Status:
COMPLETED
A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Lead Sponsor:
Genentech, Inc.
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 \[mFOLF...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 14 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2021
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT01896531
Start Date
August 14 2013
End Date
January 26 2021
Last Update
March 2 2022
Active Locations (34)
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1
Univ of Calif, Los Angeles; Hematology/Oncology
Los Angeles, California, United States, 90095
2
Massachusetts General Hospital;Oncology
Boston, Massachusetts, United States, 02114
3
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
4
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, France, 94805