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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
vorinostat
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Vorinostat

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Full Information

    First Posted
    October 9, 2008
    Last Updated
    April 2, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00771472
    Brief Title
    Vorinostat (MK-0683) Phase I Study in Cutaneous T-Cell Lymphoma (CTCL) Patients (MK-0683-089 EXT1)
    Official Title
    Phase I Clinical Study of MK-0683 in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vorinostat
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    vorinostat
    Other Intervention Name(s)
    MK-0683, Zolinza
    Intervention Description
    Parts I & II: Vorinostat (400 mg) Oral, daily (QD). Treatment period is 28 days per cycle.
    Primary Outcome Measure Information:
    Title
    Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)
    Description
    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.
    Time Frame
    Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)
    Title
    Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)
    Description
    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
    Time Frame
    Day 1 to Day 28
    Secondary Outcome Measure Information:
    Title
    Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours])
    Description
    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.
    Time Frame
    Days 1 & 28 of Cycle 1
    Title
    Part I: Maximum Drug Concentration (Cmax)
    Description
    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.
    Time Frame
    Days 1 & 28 of Cycle 1
    Title
    Part I: Time at Which Cmax Occurs (Tmax)
    Description
    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.
    Time Frame
    Days 1 & 28 of Cycle 1
    Title
    Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)
    Description
    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.
    Time Frame
    Days 1 & 28 of Cycle 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22506596
    Citation
    Wada H, Tsuboi R, Kato Y, Sugaya M, Tobinai K, Hamada T, Shimamoto T, Noguchi K, Iwatsuki K. Phase I and pharmacokinetic study of the oral histone deacetylase inhibitor vorinostat in Japanese patients with relapsed or refractory cutaneous T-cell lymphoma. J Dermatol. 2012 Oct;39(10):823-8. doi: 10.1111/j.1346-8138.2012.01554.x. Epub 2012 Apr 16.
    Results Reference
    result

    Learn more about this trial

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

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