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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00349518
Other study ID # CA180-083
Secondary ID EUDRACTnr: 2006-
Status Withdrawn
Phase Phase 2/Phase 3
First received July 6, 2006
Last updated February 16, 2016
Start date December 2006

Study information

Verified date April 2011
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date January 2007
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Males and females, 18 or older

- CP or AD CML or Ph+ ALL

- Intolerant of resistant to imatinib

- ECOG PS 0-2 (CP CML)

- ECOG PS 0-3 (AD CML and Ph+ ALL)

- Adequate hepatic and renal function

Exclusion Criteria:

- Pregnant or breastfeeding females

- History of significant cardiac disease

- History of significant bleeding disorder (not CML)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dasatinib


Locations

Country Name City State
Hungary Local Institution Budapest
Italy Local Institution Bologna
Italy Local Institution Orbassano (To)
Italy Local Institution Roma
Netherlands Local Institution Nijmegen
Netherlands Local Institution Rotterdam
Poland Local Institution Gdansk
Poland Local Institution Katowice
Poland Local Institution Krakow
Poland Local Instiution Lodz
Poland Local Institution Lublin
Poland Local Institution Warsaw
Russian Federation Local Institution Moscow
Russian Federation Local Institution St.Petersburg
United Kingdom Local Institution Birmingham West Midlands
United Kingdom Local Institution Cambridge Cambridgeshire
United Kingdom Local Institution Glasgow Central
United Kingdom Local Institution Liverpool Merseyside
United Kingdom Local Institution London Greater London
United Kingdom Local Institution Newcastle Tyne And Wear

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Hungary,  Italy,  Netherlands,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of drug-related adverse events.
Secondary Chronic Phase CML: Cytogenetic and Hematologic Response
Secondary Advanced Phase CML and Philadelphia positive ALL: Hematologic Response
Secondary Time to and duration of Cytogenetic and Hematologic Response
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