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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Indications Cancer

Intervention / Treatment
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* Drug: Dasatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dasatinib<br>This is a continuation roll-over study for patients receiving benefit from prior dasatinib protocols. All subjects will receive dasatinib as per previous protocol | Drug: Dasatinib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) |