NCT00098332已完成1 期
A Phase I, Multi-Center, Open-Label, Safety and Pharmacokinetic, Repeat-Dose Study of Oral Forodesine Hydrochloride in Patients With Refractory Cutaneous T-Cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 10
研究概览
简要总结
RATIONALE: Forodesine (BCX-1777) may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory stage IIA, stage IIB, stage III, stage IVA, or stage IVB cutaneous T-cell lymphoma.
详细描述
OBJECTIVES:
- Determine the safety and efficacy of forodesine (BCX-1777) in patients with refractory stage IIA-IVB cutaneous T-cell lymphoma.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral forodesine (BCX-1777) once daily on days 1-28. Courses may be repeated in the absence of disease progression or unacceptable toxicity.
Patients are followed periodically.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed cutaneous T-cell lymphoma
- •Refractory to prior treatment
- •Stage IIA, IIB, III, IVA, or IVB disease
- •Measurable disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Not specified
- •AST and/or ALT ≤ 3 times upper limit of normal
- •Hepatitis B and/or hepatitis C negative
- •Creatinine clearance ≥ 40 mL/min
- •Immunologic
- •Human T-cell lymphotrophic virus type I (HTLV-I) negative
- •HIV negative
- •No active serious infection not controlled by antibiotics
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known impaired absorption of the gastrointestinal tract
- •No other illness that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •More than 21 days since prior chemotherapy and recovered
- •Endocrine therapy
- •Concurrent topical corticosteroids allowed provided patient remains on a stable dose
- •Radiotherapy
- •No concurrent radiotherapy
- •Not specified
- •More than 30 days since prior investigational agents and recovered
- •No concurrent tanning bed use
- •No other concurrent therapy for cutaneous T-cell lymphoma
排除标准
- 未提供
研究者
研究点 (10)
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