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
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
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.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27012
- Wake Forest University Health Sciences
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:CPI-613
CPI-240 mg/m2
|
This is a Phase I open label trial using a 2-stage dose-escalation scheme (single-patient & traditional stages): Single-Patient Dose-Escalation Stage: In the single-patient stage, a single patient will be accrued per dose level. The starting dose will be 420 mg/m². Dose level will be escalated (by doubling the previous dose) if there is no toxicity or if the toxicity is grade 1 or less. If toxicity is >Grade 1, the traditional dose-escalation stage will be triggered. Traditional Dose-Escalation: All dose escalations conducted in this Traditional Dose-Escalation stage will be escalated according to the modified Fibonacci Dose-Escalation scheme. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.
大体时间:3 weeks
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3 weeks
|
次要结果测量
结果测量 |
大体时间 |
---|---|
To determine PKs of CPI-613 following IV administration.
大体时间:3 weeks
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3 weeks
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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