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MK0457 in Patients With Leukemia (0457-003)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00111683
First received: May 24, 2005
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

This is an open-label trial of an investigational drug to treat relapsed/refractory leukemia.


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: Allocation: Non-Randomized
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:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Safety and tolerability of MK0457 as 5 day infusion measured by duration, grade, and time of onset of toxicity. Plasma pK levels by dose level. [ Time Frame: 30 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy (i.e. hematological response). Measurement: Patients will be assessed for efficacy at the end of each treatment cycle based on hematological response criteria. [ Time Frame: 30 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
1
MK0457
 Drug: MK0457
IV infusion at rising dose levels of 2, 4, 8, 12, 16, 20 and 24 mg/m2/hour; 5-day continuous infusion every 21 days for 30 Months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111683

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00111683     History of Changes
Other Study ID Numbers: 2005_033, MK0457-003
Study First Received: May 24, 2005
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013