MK0457 in Patients With Leukemia (0457-003)

A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00111683

Enrollment

Registered

2005-05-25

Start date

2005-06-30

Completion date

2008-05-31

Last updated

2015-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Myelodysplastic Syndrome[Refractory Anemia with, Excess Blasts-1 or 2 (WHO Classification)], Chronic Myelogenous Leukemia in blast crisis

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.

Interventions

DRUGMK0457

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026