Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase

NCT ID: NCT00324077

Last Updated: 2016-02-17

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.

Detailed Description

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Conditions

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Myeloid Leukemia, Chronic, Chronic-Phase

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Dasatinib in combination with imatinib

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

Los Angeles, California, United States

Site Status

Local Institution

San Francisco, California, United States

Site Status

Local Institution

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CA180-011

Identifier Type: -

Identifier Source: org_study_id

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