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NCT Number: NCT00111683

MK0457 in Patients With Leukemia (0457-003)

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.

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Key information

Conditions

Chronic Myelogenous Leukemia in Blast Crisis Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Lymphatic Diseases Lymphocytic Leukemia, B Cell, Acute Lymphoproliferative Disorders Myelodysplastic Syndromes Myelogenous Leukemia, Chronic Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0457

Drug

Primary outcomes

  1. Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

    Time frame: Part 1: up to 5 days, Part 2: up to 24 hours

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
May 25, 2005
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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