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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00771472
First received: October 9, 2008
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: vorinostat
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Clinical Study of MK-0683 in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours]) [ Time Frame: Days 1 & 28 of Cycle 1 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 10
Study Start Date: August 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vorinostat Drug: vorinostat
Parts I & II: Vorinostat (400 mg) Oral, daily (QD). Treatment period is 28 days per cycle.
Other Names:
  • MK-0683
  • Zolinza

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771472

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00771472     History of Changes
Other Study ID Numbers: 0683-089, 2008_565
Study First Received: October 9, 2008
Results First Received: May 30, 2012
Last Updated: March 18, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014