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Rollover Study of BMS-354825 in Patients With CML and Ph+ALL

NCT ID: NCT01030718

Last Updated: 2010-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-06-30

Brief Summary

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To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)

Detailed Description

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Conditions

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Chronic Myelogenous Leukemia Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dasatinib (CML-CP)

CML - Chronic Phase

Group Type EXPERIMENTAL

dasatinib

Intervention Type DRUG

Tablet, Oral, (50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID

dasatinib (CML-AP/BP)

CML - Accelerated Phase and Blast Phase

Group Type EXPERIMENTAL

dasatinib

Intervention Type DRUG

Tablet, Oral, (50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID

dasatinib (Ph+ ALL)

Ph+ Acute Lymphoblastic Leukemia

Group Type EXPERIMENTAL

dasatinib

Intervention Type DRUG

Tablet, Oral, (50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID

Interventions

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dasatinib

Tablet, Oral, (50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID

Intervention Type DRUG

Other Intervention Names

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Sprycel BMS-354825

Eligibility Criteria

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Inclusion Criteria

* Subjects who were eligible and completed the previous Phase I and II study (CA180031/NCT00337454) and for whom the principal investigator has deemed that continuation of study drug is in the best interest of the subject

Exclusion Criteria

* Women who are pregnant or breastfeeding
* Subjects who are eligible and willing to undergo transplantation at pre-study
* Non-hematologic intolerance to Dasatinib (BMS-354825) in the previous Phase I and II study (CA180031/NCT00337454)
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

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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CA180-036

Identifier Type: -

Identifier Source: org_study_id