Compassionate Use of Vorinostat for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma (0683-042) Ext 1

Expanded access is no longer available for this treatment.

First Received on January 5, 2007. Last Updated on April 3, 2012 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00419367

Purpose

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	Intervention
Lymphoma, T-Cell, Cutaneous	Drug: Comparator: vorinostat

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

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary multiple exostoses

MedlinePlus related topics: Lymphoma

Drug Information available for: Vorinostat

U.S. FDA Resources

Further study details as provided by Merck:

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419367

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00419367 History of Changes
Other Study ID Numbers:	2006_540, MK0683-042
Study First Received:	January 5, 2007
Last Updated:	April 3, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Lymphoma, Non-Hodgkin
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2012