Vorinostat (MK-0683) Phase I Study in Cutaneous T-Cell Lymphoma (CTCL) Patients (MK-0683-089 EXT1)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Lymphoma

Treatments

Drug: vorinostat

Study type

Interventional

Funder types

Industry

Identifiers

NCT00771472

2008_565

0683-089

Details and patient eligibility

About

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. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be newly enrolled in Part II.

Enrollment

10 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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