Phase II, Single-arm Study of Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification(SUKSE-D)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Objective reponse rate (ORR) by RECIST 1.1
研究概览
简要总结
[Study Design] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria.
[Primary Objective] To investigate the efficacy of vistusertib monotherapy in patients with relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- •Participation in another clinical study with an investigational product during the last 21 days.
- •Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. Prior use of an investigational monoclonal antibody therapy within 3 months.
- •Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment.
- •Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix 1)
- •Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period
- •Any haemopoietic growth factors within 14 days prior to receiving study treatment.
- •Pre-treatment with other PI3K, AKT, dual PI3K/mTRO and mTOR inhibitors
- •Spinal cord compression and/or brain metastases unless asymptomatic or treated and stable off steroids for at least 4 weeks prior to start of study treatment.
研究组 & 干预措施
vistusertib (AZD2014)
vistusertib (AZD2014), 50 mg,BID, per os, every 12 hours
干预措施: vistusertib (AZD2014) (Drug)
结局指标
主要结局
Objective reponse rate (ORR) by RECIST 1.1
时间窗: Up to 20 months
Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1
次要结局
- Number of participants with Adverse Events as Assessed by CTCAE v4.03(Up to 20 months)
- Duration of response(Up to 20 months)
- Disease control rate(at 12 weeks)
- Overall survival (OS)(Up to 20 months)
- Progression-free survival (PFS)(Up to 20 months)
研究者
Keunchil Park
Principal Investigator
Samsung Medical Center