NCT02834611已完成1 期
Phase I Study of C6 Ceramide NanoLiposome in Patients With Advanced Solid Tumors
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
- 14
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose of Ceramide NanoLiposome in patients with advanced solid tumors.
研究概览
简要总结
This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced solid tumors.
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
- •Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures.
- •18 years of age or order
- •Histologic or cytologic diagnosis of cancer
- •Patients without a curative therapy or whose tumor does not have standard chemotherapy
- •At least 4 weeks after the last dose of chemotherapy or radiation therapy; 6 weeks for mitoxantrone or mitomycin therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2 (Appendix A).
- •Adequate hepatic, renal, and bone marrow function:
- •Absolute neutrophil count ≥ 1,000/microliter (uL)
- •Platelets ≥ 100,000/uL
- •Total bilirubin ≤2.0
- •AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN
- •Creatinine ≤1.2 mg/dL or clearance ≥50ml/min (Cockcroft-Gault)
- •All participants (male and female) with reproductive potential must practice an effective method of contraception while on this study in order to minimize risks to fetuses.
- •Radiographic evidence of measurable disease tumor lesion (≥ 1cm in greatest dimension) or nodal disease (>1.5cm in greatest dimension)
- •Men and women of all ethnic groups are eligible for this trial.
- •Females at reproductive age must have a negative urine pregnancy test prior to entry to this study
- •Life expectancy is greater than 12 weeks.
- •Patients with controlled CNS disease and off steroids are eligible.
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients may not be receiving any other concurrent investigational agents, or have received any investigational agent within four weeks of commencing this protocol.
- •Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded. Males and females should perform abstinence or use barrier to prevent pregnancy.
- •History of any other malignancies in the last 2 years except in-situ cancer, non-muscle invasive bladder cancer, basal or squamous cell skin cancer are eligible
- •Patients known to be HIV(+), Hep BsAg(+), or Hep C(+) are excluded as the effect of the agent on immune system has not been assessed
- •Patients with history of hypersensitivity to liposomal products
- •Patients with primary CNS malignancies or leptomeningeal disease are excluded
研究组 & 干预措施
Ceramide NanoLiposome
Experimental
Dose escalation of Ceramide NanoLiposome
干预措施: Ceramide NanoLiposome (Drug)
结局指标
主要结局
Maximum tolerated dose of Ceramide NanoLiposome in patients with advanced solid tumors.
时间窗: 24 months
次要结局
- Recommended phase II dose(24 months)
- Peak plasma concentration (Cmax)(24 months)
- Objective response rate per RECIST v1.1(24 months)
- Ceramide NanoLiposome half-life (t1/2)(24 months)
- Incidence of treatment-related adverse events as assessed by CTCAE v4.0(24 months)
- Time to maximum plasma concentration (Tmax)(24 months)
研究者
研究点 (3)
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