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

NCT ID: NCT00419367

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief 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.

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK0683-042

Identifier Type: -

Identifier Source: secondary_id

2006_540

Identifier Type: -

Identifier Source: secondary_id

2006-003879-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0683-042

Identifier Type: -

Identifier Source: org_study_id