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Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase

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: NCT00324077
Recruitment Status : Withdrawn (Insufficient Enrollment)
First Posted : May 10, 2006
Last Update Posted : February 17, 2016
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.

Condition or disease Intervention/treatment Phase
Myeloid Leukemia, Chronic, Chronic-Phase Drug: Dasatinib in combination with imatinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of the Combination of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
Study Start Date : August 2006
Actual Primary Completion Date : February 2007

Primary Outcome Measures :
  1. To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.

Secondary Outcome Measures :
  1. assess safety and tolerability of dasatinib and imatinib administered in combination throughout study
  2. identify dose limiting toxicities
  3. characterize plasma pharmacokinetics of dasatinib and imatinib in month 1
  4. measure major molecular response rate
  5. measure the major cytogenetic response rate
  6. characterize mutations in the BCR-ABL gene
  7. evaluate progressive free survival and overall survival

Information from the National Library of Medicine

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

Inclusion Criteria:

  • males and females, 18 or older
  • chronic phase Ph+ or BCR-ABL positive CML
  • current complete hematologic response to imatinib
  • lack of major molecular response
  • on imatinib for at least one year
  • on the same imatinib dose for at least 6 months
  • adequate hepatic and renal function

Exclusion Criteria:

  • History of accelerated or blast phase CML
  • Serious uncontrolled medical disorder or active infection
  • Significant cardiovascular disease or bleeding disorder
  • Concurrent use of medications at risk of causing Torsades de Pointe

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): NCT00324077

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United States, California
Local Institution
Los Angeles, California, United States
Local Institution
San Francisco, California, United States
United States, New York
Local Institution
New York, New York, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Layout table for additonal information Identifier: NCT00324077    
Other Study ID Numbers: CA180-011
First Posted: May 10, 2006    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: April 2011
Keywords provided by Bristol-Myers Squibb:
Chronic phase chronic myelogenous leukemia (CML)
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action