EUCTR2017-003493-13-BE进行中（未招募）1 期
A Phase 3, Double-blind, Randomized Study of BGB-290 versus Placebo as Maintenance Therapy in Patients with Inoperable Locally Advanced or Metastatic Gastric Cancer that Responded to Platinum-based First-line Chemotherapy
BeiGene Ltd.0 个研究点目标入组 540 人开始时间: 2018年3月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 540
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
- •Patients must meet all of the following criteria to be eligible for the study:
- •1) Age 18 years
- •2) Histologically proven adenocarcinoma of the stomach or gastroesophageal junction, inoperable locally advanced or with metastatic disease
- •a) Patients with gastric cancer overexpressing HER2 are not allowed.
- •b) Irradiation as part of prior first-line treatment is not allowed.
- •3) Availability of archival tumor tissue for central laboratory determination of HRD status for randomization and exploratory biomarker analyses
- •4) Confirmed PR that is maintained for >=4 weeks or CR as determined by the investigator per RECIST Version 1.1
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 340
排除标准
- •1) Unresolved acute effects of prior therapy of Grade =2
- •2) Prior treatment with a PARP inhibitor
- •3) Chemotherapy, biologic therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or anticancer herbal remedies =14 days prior to randomization
- •4) Diagnosis of MDS
- •5) Leptomeningeal disease or brain metastasis
- •6) Previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease causing malabsorption syndrome
- •7) Active bleeding disorder
研究者
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已完成
2 期
BGB-290-303Inoperable Locally Advanced or Metastatic GastricCancerJPRN-jRCT2080225173Beigene ( ICCC: Parexel International)11