NCT00091559已完成2 期
Phase IIb Multicenter Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Cutaneous T-cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Objective response rate in patients with progressive, persistent, or recurrent disease.
研究概览
简要总结
A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained Targretin (bexarotene)or for patients who are not candidates or could not tolerate Targretin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with Cutaneous T-cell Lymphoma (Stage 1B or higher)
- •Age: over 18 years of age
- •Have the ability to swallow capsules.
- •You must be at least 3 weeks from any prior chemotherapy or anticancer therapy treatment and have recovered from any side effects of that treatment.
- •Patients also require adequate heart, liver, and kidney function.
排除标准
- •Pregnant and nursing women and those with known allergy to the study drug are excluded from this study.
- •Patients are excluded if they are currently receiving chemotherapy, radiation therapy, or other investigational anti-cancer therapy.
- •Patients diagnosed with HIV, active hepatitis or who require intravenous antibiotics or antifungal agents are not permitted.
结局指标
主要结局
Objective response rate in patients with progressive, persistent, or recurrent disease.
次要结局
- Response duration, relief of pruritis, time to progression, time to objective response, safety & tolerability in this population.
研究者
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