Trial Outcomes & Findings for Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer (NCT NCT00385580)

Results Overview

Response = confirmed PSA response (decrease in PSA =\>50% from baseline), confirmed improved bone scan (disappearance of =\> 1 lesion, no new lesions, new pain not developing), confirmed CR (disappearance of all lesions) or confirmed PR (=\>30% in sum of LD of all lesions compared to baseline sum LD), SD (neither sufficient increase for PD \[=\>20% increase in sum of LD of all target lesions\] nor sufficient shrinkage for PR), based on RECIST.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

94 participants

Primary outcome timeframe

Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.

Results posted on

2013-04-30

Participant Flow

130 participants were enrolled in the study; 95 participants entered the treatment period. 67 discontinued due to disease progression, 13 for study drug toxicity, 5 for other reasons, 4 withdrew consent, 2 for adverse events unrelated to the study, 2 requested discontinuation, 1 due to death, and 1 due to maximum clinical benefit.

Participant milestones

Participant milestones
Measure	Dasatinib 100 mg Once Daily (QD) Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Overall Study STARTED	48	47
Overall Study COMPLETED	48	47
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Total n=95 Participants Total of all reporting groups
Age Continuous	68.0 years n=5 Participants	70.0 years n=7 Participants	69.0 years n=5 Participants
Age, Customized < 65 years	12 participants n=5 Participants	13 participants n=7 Participants	25 participants n=5 Participants
Age, Customized >=65 years	36 participants n=5 Participants	34 participants n=7 Participants	70 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized White	46 participants n=5 Participants	45 participants n=7 Participants	91 participants n=5 Participants
Race/Ethnicity, Customized Black/African American	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 0=normal activity	35 participants n=5 Participants	28 participants n=7 Participants	63 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 1=symptoms, but fully ambulatory	13 participants n=5 Participants	18 participants n=7 Participants	31 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2=symptomatic, but in bed < 50% of the day.	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 3=needs to be in bed >50% of day, not bedridden	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 4=unable to get out of bed	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 5=dead	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Height continuous	174.44 centimeter (cm) STANDARD_DEVIATION 7.35 • n=5 Participants	172.63 centimeter (cm) STANDARD_DEVIATION 12.67 • n=7 Participants	173.58 centimeter (cm) STANDARD_DEVIATION 10.19 • n=5 Participants
Weight continuous	92.50 kilogram (Kg) STANDARD_DEVIATION 18.25 • n=5 Participants	89.16 kilogram (Kg) STANDARD_DEVIATION 14.72 • n=7 Participants	90.85 kilogram (Kg) STANDARD_DEVIATION 16.60 • n=5 Participants
FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline Total Score	26.00 Units on a scale n=5 Participants	26.00 Units on a scale n=7 Participants	26.00 Units on a scale n=5 Participants
FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline GP1	3.00 Units on a scale n=5 Participants	3.00 Units on a scale n=7 Participants	3.00 Units on a scale n=5 Participants
FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline GP4	3.00 Units on a scale n=5 Participants	3.00 Units on a scale n=7 Participants	3.00 Units on a scale n=5 Participants
FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline GE6	3.00 Units on a scale n=5 Participants	2.00 Units on a scale n=7 Participants	2.00 Units on a scale n=5 Participants
FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline C2	4.00 Units on a scale n=5 Participants	4.00 Units on a scale n=7 Participants	4.00 Units on a scale n=5 Participants
FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline P2	3.00 Units on a scale n=5 Participants	3.00 Units on a scale n=7 Participants	3.00 Units on a scale n=5 Participants
FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline P3	4.00 Units on a scale n=5 Participants	4.00 Units on a scale n=7 Participants	4.00 Units on a scale n=5 Participants
FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline P7	4.00 Units on a scale n=5 Participants	4.00 Units on a scale n=7 Participants	4.00 Units on a scale n=5 Participants
FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline P8	4.00 Units on a scale n=5 Participants	4.00 Units on a scale n=7 Participants	4.00 Units on a scale n=5 Participants
Urinary N-telopeptide (uNTx)Value from Baseline < 60 nanomol (nmol)/mmol creatinine	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Urinary N-telopeptide (uNTx)Value from Baseline >= 60 nmol/mmol creatinine	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Urinary N-telopeptide (uNTx)Value from Baseline Unknown uNTx value	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Bone-specific Alkaline Phosphatase (BAP) Value from baseline High >41.3 U/L	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Bone-specific Alkaline Phosphatase (BAP) Value from baseline Low <15 U/L	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Bone-specific Alkaline Phosphatase (BAP) Value from baseline Normal 15-41.3 U/L	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Bone-specific Alkaline Phosphatase (BAP) Value from baseline Unknown	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.

