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A Phase I Dose Escalation Study of the Combination of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase


Phase 1
18 Years
N/A
Not Enrolling
Both
Myeloid Leukemia, Chronic, Chronic-Phase

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Trial Information

A Phase I Dose Escalation Study of the Combination of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Authority:

United States: Food and Drug Administration

Study ID:

CA180-011

NCT ID:

NCT00324077

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Myeloid Leukemia, Chronic, Chronic-Phase
  • Chronic phase chronic myelogenous leukemia (CML)
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase
  • Chronic Disease

Name

Location
Local Institution Bronx, New York  
Local Institution Corona, California