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A Randomized, Multicenter, Open-label Phase II Study of Dasatinib (BMS-354825) Administered Orally at a Dose of 50mg Twice Daily or 100mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Imatinib


Phase 1/Phase 2
20 Years
75 Years
Not Enrolling
Both
Myeloid Leukemia, Chronic

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Trial Information

A Randomized, Multicenter, Open-label Phase II Study of Dasatinib (BMS-354825) Administered Orally at a Dose of 50mg Twice Daily or 100mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Imatinib


Inclusion Criteria:



- Philadelphia chromosome positive or bcr-abl gene positive Chronic phase Chronic
Myelogenous Leukemia (CML) subjects must have primary or acquired resistance to
Imatinib mesylate or have intolerance of imatinib mesylate

- Performance status (general conditions) specified by the Eastern Cooperative Oncology
Group: 0-2

- Men and women, ages 20 to 75

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 3 months after
the study in such a manner that the risk of pregnancy is minimized

Exclusion Criteria:

- Subjects who are eligible and willing to undergo transplantation at pre-study

- Women who are pregnant or breastfeeding

- Uncontrolled or significant cardiovascular disease

- History of significant bleeding disorder unrelated to CML

- Adequate hepatic function

- Adequate renal function

- Medication that increases bleeding risk

- Medication that changes heart rhythms

- Subjects who are compulsory detained for legal reasons or treatment of either a
psychiatric or physical (e.g., infectious disease) illness must not be enrolled into
this study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24

Outcome Description:

Cytogenetic responses (CyR) are based on the percentage of Philadelphia-positive (Ph+) metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), and Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).

Outcome Time Frame:

Week 24

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

CA180-138

NCT ID:

NCT00482703

Start Date:

May 2007

Completion Date:

May 2009

Related Keywords:

  • Myeloid Leukemia, Chronic
  • Imatinib resistant or intolerant chronic phase CML
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome
  • Chronic Disease

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