Compassionate Use of Vorinostat (MK-0683) for the Treatment of Patients with Advanced Cutaneous T-Cell Lymphoma - ND

MERCK SHARP DOHME0 个研究点目标入组 100 人开始时间: 2007年12月10日最近更新: 2012年3月19日

研究概览

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•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 patients of childbearing potential must have a negative serum pregnancy test (βhCG) within 72 hours of receiving the first dose of vorinostat. 4. 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. 5. Male, patient agrees to use an adequate method of contraception for the duration of the study. 6. Patient has ability to understand and willingness to sign the informed consent form.
•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

•1. Patient is currently under treatment with any potential 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.

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