A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Completed · Phase 2 · Has a placebo group
Conditions studied: Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT01896531
- Run by
- Genentech, Inc.
- People needed
- 153
- Starts
- 2013-08-14
- Expected to finish
- 2021-01-26
- Last updated by the study team
- 2022-03-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically documented, inoperable locally advanced or metastatic or recurrent gastric/GEJ adenocarcinoma, not amenable to curative therapy
- Measurable disease, according to RECIST v1.1
- Life expectancy greater than or equal to (>/=) 12 weeks
- Adequate hematologic and organ function
You may not qualify if…
- Previous chemotherapy for inoperable locally advanced or metastatic gastric/GEJ adenocarcinoma. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced gastric/GEJ adenocarcinoma, provided all treatments were completed >/= 6 months prior to randomization.
- Known human epidermal growth factor receptor 2 (HER2)-positive gastric/GEJ adenocarcinoma
- Radiation treatment within 28 days of randomization. Participants who have received palliative radiation treatment to peripheral sites (eg, bone metastases) within 28 days of randomization may be enrolled in the study if they have recovered from all acute, reversible effects and with notification of the Medical Monitor.
- Previous therapy for gastric/GEJ adenocarcinoma with Akt, phosphatidylinositol 3-kinase (PI3K), and/or mammalian target of rapamycin (mTOR) inhibitors
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
Where it is running
- 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 — Hanover, 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 — Genoa, Liguria, Italy
- Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica — Pisa, Tuscany, Italy
- IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda — Padova, Veneto, Italy
- Hospital Universiti Sains Malaysia [Neurology] — Kubang Kerian, Kelantan, Malaysia
- Gleneagles Medical Centre — George Town, Malaysia
- University Malaya Medical Centre; Clinical Oncology Unit, — Kuala Lumpur, Malaysia
- National Cancer Centre; Medical Oncology — Singapore, Singapore
- Oncocare Cancer Centre — Singapore, Singapore
- Kyungpook National University Hospital — Daegu, South Korea
- Gachon Medical School Gil Medical Centre; Internal Medicine — Incheon, South Korea
- Seoul National University Bundang Hospital — Seongnam-si, South Korea
- Asan Medical Center; Medical Oncology — Seoul, South Korea
- Samsung Medical Center — Seoul, South Korea
- Seoul National University Hosp; Dept Internal Med Hem Onc — Seoul, South Korea
- Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept. — Seoul, South Korea
- St Vincent'S Hospital; Oncology — Suwon, South Korea
- Hospital Univ Vall d'Hebron; Servicio de Oncologia — Barcelona, Spain
Full record on ClinicalTrials.gov
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