Spots Global Cancer Trial Database for A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
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Trial Identification
Brief Title: A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
Official Title: An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
Study ID: NCT01461057
Conditions
Study Description
Brief Summary: This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Masaryk Memorial Cancer Institute; Oncological Clinic, Brno, , Czechia
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology, Hradec Kralove, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, , Czechia
Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni, Praha 5, , Czechia
University Hospital Na Bulovce; Institut of Radiation Oncology, Praha 8, , Czechia
Hopital Morvan, Brest, , France
CRLCC Val dAurelle Paul Lam, Montpellier cedex 5, , France
Hopital Robert Debre; DERMATOLOGIE, Reims, , France
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo., Berlin, , Germany
Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie, Braunschweig, , Germany
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie, Frankfurt, , Germany
Klinikum Mannheim III. Medizinische Klinik, Mannheim, , Germany
Campus Universitario S.Venuta; Centro Oncologico T.Campanella, Catanzaro, Calabria, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2, Milano, Lombardia, Italy
A.O. Universitaria Pisana; Oncologia, Pisa, Toscana, Italy
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology, Seoul, , Korea, Republic of
Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology, Seoul, , Korea, Republic of
Asan Medical Center; Medical Oncology, Seoul, , Korea, Republic of
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde, Maastricht, , Netherlands
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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