A Phase II Study of MK0457 in Patients With T315I Mutant CML and Ph+All (0457-008)
Phase 2
Terminated
- Conditions
- Leukemia
- Interventions
- Drug: MK0457
- Registration Number
- NCT00405054
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 52
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
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 MK0457 continuous infusion every 14 days
- Primary Outcome Measures
Name Time Method efficacy 24 Months
- Secondary Outcome Measures
Name Time Method