Population: All treated participants.

Response = confirmed prostate specific antigen (PSA) response (decrease in PSA =\>50% from baseline), confirmed improved bone scan (disappearance of =\> 1 lesion, no new lesions, new pain not developing), confirmed complete response (CR: disappearance of all lesions) or confirmed partial response (PR: =\>30% in sum of longest diameter \[LD\] of all lesions compared to baseline sum LD), stable disease (SD: neither sufficient increase for progressive disease \[PD: =\>20% increase in sum of LD of all target lesions\] nor sufficient shrinkage for PR), based on Response Criteria in Solid Tumors \[RECIST\].

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With a Response	12 participants	13 participants	—

PRIMARY outcome

Timeframe: Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.

Population: All treated participants.

Response = confirmed PSA response (decrease in PSA =\>50% from baseline), confirmed improved bone scan (disappearance of =\> 1 lesion, no new lesions, new pain not developing), confirmed CR (disappearance of all lesions) or confirmed PR (=\>30% in sum of LD of all lesions compared to baseline sum LD), SD (neither sufficient increase for PD \[=\>20% increase in sum of LD of all target lesions\] nor sufficient shrinkage for PR), based on RECIST.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Percentage of Participants With a Response	25.00 Percentage of Participants Interval 13.64 to 39.6	27.70 Percentage of Participants Interval 15.62 to 42.64	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements.

PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline, for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=43 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=43 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With a Decrease in PSA by at Least 50% From Baseline	1 participants	1 participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements.

PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=43 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=43 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline	2.3 Percentage of Participants	2.3 Percentage of Participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: Participants with a decrease in PSA by at least 50% from baseline

PSA is a marker of prostate cancer. The duration of PSA response is measured from the time that the first of the 2 consecutive measurements met the criteria for confirmed PSA response, until the date of the first of the 3 consecutive measurements that confirm PSA progression, or the date of disease progression, or the date of death.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=1 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=1 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Months of Decrease in PSA by at Least 50% From Baseline	0.82 months	11.17 months	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements.

PSA is a marker of prostate cancer. PSA velocity measures the rate of change of PSA values. A decrease in PSA values and hence PSA velocity is an early indicator of potential anti-tumor activity.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=43 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=43 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With Decrease in PSA Velocity	25 participants Interval -0.4 to 5.7	16 participants Interval -0.2 to 13.2	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements.

PSA is a marker of prostate cancer. A decrease in PSA value is an early indicator of potential anti-tumor activity. Log (PSA) is assumed to have a linear relationship with time. The PSA log slope is defined as the slope of the log PSA line.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=43 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=43 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With Decrease in PSA Log Slope	38 participants Interval -0.015 to 0.018	34 participants Interval -0.008 to 0.029	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements and positive log slope pre-treatment and on-study measurements.

PSA is a marker of prostate cancer. PSA doubling time is defined as log 2 divided by the slope of the log PSA line. An increase in PSA doubling time indicates improvement in anti-tumor activity.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=38 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=41 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With Increase in PSA Doubling Time	34 participants Interval 39.0 to 858.0	32 participants Interval 24.0 to 2622.0	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Population: All response-evaluable participants.

Tumor response was defined as the number of participants whose best response was CR or PR, per RECIST: CR: disappearance of all target/non-target lesions; PR: \>= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=18 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=21 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With CR or PR	1 participants	0 participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Population: All response-evaluable participants.

Disease control rate is defined as the number of participants whose best response was CR, PR or SD, per RECIST: CR: disappearance of all target/non-target lesions; PR: \>= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD; SD: neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR; PD: defined as appearance of new lesion/s, or \>=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=18 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=21 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With CR, PR or SD	11 participants	12 participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Population: All response-evaluable participants.

An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=40 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=38 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With a Confirmed Improved Bone Scan	0 participants	1 participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Population: Participants with confirmed improved bone scan.

