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
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, MontbĂŠliard, , France
Polyclinique de Gentilly, Nancy, , France
CHU de Saint Etienne, Saint-Ătienne, , 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, NyĂregyhĂĄza, , 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, BunkyĹ-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, BrzozĂłw, , 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, RzeszĂłw, , 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, GuimarĂŁes, , 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, ConstanĹŁa, , 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 CoruĂąa, , 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
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