An Open Label, Dose-Escalation Study to Evaluate Safety, Tolerability, Maximum Tolerated Dose (MTD), Efficacy, and Pharmacokinetics (PKs) of CPI-613 Given Twice Weekly for Three Consecutive Weeks in Patients With Advanced Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.
研究概览
简要总结
Chemotherapy resistance is a major cause of death in patients with advanced hematologic malignancies. The proposed novel mechanism of action, non-cross resistance with chemotherapeutic agents currently used in the clinic, and lack of CPI-613-related myelosuppression preclinically and clinically to date make CPI-613 a suitable candidate for phase I clinical trial in these patients. The current trial is one of several clinical trials of CPI-613. Other clinical trials that are conducted in patients with solid tumors have already been initiated.
The primary objective of this study is to determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.
The secondary objective is to determine the PKs of CPI-613 following IV administration and to observe the anti-tumor effects of CPI-613, if any occur.
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
- •histologically or cytologically documented relapsed and/or refractory hematologic malignancy
- •Karnofsky Performance Status (KPS) of >70%.
- •Must be ≥18 years of age.
- •Expected survival >1 month.
- •Women of child-bearing potential must use accepted contraceptive methods
- •No radiotherapy, treatment with cytotoxic agents (except CPI-613), treatment with biologic agents or any anti-cancer therapy within the 3 weeks prior to treatment with CPI-613.
排除标准
- •Serious medical illness, such as significant cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patients' risk for toxicity.
- •Patients with active central nervous system (CNS) or epidural tumor.
- •Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease).
- •Pregnant women, or women of child-bearing potential not using reliable means of contraception.
- •Lactating females because the potential of excretion of CPI-613 into breast milk.
- •Life expectancy less than 1 month.
- •Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.
研究组 & 干预措施
CPI-613
CPI-240 mg/m2
干预措施: CPI-613 (Drug)
结局指标
主要结局
To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.
时间窗: 3 weeks
次要结局
- To determine PKs of CPI-613 following IV administration.(3 weeks)