Multiple Indications Cancer
Conditions
Brief 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.
Interventions
DRUGDasatinib
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received Dasatinib Treatment | From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months) | 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. |
| Duration of Treatment | From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 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 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. |
| Number of Participants With Serious Adverse Events | 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 (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. |
Countries
France, Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prostate Cancer Continuing treatment for prostate cancer participants who have participated on prior protocol CA180-227 investigating dasatinib. Dasatinib tablet administered once a day by mouth. | 1 |
| Chronic Phase - Chronic Myeloid Leukemia (CP-CML) Continuing treatment for CP- CML participants who have participated on prior protocols CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth. | 16 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative reason by sponsor | 0 | 2 |
| Overall Study | Disease progression | 0 | 1 |
| Overall Study | Maximum clinical benefit | 1 | 0 |
| Overall Study | Other reasons | 0 | 8 |
| Overall Study | Participant request to discontinue study treatment | 0 | 1 |
| Overall Study | Study drug toxicity | 0 | 4 |
Baseline characteristics
| Characteristic | Chronic Phase - Chronic Myeloid Leukemia (CP-CML) | Total | Prostate Cancer |
|---|---|---|---|
| Age, Continuous | 64.5 Years | 62 Years | 58 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 15 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 16 Participants | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 1 / 16 |
| other Total, other adverse events | 1 / 1 | 15 / 16 |
| serious Total, serious adverse events | 0 / 1 | 8 / 16 |
Outcome results
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.
Time frame: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
Population: All treated participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prostate Cancer | Duration of Treatment | 25.3 Months |
| Chronic Phase - Chronic Myeloid Leukemia (CP-CML) | Duration of Treatment | 55.9 Months |
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.
Time frame: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prostate Cancer | Number of Participants Who Received Dasatinib Treatment | 1 Participants |
| Chronic Phase - Chronic Myeloid Leukemia (CP-CML) | Number of Participants Who Received Dasatinib Treatment | 16 Participants |
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.
Time frame: From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prostate Cancer | Number of Participants With Adverse Events | 1 Participants |
| Chronic Phase - Chronic Myeloid Leukemia (CP-CML) | Number of Participants With Adverse Events | 15 Participants |
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.
Time frame: From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prostate Cancer | Number of Participants With Serious Adverse Events | 0 Participants |
| Chronic Phase - Chronic Myeloid Leukemia (CP-CML) | Number of Participants With Serious Adverse Events | 8 Participants |