153
Participants
Start Date
August 14, 2013
Primary Completion Date
June 3, 2015
Study Completion Date
January 26, 2021
5-Fluorouracil
Participants will receive bolus and infusional 5-fluorouracil on Day 1 of each 14-day cycle (as a part of mFOLFOX6 therapy), until disease progression or unacceptable toxicity. The infusion times for infusional 5-fluorouracil may be determined per local and/or institutional standards and product labeling.
Ipatasertib
Participants will receive ipatasertib, 600 milligrams (mg) orally once daily on Days 1 to 7 of each 14-day cycle until disease progression or unacceptable toxicity.
Leucovorin
Participants will receive leucovorin or equivalent substitute orally, on Day 1 of each 14-day cycle (as a part of mFOLFOX6 therapy), until disease progression or unacceptable toxicity.
Oxaliplatin
Participants will receive oxaliplatin via intravenous (IV) infusion on Day 1 of each 14-day cycle (part of mFOLFOX6 therapy). Oxaliplatin will be discontinued after completion of 8 cycles
Placebo
Participants will receive matching oral placebo capsules once daily on Days 1 to 7 of each 14-day cycle until disease progression or unacceptable toxicity.
National Taiwan Uni Hospital; Dept of Oncology, Taipei
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology, Taoyuan District
Gleneagles Medical Centre, George Town
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo., Berlin
Seoul National University Bundang Hospital, Seongnam-si
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A, Genoa
Hospital Universiti Sains Malaysia [Neurology], Kubang Kerian
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia, Madrid
Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie, Hanover
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padua
Kyungpook National University Hospital, Daegu
Hospital Clinico Universitario de Valencia, Valencia
Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica, Pisa
University Malaya Medical Centre; Clinical Oncology Unit,, Kuala Lumpur
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen, Heidelberg
University of Texas M.D. Anderson Cancer Center, Houston
Univ of Calif, Los Angeles; Hematology/Oncology, Los Angeles
Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif
National Cancer Centre; Medical Oncology, Singapore
Oncocare Cancer Centre, Singapore
Massachusetts General Hospital;Oncology, Boston
Queen Mary Hospital; Dept. of Clinical Oncology, Hong Kong
St Vincent'S Hospital; Oncology, Suwon
Gachon Medical School Gil Medical Centre; Internal Medicine, Incheon
Asan Medical Center; Medical Oncology, Seoul
Samsung Medical Center, Seoul
Seoul National University Hosp; Dept Internal Med Hem Onc, Seoul
Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept., Seoul
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona
National Cheng Kung Univ Hosp, Tainan City
Royal Marsden Hospital; Dept of Med-Onc, London
Sarah Cannon Research Institute, London
Mount Vernon Hospital; Centre For Cancer Treatment, Northwood
The Royal Marsden Hospital, Sutton
Lead Sponsor
Genentech, Inc.
INDUSTRY