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NCT00298987 Clinical Trial

A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate

Leukemia, Myeloid, Chronic Clinical Trial

Official title:
Study of Dasatinib (BMS-354825) in Subjects With Chronic Myelogenous Leukemia With Accelerated or Myeloid or Lymphoid Blast Phase or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant to or Intolerant of Imatinib Mesylate

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00298987
Other study ID # CA180-033
Secondary ID
Status Completed
Phase Phase 2
First received March 2, 2006
Last updated February 4, 2010
Start date February 2006
Est. completion date June 2007

Study information
Verified date June 2008
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 clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of accelerated phase or blast phase CML or Ph+ ALL

- Intolerant or resistant to imatinib mesylate

- 18 years of age or older

- ECOG performance 0-2 (greater than 50% of time out of bed)

- Adequate liver and kidney function

Exclusion Criteria:

- Pregnant or breastfeeding females

- History of significant cardiac disease

- History of significant bleeding disorder (not CML)

- Prisoners

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Dasatinib
Tablets, Oral, 70 mg, Twice daily, 2 months.

Locations
Country Name City State
Canada Local Institution Edmonton Alberta
Canada Local Institution Hamilton Ontario
Canada Local Institution Montreal Quebec
Canada Local Institution Toronto Ontario
Canada Local Institution Vancouver British Columbia
United States Local Institution Ann Arbor Michigan
United States Local Institution Atlanta Georgia
United States Local Institution Aurora Colorado
United States Local Institution Beach Grove Indiana
United States Local Institution Boston Massachusetts
United States Local Institution Charleston South Carolina
United States Local Institution Chattanooga Tennessee
United States Local Institution Cincinnati Ohio
United States Local Institution Cleveland Ohio
United States Local Institution Colorado Springs Colorado
United States Local Institution Corona California
United States Local Institution Daytona Beach Florida
United States Local Institution Detroit Michigan
United States Local Institution Indianapolis Indiana
United States Local Institution Iowa City Iowa
United States Local Institution Jupiter Florida
United States Local Institution Kansas City Kansas
United States Local Institution Lawrenceville Georgia
United States Local Institution Lawton Oklahoma
United States Local Institution Lexington Kentucky
United States Local Institution Louisville Kentucky
United States Local Institution New York New York
United States Local Institution Portland Oregon
United States Local Institution Providence Rhode Island
United States Local Institution Salina Kansas
United States Local Institution Santa Fe New Mexico
United States Local Institution Sheboygan Wisconsin
United States Local Institution Spokane Washington
United States Local Institution Tulsa Oklahoma
United States Local Institution Waterford Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Provide therapy to patients for which there is no therapeutic alternative
Secondary Safety data collection
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