An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=40 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=38 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Percentage of Participants With Confirmed Improved Bone Scan	0.0 Percentage of Participants	2.6 Percentage of Participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.

Population: All treated participants.

Disease progression: progression of target lesions or unequivocal progression of non-measurable lesions/disease as evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI), not as evaluated by bone scan (non-measurable lesions included visceral and bone lesions), loss of PSA response (only for participants who achieved a PSA response) or Investigator-defined clinical progression based on physical examination, history, symptoms, and ECOG-PS. For participants who did not progress or die, date of last PSA measurement or tumor assessment was used, whichever occurred first.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With Disease Progression	30 participants	34 participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.

Population: All treated participants.

Measured from date of first dose to date of first 3 consecutive measurements that confirm PSA progression, date of disease progression,or death date.Disease progression:progression of target lesions or unequivocal progression of non-measurable lesions/disease as evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI),loss of PSA response or Investigator-defined clinical progression based on physical examination,history,symptoms,and ECOG-PS.For participants who did not progress or die,date of last PSA measurement or tumor assessment was used, whichever occurred first.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Median Number of Months to Disease Progression	4.7 months Interval 2.8 to 5.5	2.8 months Interval 2.8 to 5.4	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Population: All treated participants.

FAPSI-8:symptom index of important clinician-rated symptoms/concerns to monitor when assessing value of treatment for advanced prostate cancer. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). GP1:I have lack of energy, GP4:I have pain, GE6:I worry that my condition will get worse, C2: I am losing weight, P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do, P7:I have difficulty urinating, P8:My problems with urinating limit my activities.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Median Change From Baseline in Individual FAPSI Scores at Week 12 GE6	0.00 Units on a scale Interval -3.0 to 2.0	0.00 Units on a scale Interval -2.0 to 3.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 12 GP1	0.00 Units on a scale Interval -2.0 to 2.0	-1.00 Units on a scale Interval -4.0 to 3.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 12 GP4	0.00 Units on a scale Interval -2.0 to 2.0	0.00 Units on a scale Interval -2.0 to 2.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 12 C2	0.00 Units on a scale Interval -3.0 to 3.0	0.00 Units on a scale Interval -3.0 to 1.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 12 P2	0.00 Units on a scale Interval -3.0 to 1.0	0.00 Units on a scale Interval -2.0 to 2.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 12 P3	0.00 Units on a scale Interval -1.0 to 2.0	0.00 Units on a scale Interval -3.0 to 3.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 12 P7	0.00 Units on a scale Interval -4.0 to 2.0	0.00 Units on a scale Interval -3.0 to 2.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 12 P8	0.00 Units on a scale Interval -1.0 to 1.0	0.00 Units on a scale Interval -3.0 to 2.0	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Population: All treated participants.

The FAPSI-8 is a symptom index comprised of the most important clinician-rated symptoms or concerns to monitor when assessing the value of treatment for advanced prostate cancer. It includes 8 items developed to measure symptoms/concerns specific to prostate cancer such as fatigue, pain (3-items), weight loss, difficulty with urination (2-items) and concerns about the condition becoming worse. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much).

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 Week 12 (n=26, 29)	0.00 Units on a scale Interval -11.0 to 4.0	-2.00 Units on a scale Interval -12.0 to 6.0	—
Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 Week 24 (n=14, 6)	-2.50 Units on a scale Interval -8.0 to 1.0	-2.00 Units on a scale Interval -11.0 to 4.0	—
Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 Week 36 (n=4, 5)	NA Units on a scale Week 36 data was not summarized in the CSR because of the small N, and it was agreed that the summaries based on small N were not interpretable.	NA Units on a scale Week 36 data was not summarized in the CSR because of the small N, and it was agreed that the summaries based on small N were not interpretable.	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Population: All treated participants.

