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Completed

NCT Number: NCT00771472

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

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vorinostat

Drug

Parts I & II: Vorinostat (400 mg) Oral, daily (QD). Treatment period is 28 days per cycle.

Other names: MK-0683, Zolinza

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 13, 2008
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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