MK0457 in Patients With Leukemia (0457-003)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 24, 2005
Last updated: August 21, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Chronic Myelogenous Leukemia in Blast Crisis
Lymphocytic Leukemia, B Cell, Acute
Myelodysplastic Syndromes
Myelogenous Leukemia, Chronic
Drug: MK0457
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [ Time Frame: Part 1: up to 5 days, Part 2: up to 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hematological response rate to MK-0457 as a 5-day CIV infusion [ Time Frame: At the end of each cycle (up to 18 months) ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: June 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-0457
Participants receive MK-0457 as a continuous intravenous infusion (CIV) at assigned dose and duration
Drug: MK0457


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00111683

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00111683     History of Changes
Other Study ID Numbers: 0457-003, 2005_033
Study First Received: May 24, 2005
Last Updated: August 21, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Myelodysplastic Syndrome[Refractory Anemia with
Excess Blasts-1 or 2 (WHO Classification)]
Chronic Myelogenous Leukemia in blast crisis

Additional relevant MeSH terms:
Blast Crisis
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Myelodysplastic Syndromes
Bone Marrow Diseases
Cell Transformation, Neoplastic
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Precancerous Conditions processed this record on November 25, 2015