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A Phase II Study of MK0457 in Patients With T315I Mutant CML and Ph+All (0457-008)

Primary Purpose

Leukemia

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0457
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia

Eligibility Criteria

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

Inclusion Criteria:

  • This study will evaluate MK0457 in patients with CML (chronic myelogenous leukemia) and Ph+ALL (Philadelphia chromosome-positive acute lymphoblastic leukemia)
  • Patients must have adequate organ function
  • Patients must have documented T315I mutation

Exclusion Criteria:

  • Patients within 3 months of allogeneic bone marrow transplant or not fully recovered from previous anti-leukemia therapy
  • Patients with uncontrolled congestive heart failure
  • Patients with active or uncontrolled infection or active Hepatitis B or C
  • Patients with known HIV positivity or AIDS related illness
  • Patients with currently active second malignancy, other than non-melanoma skin cancer.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    1

    Arm Description

    continuous infusion every 14 days

    Outcomes

    Primary Outcome Measures

    efficacy

    Secondary Outcome Measures

    Full Information

    First Posted
    November 28, 2006
    Last Updated
    January 23, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00405054
    Brief Title
    A Phase II Study of MK0457 in Patients With T315I Mutant CML and Ph+All (0457-008)
    Official Title
    A Phase II Study of MK0457 in Patients With T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This study will evaluate MK0457 in patients with chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Efficacy and safety will be evaluated.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Other
    Arm Description
    continuous infusion every 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    MK0457
    Intervention Description
    IV infusion 32 mg/m2/hour; 5-day continuous infusion every 14 days
    Primary Outcome Measure Information:
    Title
    efficacy
    Time Frame
    24 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: This study will evaluate MK0457 in patients with CML (chronic myelogenous leukemia) and Ph+ALL (Philadelphia chromosome-positive acute lymphoblastic leukemia) Patients must have adequate organ function Patients must have documented T315I mutation Exclusion Criteria: Patients within 3 months of allogeneic bone marrow transplant or not fully recovered from previous anti-leukemia therapy Patients with uncontrolled congestive heart failure Patients with active or uncontrolled infection or active Hepatitis B or C Patients with known HIV positivity or AIDS related illness Patients with currently active second malignancy, other than non-melanoma skin cancer.
    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
    25127392
    Citation
    Seymour JF, Kim DW, Rubin E, Haregewoin A, Clark J, Watson P, Hughes T, Dufva I, Jimenez JL, Mahon FX, Rousselot P, Cortes J, Martinelli G, Papayannidis C, Nagler A, Giles FJ. A phase 2 study of MK-0457 in patients with BCR-ABL T315I mutant chronic myelogenous leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia. Blood Cancer J. 2014 Aug 15;4(8):e238. doi: 10.1038/bcj.2014.60.
    Results Reference
    result

    Learn more about this trial

    A Phase II Study of MK0457 in Patients With T315I Mutant CML and Ph+All (0457-008)

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