EUCTR2006-003879-12-DK进行中（未招募）不适用
Compassionate Use of Vorinostat (MK-0683) for the Treatment of Patients with Advanced Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient has cutaneous manifestations of CTCL, with progressive, persistent, or recurrent disease on or following two systemic therapies.
- •2. Patient’s age is = 18 years.
- •3. Female patient is either post menopausal, free from menses for > 2 years, surgically sterilized or willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from heterosexual activity throughout the study, starting with visit 1.
- •4. For males, patient agrees to use an adequate method of contraception for the duration of the study and for 30 days after the last dose of study medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient is currently under treatment with any potential histone deacetylase (HDAC) inhibitor (e.g., valproic acid).
- •2. Patient is currently receiving other systemic treatment for CTCL other than corticosteroids at a dose of no more than the equivalent of 20 mg of prednisone daily.
- •3. Patient is pregnant or lactating.
- •4. Patient has known allergy to any component of the study drug.
- •5. Patient is eligible for any other study of vorinostat in CTCL.
研究者
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