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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
No longer available
CT.gov ID
NCT00419367
Collaborator
(none)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Comparator: vorinostat

Study Design

Study Type:
Expanded Access
Official Title:
Compassionate Use of Vorinostat (MK0683) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00419367
    Other Study ID Numbers:
    • 0683-042
    • MK0683-042
    • 2006_540
    First Posted:
    Jan 8, 2007
    Last Update Posted:
    Aug 14, 2019
    Last Verified:
    Aug 1, 2019
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Cutaneous
    Vorinostat

    Study Results

    No Results Posted as of Aug 14, 2019