CompletedPhase 1

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

10 participantsStarted 2008-08

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

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)

Timeframe: Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)

Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)

Timeframe: Day 1 to Day 28

Trial details

NCT IDNCT00771472

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-07

Results submitted2012-05-30

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