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Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib

Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-004278-40-PL
Enrollment
50
Registered
2015-09-08
Start date
2015-11-09
Completion date
Unknown
Last updated
2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia / Castration-Resistant Prostate Cancer

Interventions

Sponsors

Bristol-Myers Squibb International Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Participated in and completed a previous dasatinib protocol (including but not limited to CA180056, CA180363 or CA180227) and is deemed by the investigator to be deriving benefit from dasatinib as defined by the previous protocol. - Receiving dasatinib at the time of signature of informed consent - Males and Females, ages 18 and older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - All patients previously discontinued from a dasatinib study for any reason - Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy - History of allergy to dasatinib

Design outcomes

Primary

MeasureTime frame
Main Objective: The purpose of this study is to continue to provide dasatinib to patients that are currently participating in another dasatinib trial that is ending and for which there is no other option to provide dasatinib;Secondary Objective: Not applicable;Primary end point(s): Number of subjects who received dasatinib treatment and duration of treatment will be collected;Timepoint(s) of evaluation of this end point: End of Study

Secondary

MeasureTime frame
Secondary end point(s): All SAEs and AEs will be collected;Timepoint(s) of evaluation of this end point: End of Study

Countries

Poland

Contacts

Public ContactEU Start Up Department

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026