Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects With Urothelial Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation. All participants will receive NanoDoce, and will be evaluated for safety and tolerability, as well as the potential effects of NanoDoce on urothelial carcinoma.
详细描述
In this clinical trial, subjects with high-risk non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC), will receive NanoDoce. Subjects will be stratified into two treatment groups, Group 1 (NMIBC) and Group 2 (MIBC). All subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT), followed by an initial NanoDoce intravesical instillation.
Once the TURBT resection site is healed (approximately 1 month), Group 1 (NMIBC) subjects will proceed to a 3-month Induction period (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest). After the Induction period, following confirmation of non-recurrence, Group 1 subjects will proceed to a 3-month Maintenance period (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest).
After NanoDoce direct injection and the initial intravesical instillation, Group 2 subjects will proceed to institutional standard of care and will not receive Induction or Maintenance intravesical instillations.
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
- •Signed informed consent;
- •Age ≥18 years;
- •Patients with either:
- •High-risk Non-Muscle Invasive Bladder Cancer (NMIBC);
- •Muscle Invasive Bladder Cancer (MIBC);
- •Urothelial carcinoma confirmed by biopsy, urine cytology, computed tomography scan (CT) or other institution-approved diagnostic methodology;
- •All visible tumors removed during bladder resection (TURBT);
- •Performance Status (ECOG) 0-2 at study entry;
- •Life expectancy of at least 6 months;
- •Adequate marrow, liver, and renal function;
- •ANC ≥ 1.5 x 10^9/L;
- •Hemoglobin ≥ 9.5 grams/dL;
- •Platelets ≥ 75 x 10^9/L;
- •Total bilirubin ≤ 1.5x institutional ULN;
- •AST/ ALT ≤ 2.5x institutional ULN;
- •Creatinine ≤ 1.5x institutional ULN;
- •Adequate method of birth control.
排除标准
- •Metastatic disease;
- •Previous (within 12 months) or concurrent history of non-bladder malignancy, except for non-melanoma skin cancer;
- •Intravesical therapy within 6 weeks prior to consent (chemotherapy or immunotherapy including BCG administered directly into the bladder);
- •Resection surface area greater than 8 cm2;
- •Upper tract and urethral disease within 18 months;
- •Known hypersensitivity to any of the study drug components or reconstitution components;
- •Pregnant or breastfeeding;
- •Participation in the treatment phase of another 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;
- •Ongoing drug or alcohol abuse.
研究组 & 干预措施
Non-Muscle Invasive Bladder Cancer
Subjects will be enrolled in sequential, dose escalating cohorts of NanoDoce direct injection (0.75, 1.5, 2.5, or 3.75 mg/mL). Subjects will also receive an initial NanoDoce intravesical instillation at 2.0 or 3.0 mg/mL and additional Induction (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and Maintenance (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest) instillations at 2.0 or 3.0 mg/mL.
干预措施: NanoDoce (direct injection) (Drug)
Non-Muscle Invasive Bladder Cancer
Subjects will be enrolled in sequential, dose escalating cohorts of NanoDoce direct injection (0.75, 1.5, 2.5, or 3.75 mg/mL). Subjects will also receive an initial NanoDoce intravesical instillation at 2.0 or 3.0 mg/mL and additional Induction (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and Maintenance (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest) instillations at 2.0 or 3.0 mg/mL.
干预措施: NanoDoce (intravesical instillation) - Visit 2 Instillation (Drug)
Non-Muscle Invasive Bladder Cancer
Subjects will be enrolled in sequential, dose escalating cohorts of NanoDoce direct injection (0.75, 1.5, 2.5, or 3.75 mg/mL). Subjects will also receive an initial NanoDoce intravesical instillation at 2.0 or 3.0 mg/mL and additional Induction (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and Maintenance (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest) instillations at 2.0 or 3.0 mg/mL.
干预措施: NanoDoce (intravesical instillation) - Induction and Maintenance Instillations (Drug)
Muscle Invasive Bladder Cancer
Subjects will be enrolled in sequential, dose escalating cohorts of NanoDoce direct injection (0.75, 1.5, 2.5, or 3.75 mg/mL). Subjects will also receive an initial NanoDoce intravesical instillation at 2.0 or 3.0 mg/mL. Subjects will then go on to receive institutional standard of care.
干预措施: NanoDoce (direct injection) (Drug)
Muscle Invasive Bladder Cancer
Subjects will be enrolled in sequential, dose escalating cohorts of NanoDoce direct injection (0.75, 1.5, 2.5, or 3.75 mg/mL). Subjects will also receive an initial NanoDoce intravesical instillation at 2.0 or 3.0 mg/mL. Subjects will then go on to receive institutional standard of care.
干预措施: NanoDoce (intravesical instillation) - Visit 2 Instillation (Drug)
Muscle Invasive Bladder Cancer
Subjects will be enrolled in sequential, dose escalating cohorts of NanoDoce direct injection (0.75, 1.5, 2.5, or 3.75 mg/mL). Subjects will also receive an initial NanoDoce intravesical instillation at 2.0 or 3.0 mg/mL. Subjects will then go on to receive institutional standard of care.
干预措施: Institutional Standard of Care (Other)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
时间窗: Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2)
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
次要结局
- Recurrence Free Survival (RFS)(At Months 6, 9, and 12)
- Disease Progression(Day 45)