Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00349518

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia Acute Lymphoblastic Leukemia	Drug: Dasatinib	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

Incidence and severity of drug-related adverse events. []

Secondary Outcome Measures

Chronic Phase CML: Cytogenetic and Hematologic Response []
Advanced Phase CML and Philadelphia positive ALL: Hematologic Response []
Time to and duration of Cytogenetic and Hematologic Response []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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)

Contacts and Locations

Locations

	Site	City	State	Country
1	Local Institution	Budapest		Hungary
2	Local Institution	Bologna		Italy
3	Local Institution	Orbassano (To)		Italy
4	Local Institution	Roma		Italy
5	Local Institution	Nijmegen		Netherlands
6	Local Institution	Rotterdam		Netherlands
7	Local Institution	Gdansk		Poland
8	Local Institution	Katowice		Poland
9	Local Institution	Krakow		Poland
10	Local Instiution	Lodz		Poland
11	Local Institution	Lublin		Poland
12	Local Institution	Warsaw		Poland
13	Local Institution	Moscow		Russian Federation
14	Local Institution	St.Petersburg		Russian Federation
15	Local Institution	Cambridge	Cambridgeshire	United Kingdom
16	Local Institution	Glasgow	Central	United Kingdom
17	Local Institution	London	Greater London	United Kingdom
18	Local Institution	Liverpool	Merseyside	United Kingdom
19	Local Institution	Newcastle	Tyne And Wear	United Kingdom
20	Local Institution	Birmingham	West Midlands	United Kingdom