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MK0457 in Patients With Leukemia (0457-003)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00111683
First Posted: May 25, 2005
Last Update Posted: August 25, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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: 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

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 ]

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) ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00111683


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00111683     History of Changes
Other Study ID Numbers: 0457-003
2005_033
First Submitted: May 24, 2005
First Posted: May 25, 2005
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:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
Leukemia, B-Cell
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes
Pathologic Processes