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

Study Timeline

• Study First Submitted: 2006-11-28
• Study First Submitted QC: 2006-11-28
• Study First Posted: 2006-11-29
• Study Start: 2006-12
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-23
• Last Update Posted: 2015-01-26

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

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.

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