MK0457 in Patients With Leukemia (0457-003)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Chronic Myelogenous Leukemia in Blast Crisis; Lymphocytic Leukemia, B Cell, Acute; Myelogenous Leukemia, Chronic; Myelodysplastic Syndromes

Treatments: Drug: MK0457

Study type: Interventional

Funder types: Industry

Identifiers

NCT00111683

0457-003

2005_033

Details and patient eligibility

About

In this study participants with relapsed/refractory leukemia will be given MK-0457 in sequential cohorts and with varying treatment duration to determine the maximum tolerated dose (MTD) for MK-0457.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Part 1:

• Patients with relapsed/refractory acute myelogenous leukemia (AML), poor risk myelodysplastic syndrome (MDS), B-cell acute lymphocytic leukemia (ALL), myeloproliferative diseases, or chronic myelogenous leukemia (CML) in blast crisis

Part 2:

• Acute myelogenous leukemia (with FLT-3 mutation ), and myeloproliferative diseases only
• At least 2 weeks since the last cytotoxic therapy
• Acceptable renal and hepatic function
• Ambulatory, capable of all self-care, and out of bed for more than 50% of waking hours
• More than 2 months since autologous bone marrow or peripheral blood stem cell transplantation

Exclusion criteria

• Not fully recovered from previous anti-leukemia therapy
• Previous allogeneic bone marrow transplant
• Uncontrolled congestive heart failure
• Myocardial infarction within the last 3 months
• Active or uncontrolled infection
• Pregnancy or lactation
• Currently active second malignancy, other than non-melanoma skin cancer
• History of hepatitis B or C, known HIV positivity, or AIDS related illness

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

MK-0457

Experimental group

Description:

Participants receive MK-0457 as a continuous intravenous infusion (CIV) at assigned dose and duration

Treatment:

Drug: MK0457