Compassionate Use of Vorinostat (MK0683, SAHA) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma
Information source: Merck
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma, T-Cell, Cutaneous
Intervention: vorinostat (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
This study will provide vorinostat to advanced cutaneous T-cell lymphoma (CTCL) patients who
have no other treatment options for their disease. Safety and efficacy will be evaluated.
Clinical Details
Official title: Compassionate Use of Vorinostat (MK0683, SAHA) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To provide drug on a compassionate use basis for the treatment of skin lesions in patients with CTCL who have been previously treated with at least two systemic medications
Secondary outcome: To assess the safety and efficacy of vorinostat in patients with CTCL
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient has advanced cutaneous T-cell lymphoma on or following two systemic therapies
- Patient is greater than or equal to 18 years of age
- Female patients must have a negative serum pregnancy test within 3 days of the first
dose of vorinostat.
- Female patients must have finished menopause, or are surgically sterilized, or agree
to use 2 adequate barrier methods of contraception.
- Male patients must agree to use 2 adequate barrier methods of contraception.
Exclusion Criteria:
- Patient is currently receiving any potential histone deacetylase (HDAC) inhibitor
(e. g. valproic acid)
- Patient is currently receiving any other systemic therapy for CTCL. Corticosteroids
that are similar in strength to 20 mg of prednisone daily are permitted.
- Patient is pregnant or lactating
- Patient has a known allergy to any component of the study drug
- Patient is eligible for any other study of vorinostat in CTCL patients
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme IDEA, Inc., Zagreb 10 010, Croatia; Recruiting
Goranka Glad Scherr, Phone: 385 1 66 44 336
Merck Sharp & Dohme, Glostrup 2600, Denmark; Recruiting
Christina Wengel, Phone: 45-43-28-77-90
MSD Finland Oy, Espoo 2151, Finland; Recruiting
Eero Helve, Phone: 358-9-804-65280
Msd Sharp & Dohme Gmbh, Haar 85540, Germany; Recruiting
Thomas Lang, Phone: 49-89-4561-1536
Merck Sharp & Dohme (Italia) S.P.A., Roma 191, Italy; Recruiting
Gianfranco Botta, Phone: 39 06 36 191187
MSD Polska Sp. z o.o. Dzial Medyczny, Warszawa 00-867, Poland; Recruiting
Adam Czernik, Phone: 48 22 549-51-39
Merck Sharp & Dohme Idea, Inc, Ljubljana, Slovenia; Recruiting
Karmen Letonja, Phone: 386 1 5204 214
Merck Sharp & Dohme (Ireland), Leopardtown, Dublin 18, Ireland; Recruiting
Colm Galligan, Phone: 353-1-2998770
MSD (Pty) LTD South Africa, Midrand, Gauteng 1685, South Africa; Recruiting
Beverley Cowper, Phone: 27 11 655-3036
Merck Sharp & Dohme Farmaceutica Ltda., Sao Paulo, SP 04717-004, Brazil; Recruiting
Jose Octavio P. Costa Filo, Phone: 55-11-5189-7942
Additional Information
(MedWatch - FDA maintained medical product safety Information) (PhRMA Clinical Study Results Database - web-based repository for clinical study results) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: April 2007
Last updated: October 15, 2008
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