NCT00419367No Longer Available不适用
Compassionate Use of Vorinostat (MK0683) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
In an effort to allow patients continued access to vorinostat outside of the base study, patients that are actively receiving study medication will discontinue from this study and receive vorinostat via another method supported by the SPONSOR (e.g. Named Patient Program (NPP)). For those institutions that do not allow receipt of an investigational therapy outside of a clinical trial, patients that are actively receiving study medication and
continue to meet eligibility will transition to an extension phase of the study and the base study will be closed.
The extension phase will begin as soon as the protocol amendment is implemented.
研究设计
- 研究类型
- Expanded Access
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
- •Advanced cutaneous T-cell lymphoma on or following two systemic therapies
- •Female participants must have a negative serum pregnancy test within 3 days of the first dose of vorinostat
- •Female participants must have finished menopause, or are surgically sterilized, or agree to use 2 adequate barrier methods of contraception
- •Male participants must agree to use 2 adequate barrier methods of contraception
- •To be treated on extension phase of study participant must have been treated on the base study for Protocol 042
排除标准
- •Currently receiving any potential histone deacetylase (HDAC) inhibitor (e.g. valproic acid)
- •Currently receiving any other systemic therapy for CTCL. Corticosteroids that are similar in strength to 20 mg of prednisone daily are permitted
- •Pregnant or lactating
- •Known allergy to any component of the study drug
- •Eligible for any other study of vorinostat in CTCL patients
研究者
相似试验
已完成
2 期
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Unknown
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进行中（未招募）
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Compassionate Use of Vorinostat (MK-0683) for the Treatment of Patients with Advanced Cutaneous T-Cell LymphomaCutaneous T-cell lymphoma (CTCL)MedDRA version: 8.1Level: LLTClassification code 10011677Term: Cutaneous T-cell lymphomaEUCTR2006-003879-12-SIMerck & Co, Inc.100
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Compassionate Use of Vorinostat (MK-0683) for the Treatment of Patients with Advanced Cutaneous T-Cell Lymphoma - NDPatients with cutaneous manifestations of CTCL who have progressive, persistent, or recurrent cutaneous T-cell lymphoma on or following two systemic therapies.MedDRA version: 6.1Level: HLGTClassification code 10025321EUCTR2006-003879-12-ITMERCK SHARP DOHME100