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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00324077
• Other study ID #: CA180-011
• Status: Withdrawn
• Phase: Phase 1
• First received: May 9, 2006
• Last updated: February 16, 2016
• Start date: August 2006

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: February 2007
• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase
• Myeloid Leukemia, Chronic, Chronic-Phase

Intervention

Drug:
• Dasatinib in combination with imatinib

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm