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NCT00419367 Clinical Trial

Compassionate Use of Vorinostat for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma (0683-042)

Lymphoma, T-Cell, Cutaneous Clinical Trial

Official title:
Compassionate Use of Vorinostat (MK0683) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00419367
Other study ID # 0683-042
Secondary ID MK0683-0422006_5
Status No longer available
Phase
First received
Last updated

Study information
Verified date September 2022
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Comparator: vorinostat
Each patient will receive open-label vorinostat 400 mg q.d. capsules. Treatment will continue until disease progression, intolerable toxicity, withdrawal of consent, or physician determines it is in best interest of patient to withdrawal.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme LLC
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