Back to resultsPhase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
Primary Purpose
Myeloid Leukemia, Chronic, Chronic-Phase
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dasatinib in combination with imatinib
Sponsored by
About this trial
This is an interventional treatment trial for Myeloid Leukemia, Chronic, Chronic-Phase focused on measuring Chronic phase chronic myelogenous leukemia (CML)
Eligibility 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
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00324077
Brief Title
Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient Enrollment
Study Start Date
August 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloid Leukemia, Chronic, Chronic-Phase
Keywords
Chronic phase chronic myelogenous leukemia (CML)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dasatinib in combination with imatinib
Primary Outcome Measure Information:
Title
To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.
Secondary Outcome Measure Information:
Title
assess safety and tolerability of dasatinib and imatinib administered in combination throughout study
Title
identify dose limiting toxicities
Title
characterize plasma pharmacokinetics of dasatinib and imatinib in month 1
Title
measure major molecular response rate
Title
measure the major cytogenetic response rate
Title
characterize mutations in the BCR-ABL gene
Title
evaluate progressive free survival and overall survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Facility Information:
Facility Name
Local Institution
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Francisco
State/Province
California
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
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