NCT00046943已完成3 期
A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer
Abbott1 个研究点 分布在 1 个国家开始时间: 2002年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase III trial to determine the effectiveness of atrasentan in treating patients who have prostate cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES:
- Determine the safety of atrasentan in patients with hormone-refractory prostate cancer.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral atrasentan once daily for 3 years in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month and then every 3 months for 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of hormone-refractory prostate cancer
- •Completed protocol ABBOTT-M00-211 or ABBOTT-M00-244 within the past 30 days
- •Disease progression OR
- •Active in trial when double-blind treatment period ended
- •PATIENT CHARACTERISTICS:
- •19 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC at least 3,000/mm3
- •Absolute neutrophil count greater than 1,000/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin at least 9 g/dL
- •Bilirubin less than 1.5 mg/dL
- •AST and ALT no greater than 1.5 times upper limit of normal
- •Creatinine clearance at least 40 mL/min
- •Cardiovascular
- •No New York Heart Association class II-IV heart disease
- •No significant pulmonary disease requiring chronic or pulse steroid therapy within the past 3 months
- •Fertile patients must use 2 effective methods of contraception (1 must be barrier contraception) during and for 8 weeks after study
- •No reason that would preclude study
- •No significant comorbid condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 4 weeks since other prior cytotoxic chemotherapy
- •No other concurrent cytotoxic chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 4 weeks since prior radionuclides
- •No concurrent radionuclides
- •Not specified
- •At least 4 weeks since prior investigational agents
- •No concurrent antiretroviral therapy for HIV-positive patients
- •No concurrent participation in another investigational study
排除标准
- 未提供
研究者
研究点 (1)
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