Trial | NCT00866736  Report issue

Title

A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    dasatinib ...

  • Study Participants

    65
The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.
Study Started
Mar 31
2009
Primary Completion
Jun 30
2012
Study Completion
Jun 30
2012
Last Update
Sep 15
2015
Estimate

Drug dasatinib

100mg QD

  • Other names: BMS-354825

dasatinib Experimental

Criteria 

Inclusion Criteria:

Signed Written Informed Consent
Subjects with chronic phase chronic myeloid leukemia (CML)
Subjects resistant/intolerant to imatinib

Subjects presenting:

ECOG performance status (PS) score 0-2
Adequate hepatic function
Adequate renal function
Adequate lung function

Exclusion Criteria:

Concurrent malignancy other than CML
Women who are pregnant or breastfeeding
Concurrent pleural effusion
Uncontrolled or significant cardiovascular disease
A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
Prior therapy with dasatinib
Subjects with T315I and/or F317L BCR-ABL point mutations
No Results Posted