Germany
facility: Stadtisches Klinikum Braunschweig
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nordwest gGmbH, Institut fur Klinisch-Onkologische Forschung
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
city: Mannheim
country: Germany
facility: Universitatsmedizin Manheim, II. Medizinische Klinik
city: Mutlangen
country: Germany
facility: Klinikum Ostalb, Stauferklinikum Schwabisch Gmund, Zentrum fur Innere Medizin
city: Oberpfalz
country: Germany
facility: Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik I
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Budapest
country: Hungary
facility: Del-Pesti Centrumkorhaz - Orszangos Hematologiai es Infektologiai Intezet, Onkologiai Osztaly
city: Miskolc
country: Hungary
facility: Sugarterapias es Klinikai Onkologaiai Intezet B-A-Z Megyei Korhaz
city: Nyíregyháza
country: Hungary
facility: Josa Andras Teaching Hospital
city: Pecs
country: Hungary
facility: University of Pecs, Clinic of Oncotherapy
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet
city: Ancona
country: Italy
facility: AOU Ospedall Riuniti Umberto
city: Avellino
country: Italy
facility: AO "S.G. Moscati"
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
city: Candiolo
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico - IRCCS di Candiolo
city: Cremona
country: Italy
facility: Azienda Socio-Sanitaria Territoriale di Cremona
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Caregg - I S.O.D. Oncologia Medica
city: Genova
country: Italy
facility: Ospedale Policlinico S. Martino
city: Legnago
country: Italy
facility: Ospedale Generale Mater Salutis" - Azienda ULSS n. 21 di Legnago
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: Servizio Oncologia Medica ed Ematologia, AOU dell'Universita
city: Pavia
country: Italy
facility: Fondazione Irccs Policlinico San Matteo
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico di Roma
city: San Giovanni Rotondo
country: Italy
facility: Fondazione IRCSS Casa Sollievo Della Sofferenza
city: Sondrio
country: Italy
facility: ASST della Valtellina e dell'Alto Lario - PO di Sondrio
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata de Udine
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Bunkyō-Ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Citizens Hospital
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital
city: Kitakyushu
country: Japan
facility: Japan Community Health Care Organization Kyushu Hospital
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine College Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Osaka
country: Japan
facility: Osaka Medical College Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
state: Gangnam
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Namdong-gu
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: North Gyeongsang
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital (CNUH)
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Bielsko-Biala
country: Poland
facility: Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II w Bielsku-Bialej
city: Brzozów
country: Poland
facility: Szpital Specjalistyczny w Brzozowie, Podkarpacki Osrodek Onkologiczny
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
city: Olsztyn
country: Poland
facility: SP ZOZ Ministerstwa Spraw Wewnetrznych z Warminsko - Mazurskim Centrum Onkologii
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock Szpital im. F. Chopina
city: Rzeszów
country: Poland
facility: Lekarz Beata Madej Mruk I Partner. Spolka Partnerska Oddzial nr 1 w Rzesowie
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Onkologi I Radioterapii
city: Aveiro
country: Portugal
facility: Centro Hospitalar do Baixo Vouga, EPE
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guimarães
country: Portugal
facility: Hospital Senhora Da Oliveira EPE
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto E.P.E
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E
city: Santa Maria Da Feira
country: Portugal
facility: Centro Hospitalar de Entre o Douro e Vouga EPE
city: Senhora Da Hora
country: Portugal
facility: Unidade Local de Saude de Matosinhos EPE
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni - Clinica Pediatrie
city: Cluj Napoca
country: Romania
facility: S.C. Medisprof S.R.L
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic, Prof. Dr. I. Chiricuta Cluj-Napoca
city: Constanţa
country: Romania
facility: Spitalul Clinic Judetean de Urgenta ,,Sf. Apostol Andrei" Constanta, Clinica Oncologie Medicala
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala
city: Craiova
country: Romania
facility: SC Oncolab SRL, Oncologie
city: Timisoara
country: Romania
facility: S.C. Oncocenter Oncologie Clinica S.R.L
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Duran I Reynals - Instituto Catalan de Oncologia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital General de Catalunya
city: Girona
country: Spain
facility: Institut Catala d'Oncologia - Hospital Doctor Josep Trueta
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Pamplona
country: Spain
facility: Complejo Hospital De Navarra
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Servilla
country: Spain
facility: Hosptial Universitario Virgen Macarena
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua de Terrassa
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Bankok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
city: Chiang Rai
country: Thailand
facility: Chiangrai Prachanukroh Hospital
city: Hat Yai
country: Thailand
facility: Faculty of Medicine, Prince of Sonkla University
city: Khon Kaen
country: Thailand
facility: Khon Kaen Hospital
city: Lampang
country: Thailand
facility: Lampang Cancer Hospital
city: Adana
country: Turkey
facility: Cukurova University Faculty of Medicine Paediatric Nephrology
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Ankara
country: Turkey
facility: Ankara Oncology Education and Research Hospital
city: Atakum
country: Turkey
facility: Ondokuz Mayis University Medicine Faculty
city: Aydin
country: Turkey
facility: Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi
city: Bursa
country: Turkey
facility: Uludag Universitesi Tip Fakultesi
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Tip Fakultesi, Sahinbey Onkoloji Hastanesi
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Madeniyet Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Izmir
country: Turkey
facility: Medical Park Izmir Hastanesi
city: Izmir
country: Turkey
facility: Ege University Hopsital
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi
city: Malatya
country: Turkey
facility: Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi
city: Van
country: Turkey
facility: Yuzuncuyil Universitesi Tip Fakultesi
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.