Status:
COMPLETED
Vorinostat (MK-0683) Phase I Study in Cutaneous T-Cell Lymphoma (CTCL) Patients (MK-0683-089 EXT1)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Lymphoma
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in Japanese pts. wit...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Parts I \& II):
- Patients With CTCL Who Have Progressive, Persistent Or Recurrent Disease Subsequent To At Least One Prior Therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status Must Be 0-2
- Patients Have Adequate Bone Marrow, Liver Function And Renal Function
- Exclusion Criteria (Parts I \& II):
- Patients Had Prior Therapy Within 3 Weeks Before Registration, Or Have Not Recovered From Toxicities Of Prior Therapy
- Patients Have Uncontrolled Intercurrent Illness
- Pregnant Or Women Have A Will To Be Pregnant And Lactating Woman
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00771472
Start Date
August 1 2008
End Date
July 1 2011
Last Update
April 21 2015
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