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

• Conditions: Patients 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 10025321

• Registration Number: EUCTR2006-003879-12-IT
• Lead Sponsor: MERCK SHARP DOHME

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To provide drug on a compassionate use basis for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent, or recurrent disease on or following two systemic therapies and who would not otherwise have access to vorinostat.;Secondary Objective: 1) To assess the safety and tolerability of treatment with vorinostat in patients with CTCL in a compassionate use setting. Hypothesis: Oral vorinostat at a dose of 400 mg once daily is well-tolerated in patients with CTCL. 2) To assess the efficacy of vorinostat in patients with CTCL in a compassionate use setting. Hypothesis: Oral vorinostat at a dose of 400 mg once daily is effective in a substantial proportion of patients with CTCL.;Primary end point(s): The primary efficacy endpoint is the response rate to oral vorinostat in patients with CTCL who have progressive, persistent or recurrent disease on or following two systemic therapies as measured by the physician assessment.