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A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00298987
First received: March 2, 2006
Last updated: February 4, 2010
Last verified: June 2008
History of Changes
  Purpose

The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied.


Condition Intervention Phase
Leukemia, Myeloid, Chronic
Leukemia, Lymphocytic, Acute, L2
 Drug: Dasatinib
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Dasatinib (BMS-354825) in Subjects With Chronic Myelogenous Leukemia With Accelerated or Myeloid or Lymphoid Blast Phase or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant to or Intolerant of Imatinib Mesylate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Provide therapy to patients for which there is no therapeutic alternative

Secondary Outcome Measures:
  • Safety data collection

Estimated Enrollment: 400
Study Start Date: February 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: Dasatinib
Tablets, Oral, 70 mg, Twice daily, 2 months.
Other Name: Sprycel

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of accelerated phase or blast phase CML or Ph+ ALL
  • Intolerant or resistant to imatinib mesylate
  • 18 years of age or older
  • ECOG performance 0-2 (greater than 50% of time out of bed)
  • Adequate liver and kidney function

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • History of significant cardiac disease
  • History of significant bleeding disorder (not CML)
  • Prisoners
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298987

  Show 35 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00298987     History of Changes
Other Study ID Numbers: CA180-033
Study First Received: March 2, 2006
Last Updated: February 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Chronic Myeloid Leukemia Accelerated and Blast Phase
Leukemia, Acute, Philadelphia-Positive

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
 Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib
Dasatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013