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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 65
- 主要终点
- Progression Free Survival (PFS) by Investigator Assessment
研究概览
简要总结
This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.
详细描述
This is a double-blind, placebo controlled, randomized multicenter global phase 2 study comparing the efficacy and safety of single agent poly (ADP-ribose) polymerase (PARP) inhibitor BGB-290 to placebo as maintenance therapy in participants with advanced gastric cancer who have responded to first line platinum based chemotherapy. Participants are randomized 1:1 to BGB-290 (Arm A) or placebo (Arm B). Randomization will be stratified by geography, biomarker status, and ECOG performance status.
Participants will undergo tumor assessments at screening and then every 8 weeks, or as clinically indicated. Administration of BGB-290 or placebo will continue until disease progression, unacceptable toxicity, death, or another discontinuation criterion is met.
After end of treatment, long-term follow-up assessments include tumor imaging every 8 weeks for those participants without disease progression, survival status, and new anticancer therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Signed informed consent.
- •Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
- •Received platinum based first line chemotherapy for ≤ 28 weeks.
- •Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).
- •Able to be randomized to study ≤ 8 weeks after last platinum dose.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Adequate hematologic, renal and hepatic function.
- •Must be able to provide archival tumor tissue for central biomarker assessment.
- •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.
排除标准
- •Unresolved acute effects of prior therapy ≥ Grade
- •Prior treatment with PARP inhibitor.
- •Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days prior to randomization.
- •Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.
- •Diagnosis of myelodysplastic syndrome (MDS)
- •Other diagnoses of significant malignancy
- •Leptomeningeal disease or brain metastasis
- •Inability to swallow capsules or disease affecting gastrointestinal function.
- •Active infections requiring systemic treatment.
- •Clinically significant cardiovascular disease
- •Pregnant or nursing females.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Pamiparib
Participants received pamiparib orally.
干预措施: Pamiparib (Drug)
Placebo
Participants received placebo orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival (PFS) by Investigator Assessment
时间窗: Approximately 23 months
PFS is defined as the time from randomization to progressive disease (PD) per Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.
次要结局
- Duration of Response (DOR)(Approximately 23 months)
- Time To Response(Approximately 23 months)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months))
- Overall Survival (OS)(Approximately 23 months)
- Time To Second Subsequent Treatment (TSST)(Approximately 23 months)
- Objective Response Rate (ORR)(Approximately 23 months)