NCT02982395终止3 期
A Phase Ⅲ Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M (Docetaxel-PM) In Bacillius Calmette-Guerin Refractory Non-Muscle Invasive Bladder Cancer
Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Recurrence free rate
研究概览
简要总结
The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of superficial transitional cell carcinoma of the bladder (Ta, T1)
- •Recurrent superficial bladder cancer refractory to Bacillus Calmette-Guerin (BCG)
- •No previous intravesical therapy for 6 weeks
- •No history of prior radiation to the pelvis
- •Peripheral neuropathy ≤ grade 1
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 t0 2
- •Adequate hematopoietic and hepatic parameters
排除标准
- •Muscle invasive disease (T2-T4)
- •Any other malignancy diagnosed within 2 years of study entry (Except basal or squamous cell skin cancers or noninvasive cancer of the cervix)
- •Participation in any other research protocol involving administration of an investigational agent within 3 months before study entry
- •History of sensitivity reaction to docetaxel
- •Prescribed immunosuppressive medications because of a confounding medical condition
- •Female patients who were pregnant or lactating
研究组 & 干预措施
Nanoxel®M
Experimental
75 mg in 100mL normal saline
干预措施: Nanoxel®M (Drug)
Mitomycin
Active Comparator
40 mg in 100mL normal saline
干预措施: Mitomycin-C (Drug)
结局指标
主要结局
Recurrence free rate
时间窗: 1 year
Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy. Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.
次要结局
- Recurrence free rate(6 months, 2 years)
- Overall survival(2 years)
- Number of participants with adverse events as assessed by CTCAE v4.0(2 years)
研究者
研究点 (1)
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