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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I Clinical Study of MK-0683 in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)

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

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE) [ Time Frame: Day 1 up until 30 days post study completion or early termination (up to approximately 506 days) ]
    A laboratory AE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body.
  • Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT) [ Time Frame: Day 1 to Day 28 ]

    A DLT was defined as any of the following (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0):

    • Grade 3 (severe)-4 (life-threatening) neutropenia with fever ≥ 38.5ºC
    • Grade 3-4 neutropenia with an infection requiring antibiotic or antifungal treatment
    • Grade 4 neutropenia lasting at least 5 days
    • Grade 4 thrombocytopenia
    • Other Grade 4 hematologic toxicity, including a decrease in hemoglobin, only at the discretion of the principal investigator
    • Grade 3 or 4 non-hematologic event, except which are manageable by supportive care or non-prohibited therapies


Original Primary Outcome: Any clinical or laboratory adverse experiences [ Time Frame: 21 days ]

Current Secondary Outcome:

  • Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours]) [ Time Frame: Days 1 & 28 of Cycle 1 ]

    Blood samples taken as follows:

    Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat.

  • Part I: Maximum Drug Concentration (Cmax) [ Time Frame: Days 1 & 28 of Cycle 1 ]

    Blood samples taken as follows:

    Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat.

  • Part I: Time at Which Cmax Occurs (Tmax) [ Time Frame: Days 1 & 28 of Cycle 1 ]

    Blood samples taken as follows:

    Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat.

  • Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2) [ Time Frame: Days 1 & 28 of Cycle 1 ]

    Blood samples taken as follows:

    Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat.



Original Secondary Outcome: Pharmacokinetics [ Time Frame: 21 days ]

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: October 9, 2008
Date Started: August 2008
Date Completion:
Last Updated: April 2, 2015
Last Verified: April 2015