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A Study of GDC-0068 in Combination With Fluoropyrimidine Plus Oxaliplatin in Patients With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

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Disease Information

Descriptive Information
Brief Title † A Study of GDC-0068 in Combination With Fluoropyrimidine Plus Oxaliplatin in Patients With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Official Title † A Randomized, Phase II, Placebo Controlled Study of GDC-0068, an Inhibitor to Akt, in Combination With Fluoropyrimidine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Brief Summary This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of GDC-0068 in combination with mFOLFOX6 chemotherapy in patients with advanced or metastatic gastric or gastroesophageal junction cancer. Patients will be randomized to receive either GDC-0068 or placebo orally daily on Days 1-7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary Outcome Measure † Progression-free survival (RECIST v1.1 criteria)
Secondary Outcome Measure † Overall survival
Condition † Gastric Cancer
Intervention † DrugGDC-0068
Study Arms / Comparison Groups GDC-0068 + mFOLFOX6 Placebo + mFOLFOX6
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 153
Start Date † August 2013
Completion Date January 2016
Primary Completion Date June 2015
Eligibility Criteria † Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Histologically documented, inoperable locally advanced or metastatic or recurrent gastric/GEJ (gastroesophageal junction) adenocarcinoma, not amenable to curative therapy - Measurable disease, according to RECIST v1.1 - Life expectancy >/= 12 weeks - Adequate hematologic and organ function Exclusion Criteria: - Previous chemotherapy for inoperable locally advanced or metastatic gastric/GEJ adenocarcinoma. Patients 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 HER2-positive gastric/GEJ adenocarcinoma. - Radiation treatment within 28 days of randomization. Patients who have received palliative radiation treatment to peripheral sites (e.g., 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, PI3K, and/or 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
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT01896531
Organization ID GO28341
Secondary IDs †† 2012-002080-10
Responsible Party Sponsor
Study Sponsor † Genentech, Inc.
Collaborators ††
Investigators † Study Director: Clinical Trials, Genentech, Inc.
Information Provided By
Verification Date May 2015
First Received Date † July 8, 2013
Last Updated Date May 28, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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