Phase 1 Trial Evaluating the Safety and Tolerability of NanoDoce® Intratumoral Injection in Subjects With Localized Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Number of participants with treatment emergent adverse events
研究概览
简要总结
This study evaluates the use of NanoDoce injected directly into tumors in the kidney of people with renal cell carcinoma.
详细描述
NanoDoce is very small (submicron) particles of the chemotherapy drug, docetaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle docetaxel will be injected directly into tumors in the kidney of people with renal cell carcinoma that is localized to (has not spread beyond) the kidney. All subjects in this study will receive NanoDoce and will be evaluated to see if NanoDoce is safe.
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;
- •Age ≥18 years;
- •Localized T1a renal cell carcinoma;
- •Maximum tumor volume of 25.0 mL;
- •Performance Status (ECOG) 0-2;
- •Life expectancy of at least 6 months;
- •Adequate marrow, liver, and renal function;
- •ANC ≥ 1.5 x 109/L
- •Hemoglobin ≥ 9.5 grams/dL
- •Platelets ≥ 75 x 109/L
- •Total bilirubin ≤ 1.5x institutional ULN
- •AST/ ALT ≤ 2.5x institutional ULN
- •Creatinine ≤ 1.5x institutional ULN
- •eGFR < 60 mL/min/1.73m2
- •Adequate method of birth control.
排除标准
- •Renal cyst;
- •Multifocal or bilateral renal mass;
- •Known hypersensitivity to any of the study drug or reconstitution components;
- •Pregnant or breastfeeding female;
- •Administration of an investigational product in a clinical trial within 3 months prior to consent;
- •Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
- •Known drug or alcohol abuse.
研究组 & 干预措施
NanoDoce
Intratumoral injection of NanoDoce (2.0 to 6.0 mg/mL) at a volume not to exceed 5.0 mL. NanoDoce will be administered on up to two occasions with at least 4 weeks between doses.
干预措施: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension (Drug)
结局指标
主要结局
Number of participants with treatment emergent adverse events
时间窗: Day 1 to 180 days post-last NanoDoce injection
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
次要结局
- Concentration of docetaxel in the systemic circulation post-injection(Screening, Day 1, Day 2, Day 15, Day 27, Day 30, Day 31, Day 45, Month 2, Month 3, Month 4, Month 5, and 180 days post-last NanoDoce injection)