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

PHASE2CompletedINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

September 14, 2018

Primary Completion Date

September 23, 2020

Study Completion Date

May 13, 2022

Conditions
Gastric Cancer
Interventions
BIOLOGICAL

Bemarituzumab

Administered by intravenous infusion over approximately 30 minutes

DRUG

Placebo

Administered by intravenous infusion over approximately 30 minutes

DRUG

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"

Trial Locations (189)

1122

National Institute of Oncology, Budapest

3080

Seoul National University Hospital, Seoul

4400

Josa Andras Teaching Hospital, Nyíregyháza

5000

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

6800

CH de l'Ardenne, Libramont

7624

University of Pecs, Clinic of Oncotherapy, Pécs

10060

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

10601

Westchester Institute For Treatment Of Cancer & Blood Disorders, White Plains

11794

Stony Brook Cancer Center, Stony Brook

12559

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

13620

Seoul National University Bundang Hospital, Seongnam-si

14068

Hallym University Sacred Heart Hospital, Anyang-si

14642

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

16059

Uludag Universitesi Tip Fakultesi, Bursa

16132

Ospedale Policlinico S. Martino, Genova

16499

Ajou University Hospital, Suwon

17007

Institut Catala d'Oncologia - Hospital Doctor Josep Trueta, Girona

18015

St. Luke's Physician Group - St. Luke's Cancer Care Associates, Bethlehem

20141

Istituto Europeo di Oncologia, Milan

21565

Gachon University Gil Medical Center, Incheon

25000

CHRU Jean MINJOZ, Besançon

25200

Hopital Nord France Comte - Site Le Mittan, Montbéliard

26100

Azienda Socio-Sanitaria Territoriale di Cremona, Cremona

27599

UNC- Chapel Hill, Chapel Hill

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28050

Hospital Universitario HM Sanchinarro, Madrid

28374

FirstHealth Outpatient Cancer Center, Pinehurst

29435

Medical University of South Carolina, Charleston

31008

Clinica Universidad de Navarra, Pamplona

Complejo Hospital De Navarra, Pamplona

33081

Centro di Riferimento Oncologico, Aviano

33100

Azienda Sanitaria Universitaria Integrata de Udine, Udine

34093

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi, Istanbul

35015

Chungnam National University Hospital (CNUH), Daejeon

35575

Medical Park Izmir Hastanesi, Izmir

37045

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

37909

Tennessee Cancer Specialists, Knoxville

38114

Stadtisches Klinikum Braunschweig, Braunschweig

40447

China Medical University Hospital, Taichung

41009

Hosptial Universitario Virgen Macarena, Servilla

41380

Kocaeli Universitesi Tip Fakultesi, Kocaeli

42055

CHU de Saint Etienne, Saint-Etienne

44300

Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi, Malatya

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

48109

University of Michigan Health System, Ann Arbor

48201

Karmanos Cancer Institute, Detroit

48202

Josephine Ford Cancer Center-Henry Ford Cancer Center, Detroit

49201

Dong-A University Hospital, Busan

54907

Chonbuk National University Hospital, Jeonju

55200

Ondokuz Mayis University Medicine Faculty, Atakum

60020

AOU Ospedall Riuniti Umberto, Ancona

60488

Krankenhaus Nordwest gGmbH, Institut fur Klinisch-Onkologische Forschung, Frankfurt am Main

60555

Northwestern Medicine Cancer Center Warrenville, Warrenville

60637

University of Chicago, Chicago

65080

Yuzuncuyil Universitesi Tip Fakultesi, Van

66205

University of Kansas Medical Center, Westwood

67000

Centre de Radiotherapie - Clinique Sainte Anne, Strasbourg

70121

Oschsner Clinic Foundation, New Orleans

71640

Klinikum Ludwigsburg, Ludwigsburg

76012

Arlington Cancer Center, Arlington

80131

Servizio Oncologia Medica ed Ematologia, AOU dell'Universita, Napoli

84106

Utah Cancer Specialists (Intermountain Hematology - Oncology Associates) UCS Cancer Center, South Salt Lake

