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

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ClinicalTrials.gov Identifier: NCT00405054
Recruitment Status : Terminated
First Posted : November 29, 2006
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Leukemia Drug: MK0457 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of MK0457 in Patients With T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Study Start Date : December 2006
Primary Completion Date : June 2009
Study Completion Date : June 2009


Arms and Interventions

Arm Intervention/treatment
1
continuous infusion every 14 days
Drug: MK0457
IV infusion 32 mg/m2/hour; 5-day continuous infusion every 14 days


Outcome Measures

Primary Outcome Measures :
  1. efficacy [ Time Frame: 24 Months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405054


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