A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer (JACOB)
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed metastatic adenocarcinoma of the stomach or GEJ
- Measurable or evaluable non-measurable disease as assessed by the investigator according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy greater than equal to (>/=) 3 months
Exclusion Criteria:
- Previous cytotoxic chemotherapy for advanced (metastatic) disease
- Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma
- Previous treatment with any HER2-directed therapy, at any time, for any duration
- Previous exposure to any investigational treatment within 30 days before the first dose of study treatment
- Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks if given as palliation to bone metastases, if recovered from all toxicities)
- History or evidence of brain metastases
- Clinically significant active gastrointestinal (GI) bleeding (Grade >/=2 according to National Cancer Institute [NIC]-Common Terminology Criteria for Adverse Events Version 4.0 [CTCAEv.4.0])
- Residual toxicity resulting from previous therapy (for example, hematologic, cardiovascular, or neurologic toxicity that is Grade >/=2). Alopecia is permitted
- Other malignancy (in addition to gastric cancer [GC]) within 5 years before enrollment, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that has been previously treated with curative intent
- Inadequate hematologic, renal or liver function
- Pregnant or lactating women
- History of congestive heart failure of any New York Heart Association (NYHA) criteria
- Angina pectoris requiring treatment
- Myocardial infarction within the past 6 months before the first dose of study drug
- Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia
- History or evidence of poorly controlled hypertension
- Baseline left ventricular ejection fraction (LVEF) value less than (<) 55 percent (%)
- Any significant uncontrolled intercurrent systemic illness
- Positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
Sites / Locations
- Florida Cancer Specialists - SCRI; Pharmacy
- University Of Chicago Medical Center; Section Of Hematology/Oncology
- Indiana University Health; Goshen Center for Cancer Care
- Comprehensive Cancer Centers of Nevada - Eastern Avenue
- New York Oncology Hematology, P.C.
- Queens Medical Associates
- Weill Medical College of Cornell University; Division of Hematology & Medical Oncology
- Oncology Hematology Care
- Medical University of South Carolina; Hollings Cancer Center
- Tennessee Oncology PLLC - Nashville (20th Ave)
- Royal Brisbane Womens Hosp; Division of Oncology
- Monash Medical Centre; Oncology
- Austin Health; Cancer Clinical Trial Centre
- Sir Charles Gairdner Hospital; Medical Oncology
- Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
- Krankenhaus St. Vinzenz Der Barmherzigen Schwestern Zams; Abt. Für Innere Medizin
- Cliniques Universitaires St-Luc
- Clinicas Oncologicas Integradas - COI
- Hospital Nossa Senhora da Conceicao
- Hospital das Clinicas - UFRGS
- Centro de Pesquisas Oncologicas - CEPON
- Hospital Sirio Libanes; Centro de Oncologia
- Clinica de Oncologia Medica
- Hospital A. C. Camargo; Oncologia
- Universidade Federal de Sao Paulo - UNIFESP*X
- Complex Oncological Center - Plovdiv, EOOD
- MHAT Serdika
- SHATOD Dr. Marko Antonov Markov-Varna, EOOD; Department of Medicinall Onchotherapy and Palliative
- Hamilton Health Sciences - Juravinski Cancer Centre
- London Regional Cancer Centre
- Health Sciences North
- Toronto East General Hospital; Haematology/Oncology
- Sunnybrook Health Science Centre
- Mount Sinai Hospital; Oncology
- McGill University; Glen Site; Oncology
- Cancer Hospital Chinese Academy of Medical Sciences.
- The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
- Beijing Cancer Hospital
- the First Hospital of Jilin University
- Jilin Cancer Hospital
- Changzhou First People's Hospital
- Third Affiliated Hospital of Third Military Medical University
- Fuzhou General Hospital, PLA Nanjing Military Area Command
- Sun Yet-sen University Cancer Center
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
- Harbin Medical University Cancer Hospital
- The 1st Affiliated Hospital of Nanchang Unversity
- The 81st Hospital of P.L.A.