85724

University of Arizona Cancer Center, Tucson

85745

The Oncology Institute of Tuscon, Tucson

90110

Faculty of Medicine, Prince of Sonkla University, Hat Yai

90404

UCLA Medical Centre - Santa Monica Hematology and Oncology, Santa Monica

90603

Innovative Clinical Research Institute (ICRI), Whittier

92637

Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik I, Oberpfalz

94904

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

95816

Sutter Medical Group, Sacramento

98101

Virginia Mason Seattle Main Clinic, Seattle

100412

Beijing Cancer Hospital, Beijing

110042

Liaoning Cancer Hospital, Shenyang

130021

The First Hospital of Jilin University, Changchun

130033

Sino Japanese Friendship Hospital of Jilin University, Changchun

200123

Shanghai East Hospital, Shanghai

200347

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

200385

SC Oncolab SRL, Oncologie, Craiova

210002

The 81st Hospital of Chinese PLA, Nanjing

210032

Fudan University Shanghai Cancer Center, Shanghai

215004

The Second Affiliated Hospital of Soochow University, Suzhou

230031

Anhui Provincial Cancer Hospital, Hefei

300060

Tianjin Medical University Cancer Institute and Hospital, Tianjin

300166

S.C. Oncocenter Oncologie Clinica S.R.L, Timișoara

310003

The First Affiliated Hospital, Zhejiang University, Hangzhou

350014

Fujian Cancer Hospital, Fuzhou

400000

Chongqing Daping Hospital, Chongqing

400015

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

400641

S.C. Medisprof S.R.L, Cluj-Napoca

410006

Hunan Cancer Hospital, Changsha

430000

Wuhan Union Hospital of China, Wuhan

442000

Shiyan Taihe Hospital, Shiyan

450008

Henan Cancer Hospital, Zhengzhou

515041

Cancer Hospital of Shantou University Medical College, Shantou

900591

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

06519

Yale Cancer Center, New Haven

06062

Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut, Plainville

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

07960

Summit Medical Group. Morristown Oncology, Morristown

Unknown

Chris O'brien Lifehouse, Camperdown

The Townsville Hospital, Douglas

Sydney Adventist Hospital, Wahroonga

AZ Sint Jan, Bruges

Chinese PLA General Hospital, Beijing

Xiangya Hospital of Central South University, Changsha

Sir Run Run Shaw Hospital, Hangzhou

Zhejiang Cancer Hospital, Hangzhou

Harbin Medical University Cancer Hopsital, Harbin

Nanton Tumor Hospital, Nantong

Ruijin Hospital Affiliated to Shanghai Jiatong University School of Medicine, Shanghai

Fourth Hospital of Hebei Medical University, Shijiazhuang

Chu Morvan - Institut de Cancerologie, Brest

Polyclinique de Gentilly, Nancy

Centre Paul Strauss, Strasbourg

Universitatsmedizin Manheim, II. Medizinische Klinik, Mannheim

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

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

Sugarterapias es Klinikai Onkologaiai Intezet B-A-Z Megyei Korhaz, Miskolc

"AO S.G. Moscati", Avellino

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

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

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

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyō City

Japan Community Health Care Organization Kyushu Hospital, Kitakyushu

The Cancer Institute Hospital of JFCR, Kōtoku

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie, Lublin

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

Hospital Senhora Da Oliveira EPE, Guimarães

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

Kyungpook National University Chilgok Hospital, Daegu

Complejo Hospitalario Universitario A Coruna, A Coruña

Hospital Universitario Fundacion Alcorcon, Alcorcón

Hospital de la Santa Creu I Sant Pau, Barcelona

Hospital General de Catalunya, Barcelona

Hospital Universitari Arnau de Vilanova, Lleida

Hospital General Universitario Gregorio Maranon, Madrid

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

Corporacio Sanitaria Parc Tauli, Sabadell

Faculty of Medicine, Chulalongkorn University, Bangkok

Chiangrai Prachanukroh Hospital, Chiang Rai

Khon Kaen Hospital, Khon Kaen

Lampang Cancer Hospital, Lampang

Cukurova University Faculty of Medicine Paediatric Nephrology, Adana

Gaziantep Universitesi Tip Fakultesi, Sahinbey Onkoloji Hastanesi, Gaziantep

Istanbul Madeniyet Universitesi Tip Fakultesi, Istanbul

Istanbul University Cerrahpasa Medical Faculty, Istanbul

Ege University Hopsital, Izmir

04000

CHC Clinique Saint-Joseph, Liège

05530

CHU UCL Namur, site Godinne, Yvoir

277-8577

National Cancer Center Hospital East, Kashiwa

761-0793

Kagawa University Hospital, Kita-gun

730-8518

Hiroshima Citizens Hospital, Hiroshima

216-8511

St. Marianna University School of Medicine Hospital, Kawasaki

951-8566

Niigata Cancer Center Hospital, Niigata

663-8501

Hyogo College of Medicine College Hospital, Nishinomiya

558-8558

Osaka General Medical Center, Osaka

569-8686

Osaka Medical College Hospital, Osaka

43-300

Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II w Bielsku-Bialej, Bielsko-Biala

36-200

Szpital Specjalistyczny w Brzozowie, Podkarpacki Osrodek Onkologiczny, Brzozów

10-228

SP ZOZ Ministerstwa Spraw Wewnetrznych z Warminsko - Mazurskim Centrum Onkologii, Olsztyn

05-400

Europejskie Centrum Zdrowia Otwock Szpital im. F. Chopina, Otwock

35-021

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

04-141

Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej, Warsaw

3814-501

Centro Hospitalar do Baixo Vouga, EPE, Aveiro

4710-243

Hospital de Braga, Braga

4099-011

Centro Hospitalar Universitario do Porto E.P.E, Porto

022328

Institutul Clinic Fundeni - Clinica Pediatrie, Bucharest

06273

Gangnam Severance Hospital, Yonsei University Health System, Seoul

02841

Korea University Anam Hospital, Seoul

03722

Yonsei University Health System, Seoul

04514

Kangbuk Samsung Hospital, Seoul

05505

Asan Medical Center, Seoul

06591

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

08308

Korea University Guro Hospital, Seoul

08003

Hospital del Mar, Barcelona

08908

Hospital Duran I Reynals - Instituto Catalan de Oncologia, Barcelona

08221

Hospital Universitario Mutua de Terrassa, Terrassa

06100

Hacettepe Universitesi Tip Fakultesi, Ankara

06200

Ankara Oncology Education and Research Hospital, Ankara

09100

Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi, Aydin

DD198Y

Ninewells Hospital and Medical School, Dundee

Sponsors
All Listed Sponsors
collaborator

Zai Lab (Shanghai) Co., Ltd.

INDUSTRY

lead

Five Prime Therapeutics, Inc.

INDUSTRY

NCT03694522 - A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer | Biotech Hunter | Biotech Hunter