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 ( ICCC: Parexel International)0 个研究点目标入组 11 人开始时间: 2020年4月23日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.Age >= 18 years.
•2.Signed informed consent.
•3.Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
•4.Received platinum based first line chemotherapy for <= 28 weeks.
•5.Confirmed partial response (PR) maintained for >= 4 weeks or complete response (CR).
•6.Able to be randomized to study <=8 weeks after last platinum dose.
•7.ECOG performance status <= 1.
•8.Adequate hematologic, renal and hepatic function.
•9.Must be able to provide archival tumor tissue for central biomarker assessment.
•10.Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 6 months after last dosing.

•1.Unresolved acute effects of prior therapy >= Grade 2.
•2.Prior treatment with PARP inhibitor.
•3.Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy<= 14 days prior to randomization.
•4.Major surgery or significant injury <=2 weeks prior to start of study treatment.
•5.Diagnosis of myelodysplastic syndrome (MDS) or active bleeding disorder.
•6.Other diagnoses of significant malignancy
•7.Leptomeningeal disease or brain metastasis
•8.Inability to swallow capsules or disease affecting gastrointestinal function.
•9.Active infections requiring systemic treatment.
•10.Clinically significant cardiovascular disease
•11.Pregnant or nursing females

发起方

Beigene ( ICCC: Parexel International)