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

• Conditions: Cutaneous T-cell lymphoma (CTCL); MedDRA version: 8.1Level: LLTClassification code 10011677Term: Cutaneous T-cell lymphoma

• Registration Number: EUCTR2006-003879-12-DE
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-03
• Last Update Posted: 27 January 2014

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 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

Exclusion Criteria

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.

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: To assess the safety and tolerability of treatment with vorinostat in patients with CTCL in a compassionate use setting. To assess the efficacy of vorinostat in patients with CTCL in a compassionate use setting.;Primary end point(s): The primary efficacy endpoint is the response rate to oral vorinostat in patients with advanced CTCL as measured by the physician assessment.