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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Leukemia

Treatments: Drug: MK0457

Study type: Interventional

Funder types: Industry

Identifiers

NCT00405054

0457-008

MK0457-008

2006_551

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

1

Other group

Description:

continuous infusion every 14 days

Treatment:

Drug: MK0457