MK0457 in Patients With Leukemia (0457-003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00111683
Recruitment Status : Completed
First Posted : May 25, 2005
Last Update Posted : August 25, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia
Study Start Date : June 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
Experimental: MK-0457
Participants receive MK-0457 as a continuous intravenous infusion (CIV) at assigned dose and duration
Drug: MK0457

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

Secondary Outcome Measures :
  1. Hematological response rate to MK-0457 as a 5-day CIV infusion [ Time Frame: At the end of each cycle (up to 18 months) ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00111683

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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00111683     History of Changes
Other Study ID Numbers: 0457-003
First Posted: May 25, 2005    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015

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:
Myelodysplastic Syndromes
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
Leukemia, B-Cell
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Cell Transformation, Neoplastic
Neoplastic Processes
Pathologic Processes