A Randomized Phase II Study of GDC-0068, an Inhibitor to Akt, in Combination with Fluoropyrimidine Plus Oxaliplatin Chemotherapy (mFOLFOX6) in Patients with Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer.
- Conditions
- Inoperable locally advanced or metastatic or recurrent gastric or gastroesophageal adenocarcinoma.MedDRA version: 19.0Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 100000004864MedDRA version: 19.0Level: LLTClassification code 10071114Term: Metastatic gastric adenocarcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002080-10-DE
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 153
- Signed Informed Consent Form (ICF);
- Age =18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Histologically documented, inoperable locally advanced, metastatic, or recurrent gastric or gastroesophageal junction adenocarcinoma, not amenable to curative therapy;
- Availability at the site of a representative tumor specimen that enabled the diagnosis of gastric or gastroesophageal junction adenocarcinoma.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
- Previous chemotherapy for inoperable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;
- Known HER2-positive gastric or gastroesophageal junction adenocarcinoma;
- Radiation treatment within 28 days of randomization;
- Previous therapy for gastric or gastroesophageal junction 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To estimate the efficacy of GDC-0068 combined with mFOLFOX6 chemotherapy compared with placebo combined with mFOLFOX6 chemotherapy in patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, as measured by progression-free survival.;Secondary Objective: To estimate the clinical activity, as measured by overall survival, objective response rate, and duration of objective tumor response of GDC-0068 combined with mFOLFOX6 chemotherapy compared with placebo combined with mFOLFOX6 chemotherapy.;Primary end point(s): Progression-free survival;Timepoint(s) of evaluation of this end point: 24 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall survival, confirmed tumor response rate by RECIST criteria version 1.1, and duration of confirmed tumor response by RECIST version 1.1;Timepoint(s) of evaluation of this end point: 24 months