Phase 1 Multicenter, Dose-Escalation Clinical Study of the Safety and Tolerability of Intravenously Administered SNS-032 Injection, a Novel Cyclin-Dependent Kinase Inhibitor, Administered to Patients With Advanced B-Lymphoid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- To assess the safety and tolerability of SNS-032
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of escalating doses of SNS-032, given in 3 weekly administrations per cycle and to identify a recommended Phase 2 dose.
详细描述
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body) and identifying potential biomarkers.
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
- •Cytologically or histologically confirmed chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), or multiple myeloma (MM).
- •Evidence of relapsed disease
- •Measurable disease
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
排除标准
- •Prior treatment with SNS-032 injection (previously known as BMS-387032)
- •Pregnant or breastfeeding
- •Unwilling to use an approved, effective means of contraception according to the study site's standards
- •Use of therapeutic anticoagulation agents
- •Prior allogeneic bone marrow transplantation
- •Prior chemotherapy, monoclonal antibodies, investigational agents, or radiation therapy within 21 days before the first dose; nitrosoureas and mitomycin are not permitted for at least 42 days before the first dose.
- •Prior pelvic radiation therapy or radiation to > 25% of bone marrow reserve
- •Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
- •Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if the patient meets all study criteria.
研究组 & 干预措施
Dose-escalation of SNS-032 injection
Patients escalated to MTD starting in Cohort 1 of 15 mg/m2 of SNS-032 injection, with 1.5-fold increase each cohort and a maximum loading dose increase of 10 mg/m2. Each dose cohort will have a minimum of 3 patients each with advanced CLL or MM. Dose escalation continues in the absence of Cycle 1 DLT criteria until an MTD is achieved for each disease type to a maximum of 7 cohorts at a high dose of 70 mg/m2. Stage 2 tests at MTD in larger group.
干预措施: SNS-032 Injection (Drug)
结局指标
主要结局
To assess the safety and tolerability of SNS-032
时间窗: 1 year
次要结局
- To characterize the pharmacokinetic profile of SNS-032(1 year)
- Identify a recommended Phase 2 dose and schedule of administration(1 year)