Status:
TERMINATED
An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an investigational study that increases the dosage to determine the safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with Targretin in patients with cutaneou...
Eligibility Criteria
Inclusion
- Women or men greater than or equal to 18 years of age
- Advanced cutaneous T-cell lymphoma, stage IB or higher including Sezary Syndrome with progressive, persistent, or recurrent disease
- Failure of at least one systemic therapy, not including Bexarotene (Targretin)
- Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2 (measurement to determine your ability to perform daily activities)
Exclusion
- Patient has had investigational treatment in the preceding 30 days
- Active hepatitis B or C, history of HIV
- Prior treatment with any HDAC inhibitor
- Patients must be disease free from prior malignancies for greater than 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00127101
Start Date
September 1 2005
End Date
October 1 2008
Last Update
April 21 2015
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