NCT03555955已完成1 期
A Phase 1 Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351 (Daunorubicin and Cytarabine) Liposome for Injection Treatment in Adult Patients With Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 13
- 主要终点
- Pharmacokinetics (PK) of CPX-351
研究概览
简要总结
This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Ability to understand and voluntarily give informed consent.
- •Male or female patients, age ≥18 years at the time of consent.
- •Diagnosis of hematologic malignancy including, but not limited to, AML, ALL, and MDS. Patients may be newly diagnosed, refractory to initial treatment, or in relapse.
- •Patients with normal renal function, or moderate or severe renal impairment as categorized by creatinine clearance (CrCl)) using the Cockcroft-Gault Formula.
- •Consent of female patients to use a medically acceptable method of contraception for at least 2 months prior to the first dose of CPX-351 and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of CPX-
- •Male patients must be willing to refrain from sperm donation for 6 months following the last dose of CPX-351and must use adequate contraception throughout the entire study period and for 6 months following the last dose of CPX-351.
排除标准
- •Prior treatment with CPX-351 ≤ to 1 month before the start of CPX-351 in this study.
- •Patients with active (uncontrolled, metastatic) second malignancies are excluded.
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent obtaining informed consent.
- •Patients with known hypersensitivity to cytarabine, daunorubicin, or liposomal products.
- •Female patients who are pregnant, nursing, or lactating.
- •Participation in another clinical trial of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to enrollment in this study.
- •Any other condition that would cause a risk to patients if they participate in the trial.
研究组 & 干预措施
Cohort 2
Experimental
Moderate renal impairment
干预措施: CPX-351 (Drug)
Cohort 1
Experimental
Normal renal function
干预措施: CPX-351 (Drug)
Cohort 3
Experimental
Severe renal impairment
干预措施: CPX-351 (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of CPX-351
时间窗: Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start.
The key PK parameter AUCtau will be assessed
次要结局
- Incidence of Treatment Emergent Adverse Events (TEAEs)(Up to 31 months.)
- PK parameter of the individual components of CPX-351, and their respective metabolites(Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start.)
研究者
研究点 (13)
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