EUCTR2012-002080-10-IT进行中（未招募）1 期
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.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 153
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •- 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.
研究者
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