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

Multiple Indications Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297139
• Other study ID #: CA180-597
• Status: Completed
• Phase: Phase 2
• Start date: July 31, 2015
• Est. completion date: May 15, 2022

Study information

• Verified date: April 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 15, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

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

Related Conditions & MeSH terms

• Multiple Indications Cancer

Intervention

Drug:
• Dasatinib

Locations

Country	Name	City	State
France	Local Institution	Besancon
Poland	Local Institution	Chorzow
Poland	Local Institution - 0006	Kraków	Malopolskie
Poland	Local Institution	Lodz
Poland	Local Institution - 0003	Warsaw
Poland	Local Institution - 0002	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

France,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Received Dasatinib Treatment	Number of participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.	From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
Primary	Duration of Treatment	Duration of treatment for participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.	From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
Secondary	Number of Participants With Adverse Events	Number of Participants with Adverse Events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.	From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)
Secondary	Number of Participants With Serious Adverse Events	Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.	From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting