NCT01296243Unknown2 期
A Phase II Study of Single-agent Tesetaxel in Chemotherapy-naive Patients Who Have Progressive, Castration-resistant Prostate Cancer
Genta Incorporated4 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- Progression-free survival
研究概览
简要总结
Given the activity of docetaxel in patients with progressive, metastatic castration-resistant prostate cancer, this study is being undertaken to evaluate the activity of tesetaxel, an orally bioavailable taxane, in chemotherapy-naive and chemotherapy-exposed patients.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Histologically confirmed prostate cancer, currently with progressive disease
- •Evidence of metastatic disease
- •Castrate level of testosterone (< 50 ng/dL)
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •Chemotherapy-naïve
- •Adequate bone marrow, hepatic, and renal function
- •Ability to swallow an oral solid-dosage form of medication
排除标准
- •History or presence of brain metastasis or leptomeningeal disease
- •Operable cancer
- •Uncontrolled diarrhea
- •Uncontrolled nausea or vomiting
- •Known malabsorptive disorder
- •Currently active second malignancy other than non-melanoma skin cancers
- •Human immunodeficiency virus (HIV) infection based on history of positive serology
- •Significant medical disease other than cancer
- •Presence of neuropathy > Grade 2 (National Cancer Institute Common Toxicity Criteria [NCI CTC]; v4.0)
- •Need for other anticancer treatment
- •Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
- •Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
- •Less than 4 weeks since use of another investigational agent
研究组 & 干预措施
Tesetaxel once every 3 weeks
Experimental
干预措施: Tesetaxel (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 6 months from the start of treatment
次要结局
- Response rate (RECIST 1.1) among patients with measurable disease(6 months from the start of treatment)
- No. (percentage) of subjects with adverse events(Through 30 days after the last dose of tesetaxel)
- Duration of response among patients with measurable disease(12 months from the start of treatment)
- Progression-free survival(12 months from the start of treatment)
- Disease-control rate(6 months from the start of treatment)
- Overall survival(3 years following enrollment of the last subject)
- Durable response among patients with measurable disease(12 months from the start of treatment)
- PSA response rate(Week 12)
研究者
研究点 (4)
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