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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dasatinib

Group Type EXPERIMENTAL

dasatinib

Intervention Type DRUG

100mg QD

Interventions

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dasatinib

100mg QD

Intervention Type DRUG

Other Intervention Names

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BMS-354825

Eligibility Criteria

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Inclusion Criteria

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

1. ECOG performance status (PS) score 0-2
2. Adequate hepatic function
3. Adequate renal function
4. 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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No