Spots Global Cancer Trial Database for A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
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Trial Identification
Brief Title: A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Official Title: A Randomized, Phase II, Placebo-controlled Study of Ipatasertib (GDC-0068), an Inhibitor to Akt, in Combination With Fluoropyrimidine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Study ID: NCT01896531
Conditions
Study Description
Brief Summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 \[mFOLFOX6\]) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either ipatasertib or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Univ of Calif, Los Angeles; Hematology/Oncology, Los Angeles, California, United States
Massachusetts General Hospital;Oncology, Boston, Massachusetts, United States
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif, , France
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo., Berlin, , Germany
Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie, Hannover, , Germany
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen, Heidelberg, , Germany
Queen Mary Hospital; Dept. of Clinical Oncology, Hong Kong, , Hong Kong
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A, Genova, Liguria, Italy
Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica, Pisa, Toscana, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padova, Veneto, Italy
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Gachon Medical School Gil Medical Centre; Internal Medicine, Incheon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Asan Medical Center; Medical Oncology, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hosp; Dept Internal Med Hem Onc, Seoul, , Korea, Republic of
Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept., Seoul, , Korea, Republic of
St Vincent'S Hospital; Oncology, Suwon, , Korea, Republic of
Hospital Universiti Sains Malaysia [Neurology], Kubang Kerian, Kelantan, Malaysia
University Malaya Medical Centre; Clinical Oncology Unit,, Kuala Lumpur, , Malaysia
Gleneagles Medical Centre, Penang, , Malaysia
National Cancer Centre; Medical Oncology, Singapore, , Singapore
Oncocare Cancer Centre, Singapore, , Singapore
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
National Cheng Kung Univ Hosp, Tainan, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology, Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology, Taoyuan, , Taiwan
Royal Marsden Hospital; Dept of Med-Onc, London, , United Kingdom
Sarah Cannon Research Institute, London, , United Kingdom
Mount Vernon Hospital; Centre For Cancer Treatment, Northwood, , United Kingdom
The Royal Marsden Hospital, Sutton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR
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