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

This study has been withdrawn prior to enrollment.
(Insufficient Enrollment)
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00324077
First received: May 9, 2006
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Myeloid Leukemia, Chronic, Chronic-Phase
Drug: Dasatinib in combination with imatinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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

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

Estimated Enrollment: 76
Study Start Date: August 2006
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324077

Locations
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00324077     History of Changes
Other Study ID Numbers: CA180-011
Study First Received: May 9, 2006
Last Updated: April 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Chronic phase chronic myelogenous leukemia (CML)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Disease Attributes
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 April 14, 2014