FAPSI-8:symptom index of important clinician-rated symptoms/concerns to monitor when assessing value of treatment for advanced prostate cancer. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). GP1:I have lack of energy, GP4:I have pain, GE6:I worry that my condition will get worse, C2: I am losing weight, P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do, P7:I have difficulty urinating, P8:My problems with urinating limit my activities.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Median Change From Baseline in Individual FAPSI Scores at Week 24 GP1	0.00 Units on a scale Interval -2.0 to 1.0	0.00 Units on a scale Interval -2.0 to 0.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 24 GP4	-0.50 Units on a scale Interval -3.0 to 0.0	-0.50 Units on a scale Interval -1.0 to 2.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 24 GE6	-0.50 Units on a scale Interval -2.0 to 2.0	-0.50 Units on a scale Interval -1.0 to 1.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 24 C2	0.00 Units on a scale Interval -2.0 to 3.0	-0.50 Units on a scale Interval -2.0 to 0.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 24 P2	0.00 Units on a scale Interval -2.0 to 1.0	0.00 Units on a scale Interval -3.0 to 1.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 24 P3	0.00 Units on a scale Interval -1.0 to 1.0	0.00 Units on a scale Interval -4.0 to 1.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 24 P7	0.00 Units on a scale Interval -2.0 to 1.0	0.00 Units on a scale Interval -1.0 to 0.0	—
Median Change From Baseline in Individual FAPSI Scores at Week 24 P8	0.00 Units on a scale Interval -2.0 to 1.0	0.00 Units on a scale Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Population: All treated participants. The number of participants for whom this data are available is too small for analysis.

FAPSI-8:index of symptoms/concerns when assessing value of treatment for advanced prostate cancer.Participants respond to each item on 5-point Likert-type scale:0 (not at all) to 4 (very much).GP1:I have lack of energy,GP4:I have pain,GE6:I worry that my condition will get worse,C2:I am losing weight,P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do,P7:I have difficulty urinating,P8:My problems with urinating limit my activities. The number of participants for whom these data are available is too small for analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study drug therapy up to 30 days after the last dose.

Population: All treated participants.

AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs Deaths	2 participants	2 participants	—
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs AEs	48 participants	47 participants	—
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs SAEs	10 participants	11 participants	—
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs All AEs Leading to Discontinuation	13 participants	8 participants	—

SECONDARY outcome

Timeframe: From start of study drug therapy up to 30 days after the last dose.

Population: All treated participants.

Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy. Drug-related AEs were graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0: Grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death. Participants who discontinued the study due to any drug-related AEs were also recorded.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. Drug-related SAEs	1 participants	6 participants	—
Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. Drug-related AEs	43 participants	47 participants	—
Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. Drug-related Grade 3-4 AEs	7 participants	15 participants	—
Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. Drug-related AEs Leading to Discontinuation	9 participants	7 participants	—

SECONDARY outcome

Timeframe: Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.

Population: All treated participants.

Abnormalities were graded per the NCI CTC, version 3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Hemoglobin: Grade 3:6.5 - \<8.0g/dL, Grade 4: \<6.5g/dL. Platelets: Grade 3: 25.0 - \<50.0\*10\^9/L, Grade 4: \<25.0\*10. Absolute Neutrophil Count (ANC): Grade 3: 0.5 - \<1.0\*10\^9/L, Grade 4: \<0.5\*10\^9/L. Leukocytes: Grade 3: 1.0 - \<2.0\*10\^9/L, Grade 4: \<1.0\*10\^9/L.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With Grade 3-4 Hematology Abnormalities Absolute Neutrophil Count (ANC)	0 participants	1 participants	—
Number of Participants With Grade 3-4 Hematology Abnormalities Hemoglobin	0 participants	1 participants	—
Number of Participants With Grade 3-4 Hematology Abnormalities Platelet Count	0 participants	1 participants	—
Number of Participants With Grade 3-4 Hematology Abnormalities Leukocytes	0 participants	0 participants	—

SECONDARY outcome

Timeframe: Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.

Population: All treated participants.

Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase: Grade 3: 5.0-20.0 \* ULN (upper limit of normal), Grade 4: \>20.0 \* ULN; calcium: Grade 3: 6.0-\<7.0 or \>12.5-13.5 mg/dL, Grade 4: \<0.6-\>13.5 mg/dL; bilirubin: Grade 3: \>3-10 \* ULN, Grade 4: \>10 \* ULN.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium Alanine Aminotransferase	0 participants	0 participants	—
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium Aspartate Aminotransferase	0 participants	0 participants	—
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium Alkaline Phosphatase	6 participants	0 participants	—
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium Bilirubin	0 participants	0 participants	—
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium Hypercalcemia	0 participants	0 participants	—
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium Hypocalcemia	1 participants	0 participants	—

SECONDARY outcome

Timeframe: Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.

