A Phase 1, First-in-Human, Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CicloMed LLC
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- Determine the Maximum Tolerated Dose (MTD) of CPX-POM
研究概览
简要总结
This is a first-in-human, Phase I, multicenter, open label, dose escalation study to evaluate the DLTs and MTD and to determine the recommended Phase 2 dose (RP2D) of CPX-POM administered IV in patients with any histologically- or cytologically-confirmed solid tumor type.
详细描述
The study will initially employ an accelerated escalation design, with a single patient enrolled in each cohort (i.e., Single-Patient Cohorts). The initial patient will receive CPX-POM at a starting dose of 30 mg/m2. Doses will be escalated (doubling), until a ≥Grade 2 toxicity (with the exception of alopecia), is encountered. Subsequently that and all subsequent cohorts will follow a classical "3+3" dose escalation design.
Note: Fosciclopirox is the generic name for CPX-POM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
研究组 & 干预措施
CPX-POM - 30 mg/m^2
干预措施: CPX-POM - 30 mg/m^2 (Drug)
CPX-POM - 60 mg/m^2
干预措施: CPX-POM - 60 mg/m^2 (Drug)
CPX-POM - 120 mg/m^2
干预措施: CPX-POM - 120 mg/m^2 (Drug)
CPX-POM - 240 mg/m^2
干预措施: CPX-POM - 240 mg/m^2 (Drug)
CPX-POM - 360 mg/m^2
干预措施: CPX-POM - 360 mg/m^2 (Drug)
CPX-POM - 600 mg/m^2
干预措施: CPX-POM - 600 mg/m^2 (Drug)
CPX-POM - 900 mg/m^2
干预措施: CPX-POM - 900 mg/m^2 (Drug)
CPX-POM - 1200 mg/m^2
干预措施: CPX-POM - 1200 mg/m^2 (Drug)
结局指标
主要结局
Determine the Maximum Tolerated Dose (MTD) of CPX-POM
时间窗: Days 1, 2, 3, 4, 5, 6, 10, 22 and 28
The primary objective of this study is to evaluate the maximum tolerated dose (MTD) of ciclopirox phosphoryloxymethyl ester (CPX-POM) administered intravenously (IV) and establish the CPX POM dose recommended for further investigation. MTD was determined by testing increasing doses up to 1200 mg/m\^2 by IV. The MTD is defined as the dose BELOW that dose which causes DLTs in ≥33% of patients.
Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM
时间窗: Up to 22 days for each cohort
The primary objective of this study is to evaluate the dose limiting toxicities (DLTs) of ciclopirox phosphoryloxymethyl ester (CPX-POM) administered intravenously (IV) and establish the CPX POM dose recommended for further investigation. A DLT will include some Grade 3 or 4 AEs (as assessed by CTCAE version 4.03) if deemed related to study drug. In addition, any patient who is unable to receive 80% of the expected dose of CPX-POM (i.e., patients who are unable to receive at least 4 of the 5 scheduled doses) because of AEs will be considered to have a DLT. In order to identify any DLTs, safety assessments including AEs, physical examinations, vital signs, and clinical laboratory tests will be conducted during each study visit through Day 22.
次要结局
- Assess Plasma PK: Terminal Half-life of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.(Days 5-6)
- Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.(Days 5-6)
- Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing.(Days 5-6)
- Assess Urine PK: Average 24-hour Urine Concentration of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.(Days 5-6)
- Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.(Days 5-6)
- Assess Plasma PK: Cmax (ng/mL) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.(Days 5-6)
- Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.(Days 5-6)
- Characterize Plasma PK: AUCss/AUCi Accumulation Ratio of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.(Days 5-6)