MK0457 in Patients With Leukemia (0457-003)

Phase 1

Completed

• Conditions: Lymphocytic Leukemia, B Cell, Acute; Chronic Myelogenous Leukemia in Blast Crisis; Myelodysplastic Syndromes; Myelogenous Leukemia, Chronic
• Interventions: Drug: MK0457

• Registration Number: NCT00111683
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-05-24
• Study First Submitted QC: 2005-05-24
• Study First Posted: 2005-05-25
• Study Start: 2005-06
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK-0457	MK0457	Participants receive MK-0457 as a continuous intravenous infusion (CIV) at assigned dose and duration

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)	Part 1: up to 5 days, Part 2: up to 24 hours

Secondary Outcome Measures

Name	Time	Method
Hematological response rate to MK-0457 as a 5-day CIV infusion	At the end of each cycle (up to 18 months)