A Phase 2, 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 128 人开始时间: 2017年12月1日最近更新: 2020年12月7日

适应症

试验速览

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•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 48
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•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

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