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A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

NCT ID: NCT00482703

Last Updated: 2010-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-05-31

Brief Summary

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The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid leukemia (CML) once daily (QD) or twice daily. (BID)

Detailed Description

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Conditions

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Myeloid Leukemia, Chronic

Keywords

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Imatinib resistant or intolerant chronic phase CML

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

tablets, Oral, 100 mg, once daily

B

Group Type EXPERIMENTAL

dasatinib

Intervention Type DRUG

tablets, Oral, 50 mg, twice daily

Interventions

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Dasatinib

tablets, Oral, 100 mg, once daily

Intervention Type DRUG

dasatinib

tablets, Oral, 50 mg, twice daily

Intervention Type DRUG

Other Intervention Names

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Sprycel BMS-354825 Sprycel BMS-354825

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Nagoya, Aichi-ken, Japan

Site Status

Local Institution

Nishinomiya-Shi, Hyōgo, Japan

Site Status

Local Institution

Kagoshima, Kagoshima-ken, Japan

Site Status

Local Institution

Isehara-Shi, Kanagawa, Japan

Site Status

Local Institution

Kyoto, Kyoto, Japan

Site Status

Local Institution

Hamamatsu, Shizuoka, Japan

Site Status

Local Institution

Bunkyo-Ku, Tokyo, Japan

Site Status

Local Institution

Chuo-Ku, Tokyo, Japan

Site Status

Local Institution

Shibuya-Ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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CA180-138

Identifier Type: -

Identifier Source: org_study_id