Population: All treated participants.

Abnormalities were graded per the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: phosphorous: Grade 3: 1.0-\<2.0 mg/dL, Grade 4: \<1.0 mg/dL; sodium: Grade 3: 120-\<130 or \>155-160mEq/L, Grade 4: \<120 or \>160 mEq/L; creatinine: Grade 3: \>3.0-6.0 \* ULN, Grade 4: \>6.0 \* ULN; potassium: Grade 3: 2.5 -\<3.0 or \>6.0 -7.0 mEq/L, Grade 4: \< 2.5 or \>7.0 mEq/L.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous Creatinine	0 participants	0 participants	—
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous Hyperkalemia	0 participants	0 participants	—
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous Hypokalemia	2 participants	1 participants	—
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous Hypernatremia	0 participants	0 participants	—
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous Hyponatremia	1 participants	1 participants	—
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous Phosphorus, Inorganic	2 participants	2 participants	—

SECONDARY outcome

Timeframe: Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12, every 4 weeks thereafter and at the end of the treatment.

Population: All treated participants.

LDH is a laboratory safety parameter. Normal ranges for LD vary with both age and disease status, and another reason for variation in upper limit of normal (ULN) and lower limit of normal (LLN) is that LD was measured via a local (versus a standardized) laboratory. It is therefore not possible to provide one ULN and LLN for the population.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With Abnormal Lactate Dehydrogenase (LD)	33 participants	41 participants	—

SECONDARY outcome

Timeframe: Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.

Population: All treated participants.

Participants' urine samples were tested for the presence of blood, glucose and protein. If these substances were present in a participant's urine, the results were given as "positive".

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With Positive Urinalysis Blood	20 participants	21 participants	—
Number of Participants With Positive Urinalysis Glucose	2 participants	1 participants	—
Number of Participants With Positive Urinalysis Protein	21 participants	26 participants	—

SECONDARY outcome

Timeframe: From start of study drug therapy up to 30 days after the last dose.

Population: All treated participants.

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heart rate. A prolonged QT interval is a risk factor for ventricular tachyarrhythmias and sudden death.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=47 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With QTc Prolongation	3 participants	10 participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: All treated participants who had a baseline uNTx value \<=ULN and at least 1 on-study value.

uNTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=26 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=26 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx 0-35 percent decrease	2 participants	6 participants	—
Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx >35-70 percent decrease	13 participants	12 participants	—
Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx >70 percent decrease	5 participants	1 participants	—
Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx No change or increase	6 participants	7 participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: All treated participants who had a baseline uNTx value \>ULN and at least 1 on-study value.

uNTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=17 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=15 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx 0-35 percent decrease	6 participants	4 participants	—
Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx >35-70 percent decrease	3 participants	9 participants	—
Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx >70 percent decrease	4 participants	1 participants	—
Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx No change or increase	4 participants	1 participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: Participants with a baseline uNTx value \> ULN and at least 1 on-study value.

uNTx is a measure of bone metabolism. uNTx response is defined for participants with baseline uNTx above ULN. It is defined as either on-study uNTx values decreasing to within normal limits or 35% or more decrease in uNTx from baseline, whichever happens first.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=17 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=15 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With a uNTx Response	10 participants	10 participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: Participants who demonstrated a uNTx response.

uNTx is a measure of bone metabolism.The median number of months of uNTx response was calculated for participants with baseline uNTx =\< ULN and uNTx progression during treatment, from first dose of dasatinib to uNTx progression.For participant with baseline uNTx above ULN, it was time from uNTx response to uNTx progression.For participants with baseline uNTx equal to or below ULN or uNTx response and no uNTx progression, the date of last uNTx assessment was used. Duration of uNTx response was not defined for participants with baseline value greater than ULN who never achieved uNTx responses.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=10 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=10 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Median Number of Months of uNTx Response	NA months Interval 6.3 to Not enough participants with response had progressed; therefore, median and upper limit of 95% confidence interval could not be estimated.	NA months Interval 4.7 to Not enough participants with response had progressed; therefore, median and upper limit of 95% confidence interval could not be estimated.	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: All treated participants who had a baseline BAP value \<=ULN and at least 1 on-study value.

