Myeloid Leukemia, Chronic, Chronic-Phase Clinical Trial
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
NCT number | NCT00324077 |
Other study ID # | CA180-011 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 1 |
First received | May 9, 2006 |
Last updated | February 16, 2016 |
Start date | August 2006 |
Verified date | April 2011 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Local Institution | Los Angeles | California |
United States | Local Institution | New York | New York |
United States | Local Institution | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients. | |||
Secondary | assess safety and tolerability of dasatinib and imatinib administered in combination throughout study | |||
Secondary | identify dose limiting toxicities | |||
Secondary | characterize plasma pharmacokinetics of dasatinib and imatinib in month 1 | |||
Secondary | measure major molecular response rate | |||
Secondary | measure the major cytogenetic response rate | |||
Secondary | characterize mutations in the BCR-ABL gene | |||
Secondary | evaluate progressive free survival and overall survival |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib
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