NCT01316874已完成2 期
Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-Guerin (BCG)
Endo Pharmaceuticals39 个研究点 分布在 1 个国家目标入组 90 人开始时间: 1993年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 39
- 主要终点
- Assess the efficacy of AD 32 (valrubicin) in patients with CIS of the bladder who previously have been treated with BCG for CIS and in whom recurrence or failure had occurred after multiple courses of intravesical treatment.
研究概览
简要总结
This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus Calmette-Guerin (BCG) for CIS and in whom recurrence or failure has occurred after multiple courses of intravesical treatment.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AD32 (valrubicin)
Experimental
800mg, once weekly for 6 weeks
干预措施: Valrubicin, 800 mg (Drug)
结局指标
主要结局
Assess the efficacy of AD 32 (valrubicin) in patients with CIS of the bladder who previously have been treated with BCG for CIS and in whom recurrence or failure had occurred after multiple courses of intravesical treatment.
时间窗: 12 weeks
次要结局
- To determine the concentration of anthracyclines in the voided urine of patients who chose to participate in a urine recovery study.(6 weeks)
- To evaluate the qualitative toxicities associated with intravesical therapy using AD 32 (valrubicin).(6 weeks)
研究者
研究点 (39)
Loading locations...
相似试验
已完成
2 期
Chemotherapy in Treating Patients With Early-Stage Bladder CancerBladder CancerNCT00003129Eastern Cooperative Oncology Group75
进行中（未招募）
2 期
Intravesical Gem/Doce in Patients With NMIBCUrinary Bladder CancerNCT05644041University of Arizona31
已完成
2 期
Intravesical Chemotherapy Treatment of Superficial Bladder CancerBladder NeoplasmsNCT00491114Eli Lilly and Company8
已完成
2 期
Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer TreatmentBladder CancerNCT01489813Emory University36
已完成
2 期
Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.BCR-ABL1 Fusion Protein ExpressionBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositivePhiladelphia Chromosome PositiveRecurrent Acute Lymphoblastic Leukemiat(9;22)Acute Lymphoblastic LeukemiaNCT00390793M.D. Anderson Cancer Center107