- Affiliated Hospital of Nantong University
- Zhongshan Hospital Fudan University
- Fudan University Shanghai Cancer Center
- General Hospital of Shenyang Military Command of PLA
- Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
- The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
- The Affiliated Hospital of Xuzhou Medical College
- Henan Cancer Hospital
- The First Affiliated Hospital of Zhengzhou University
- Clinical Hospital Centre Zagreb
- Clinical Hospital Sisters of Mercy
- Hospital Oncologia; Oncology
- Docrates Cance Center
- Turku Uni Central Hospital; Oncology Clinics
- Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
- Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
- Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
- Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie
- Universitätsklinikum Hamburg-Eppendorf; Hubertus Wald Tumorzentrum
- Universitaetsklinikum Leipzig, Universitaeres Krebszentrum Leipzig (UCCL)
- Klinikum Ludwigsburg; Studiensekretariat
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz; II. Medizinische Klinik
- Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum
- Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie
- Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I
- Medical Solution; Hematology
- Semmelweis Egyetem Onkologiai Központ
- Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
- Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
- Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez
- Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
- Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
- Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
- AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
- Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
- Policlinico Universitario Agostino Gemelli
- Asst Papa Giovanni XXIII; Oncologia Medica
- Irccs Ospedale San Raffaele
- Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
- Ospedali Riuniti Di Ancona; Oncology
- Ospedale Casa Sollievo Della Sofferenza IRCCS
- Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
- Ospedale Misericordia E Dolce; Oncologia Medica
- Aichi Cancer Center Hospital; Clinical Oncology
- Nagoya university Hospital; Gastroenterological Surgery 2
- National Cancer Center Hospital East; Gastroenterology
- National Hospital Organization Shikoku Cancer Center; Gastroenterology
- Kyushu University Hospital; Surgery and Science
- Gifu University Hospital; Digestive Surgery
- Hiroshima City Hiroshima Citizens Hospital; Surgery
- Kobe city Medical center General Hospital; Medical Oncology
- St.Marianna University School of Medicine hospital; Medical Oncology
- Kanagawa Cancer Center; Gastrointestinal Surgery
- Osaka International Cancer Institute;; Medical oncology and Gastrointestinal oncology
- Osaka General Medical Center; Gastroenterological Surgery
- Saitama Cancer Center; Gastroenterology
- National Cancer Center Hospital; Gastrointestinal Oncology
- Toyama University Hospital;Gastroenterology and Hematology
- Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department
- Kyungpook National University Medical Center
- Samsung Medical Center
- Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
- Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
- Asan Medical Center; Medical Oncology
- Seoul St Mary's Hospital
- Hospital Universiti Sains Malaysia [Neurology]
- Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
- University Malaya Medical Centre; Clinical Oncology Unit,
- Hospital Wanita dan Kanak-Kanak Sabah
- Hospital Angeles Metropolitano; Room 220
- Inst. Nacional de Cancerologia; Investigacion Clinica
- Oaxaca Site Management Organization
- Academisch Medisch Centrum Universiteit Amsterdam
- Clinical Hospital; Oncology Department
- University Clinic for Radiotherapy and Oncology
- Medical Research Centre
- Centro Medico Monte Carmelo
- Hospital Sabogal; Oncology
- Hosp Nacion Edgardo Rebagliati; Oncologia Medica
- Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
- Clinica San Borja
- Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej
- Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
- Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
- Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
- SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
- NZOZ Centrum Medyczne HCP Sp. z o.o.
- Wojewódzki Szpital Specjalistyczny Nr 3
- Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej
- Cardiomed Medical Center
- Oncology Center Sf. Nectarie
- Euroclinic Center of Oncology SRL
- Clinical Oncology Dispensary of Ministry of Health of Tatarstan
- Clinical Oncology Dispensary; Chemotherapy
- SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF
- SBI of Healthcare Samara Regional Clinical Oncology Dispensary
- Hospital General Universitario de Elche; Servicio de Oncologia
- Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
- Hospital Universitario Reina Sofia; Servicio de Oncologia
- Hospital del Mar; Servicio de Oncologia
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
- Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
- Hospital Duran i Reynals; Oncologia
- Hospital Ramon y Cajal; Servicio de Oncologia
- Hospital Universitario 12 de Octubre; Servicio de Oncologia
- CHUV; Departement d'Oncologie
- Luzerner Kantonsspital; Medizinische Onkologie
- Taichung Veterans General Hospital; Dept of Surgery
- National Cheng Kung University Hospital; Oncology
- Taipei Veterans General Hospital
- National Taiwan Uni Hospital; Dept of Oncology
- Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
- Rajavithi Hospital; Division of Medical Oncology
- Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
- Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
- Khonkaen Hospital
- Songklanagarind Hospital; Department of Oncology
- Ankara Uni School of Medicine; Medical Oncology
- Akdeniz University Medical Faculty; Medical Oncology Department
- Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
- Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
- Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
- TC Necmettin Erbakan University Meram Medical Faculty Hospital
- Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Pertuzumab + Trastuzumab + Chemotherapy
Placebo + Trastuzumab + Chemotherapy
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants will continue to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Participants will receive placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants will continue to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.