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Spots Global Cancer Trial Database for A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer

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Trial Identification

Brief Title: 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 ID: NCT03694522

Conditions

Gastric Cancer

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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, S. 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, Brugge, , Belgium

CH de l'Ardenne, Libramont, , Belgium

CHC Clinique Saint-Joseph, Liege, , 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-Étienne, , 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, Pecs, , 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, Firenze, , 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, Japan

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyō-Ku, , 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, Koto-Ku, , 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

Gangnam Severance Hospital, Yonsei University Health System, Seoul, Gangnam, Korea, Republic of

Hallym University Sacred Heart Hospital, Anyang, Gyeonggi-do, Korea, Republic of

Seoul National University Bundang Hospital, Seongnam, Gyeonggi, Korea, Republic of

Ajou University Hospital, Suwon, Gyeonggi, Korea, Republic of

Chonbuk National University Hospital, Jeonju, Jeollabuk-do, Korea, Republic of

Gachon University Gil Medical Center, Incheon, Namdong-gu, Korea, Republic of

Kyungpook National University Chilgok Hospital, Daegu, North Gyeongsang, Korea, Republic of

Dong-A University Hospital, Busan, , Korea, Republic of

Chungnam National University Hospital (CNUH), Daejeon, , Korea, Republic of

Korea University Anam Hospital, Seoul, , Korea, Republic of

Yonsei University Health System, Seoul, , Korea, Republic of

Kangbuk Samsung Hospital, Seoul, , Korea, Republic of

Asan Medical Center, Seoul, , Korea, Republic of

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

Korea University Guro Hospital, Seoul, , Korea, Republic of

Seoul National University Hospital, Seoul, , Korea, Republic of

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, Warszawa, , Poland

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

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

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

Spitalul Clinic Judetean de Urgenta ,,Sf. Apostol Andrei" Constanta, Clinica Oncologie Medicala, Constanţa, , 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, Timisoara, , Romania

Complejo Hospitalario Universitario A Coruna, A Coruña, , Spain

Hospital Universitario Fundacion Alcorcon, Alcorcon, , 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, Bankok, , 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

Hacettepe Universitesi Tip Fakultesi, Ankara, , Turkey

Ankara Oncology Education and Research Hospital, Ankara, , Turkey

Ondokuz Mayis University Medicine Faculty, Atakum, , Turkey

Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi, Aydin, , Turkey

Uludag Universitesi Tip Fakultesi, Bursa, , Turkey

Gaziantep Universitesi Tip Fakultesi, Sahinbey Onkoloji Hastanesi, Gaziantep, , Turkey

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi, Istanbul, , Turkey

Istanbul Madeniyet Universitesi Tip Fakultesi, Istanbul, , Turkey

Istanbul University Cerrahpasa Medical Faculty, Istanbul, , Turkey

Medical Park Izmir Hastanesi, Izmir, , Turkey

Ege University Hopsital, Izmir, , Turkey

Kocaeli Universitesi Tip Fakultesi, Kocaeli, , Turkey

Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi, Malatya, , Turkey

Yuzuncuyil Universitesi Tip Fakultesi, Van, , Turkey

Ninewells Hospital and Medical School, Dundee, , United Kingdom

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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