NCT01215877Unknown2 期
A Phase II Study of Tesetaxel in Subjects Previously Treated With Chemotherapy for Metastatic Transitional Cell Carcinoma of the Urothelium
Genta Incorporated5 个研究点 分布在 2 个国家目标入组 33 人开始时间: 2010年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 33
- 试验地点
- 5
- 主要终点
- Response rate (revised RECIST)
研究概览
简要总结
The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination with other chemotherapy agents are active in patients with advanced and metastatic bladder cancer, and agents of this class are a promising treatment option for some patients.
Tesetaxel is an orally administered taxane that is in development as treatment for subjects with advanced cancers. This study is being conducted to determine the efficacy and safety of tesetaxel administered to patients previously treated with chemotherapy for progressive metastatic transitional cell carcinoma of the urothelium.
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
- •At least 18 years of age
- •Histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis
- •Measurable disease (revised RECIST; Version 1.1)
- •Karnofsky performance status ≥ 60%
- •Previously treated with not more than 1 doublet or triplet regimen and that regimen contained gemcitabine and a platinum agent
- •Adequate bone marrow, hepatic, and renal function, as specified in the protocol
- •At least 4 weeks and recovery from effects of prior surgery, prior radiotherapy, or other therapy with an approved or investigational agent
- •Ability to swallow an oral solid-dosage form of medication
排除标准
- •Known metastasis or symptoms of metastasis to the central nervous system
- •Significant medical disease other than cancer
- •Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
- •Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
- •Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
结局指标
主要结局
Response rate (revised RECIST)
时间窗: 12 months from date of first dose of study medication for last patient enrolled
Proportion of patients with a confirmed complete or partial response
次要结局
- ≥ 3-month response rate(12 months from date of first dose of study medication for last patient enrolled)
- Disease control rate(12 months from date of first dose of study medication for last patient enrolled)
- Durable response rate(12 months from date of first dose of study medication for last patient enrolled)
- Duration of response(12 months from date of first dose of study medication for last patient enrolled)
- Time to progression(12 months from date of first dose of study medication for last patient enrolled)
- Safety(Up to 30 days after the last dose of study medication for a specific patient)
研究者
研究点 (5)
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