NCT01284205撤回3 期
Randomized, Double-blind, Multi-center Study Comparing MCC to BCG as First Line Immunotherapy in Patients With Non-muscle Invasive (Superficial) Bladder Cancer at High Risk of Recurrence or Progression
Bioniche Life Sciences Inc.14 个研究点 分布在 1 个国家开始时间: 2010年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 14
- 主要终点
- Duration of disease-free survival (time to recurrence, progression or death) in all patients
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •histologically confirmed urothelial carcinoma of the bladder (high grade Ta or T1 papillary lesions, CIS)
- •histologically confirmed diagnosis within 42 days of study treatment
- •life expectancy of greater than 5 years
- •ECOG performance status of 2 or less
- •absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from start of study treatment
排除标准
- •current or previous history of muscle invasive bladder tumors (>T2)
- •current or previous history of lymph node and/or distant metastases from bladder cancer
- •current evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the bladder
- •current systemic cancer therapy
- •previous immunotherapy for bladder cancer
- •previous intravesical chemotherapy treatment
- •contraindication to use BCG of known tolerance to BCG
- •history of malignancy of any organ system within the past 5 years (with the exception of basal cell or squamous cell carcinoma, stage T1 prostate cancer, carcinoma in situ of the cervix, colon polyps)
- •patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy)
结局指标
主要结局
Duration of disease-free survival (time to recurrence, progression or death) in all patients
时间窗: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
Percent of patients who due to study drug-related AEs experience 2 consecutive treatment delays or discontinue due to drug related AEs
时间窗: Baseline through 24 months
次要结局
- Duration of progression-free survival (time to progression or death) in all patients(Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60)
- Frequency, severity, and nature of drug-related SAEs(Baseline through 24 months)
- Frequency, severity, and nature of drug-related AEs(Baseline through 24 Months)
- Number of treatment discontinuations and their reason(Baseline through 24 months)
- Disease-free survival rate at 2 years(Month 24)
- Number of treatment delays and their reason(Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24)
- Frequency, severity and nature of all AEs(Baseline through 24 months)
- Duration of Survival (time to death from any cause) in all patients(Baseline through month 60)
研究者
研究点 (14)
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