BAP is a measure of bone metabolism. A decrease in BAP relative to the baseline indicates decrease in bone metabolism.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=28 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=23 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP 0-35 percent decrease	12 participants	14 participants	—
Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP >35-70 percent decrease	5 participants	2 participants	—
Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP >70 percent decrease	1 participants	0 participants	—
Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP No change or increase	10 participants	7 participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: All treated participants who had a baseline BAP value \>ULN and at least 1 on-study value.

BAP is a measure of bone metabolism. A decrease in BAP relative to baseline indicates a decrease in bone metabolism.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=16 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=17 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP 0-35 percent decrease	6 participants	6 participants	—
Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP >35-70 percent decrease	1 participants	3 participants	—
Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP >70 percent decrease	1 participants	0 participants	—
Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP No change or increase	8 participants	8 participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: Participants with a baseline BAP value \> ULN and at least 1 on-study value.

BAP is a measure of bone metabolism. A BAP response is calculated for participants with a baseline BAP value \> ULN. It is defined as on-study BAP values within normal limits.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=16 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=17 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Number of Participants With BAP Response	4 participants	5 participants	—

SECONDARY outcome

Timeframe: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Population: Participants who demonstrated a BAP response

The median number of months of the BAP response was calculated for participants with baseline BAP \<= ULN, from first dose of dasatinib to the first time BAP is above ULN. For participants with baseline BAP \> ULN, it was the time from BAP response to the first time BAP was above ULN. For participants with baseline BAP =\< ULN or BAP, and no BAP above ULN, last BAP assessment date was used. The median number of months of response was not defined for participants with baseline value \> ULN, that never achieved BAP response.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=4 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=5 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Median Number of Months of BAP Response	NA months Not enough participants with response had progressed; therefore, median and 95% confidence interval could not be estimated.	NA months Not enough participants with response had progressed; therefore, median and 95% confidence interval could not be estimated.	—

SECONDARY outcome

Timeframe: At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.

Population: All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.

Mean plasma concentration was obtained directly from the concentration-time data.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=25 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID n=22 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) 0 hour (n=39,18,1)	3.17 ng/mL Standard Deviation 4.03	8.15 ng/mL Standard Deviation 4.53	5.46 ng/mL Standard Deviation 0.00
Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) 1hour (n=41,19,1)	102.98 ng/mL Standard Deviation 81.80	73.05 ng/mL Standard Deviation 64.51	83.24 ng/mL Standard Deviation 0.00
Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) 3 hour (n=41,19,1)	45.28 ng/mL Standard Deviation 27.06	37.58 ng/mL Standard Deviation 25.10	23.73 ng/mL Standard Deviation 0.00
Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) 6 hour (n=41,18,1)	19.37 ng/mL Standard Deviation 13.77	15.02 ng/mL Standard Deviation 7.66	8.88 ng/mL Standard Deviation 0.00
Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) 12 hour (n=30,12,1)	16.86 ng/mL Standard Deviation 55.72	10.51 ng/mL Standard Deviation 8.98	9.89 ng/mL Standard Deviation 0.00

SECONDARY outcome

Timeframe: At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.

Population: All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.

Mean plasma concentration was obtained directly from the concentration-time data.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=25 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID n=22 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) 0 hour (n=31,8,1)	15.46 ng/mL Standard Deviation 72.21	10.61 ng/mL Standard Deviation 4.27	8.68 ng/mL Standard Deviation 0.00
Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) 1hour (n=36,9,1)	89.55 ng/mL Standard Deviation 78.64	59.75 ng/mL Standard Deviation 35.86	78.78 ng/mL Standard Deviation 0.00
Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) 3 hour (n=36,9,1)	40.10 ng/mL Standard Deviation 31.21	33.26 ng/mL Standard Deviation 16.74	29.85 ng/mL Standard Deviation 0.00
Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) 6 hour (n=36,9,1)	15.15 ng/mL Standard Deviation 8.24	16.27 ng/mL Standard Deviation 9.18	13.68 ng/mL Standard Deviation 0.00
Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) 12 hour (n=26,8,1)	17.27 ng/mL Standard Deviation 29.64	15.92 ng/mL Standard Deviation 10.34	13.93 ng/mL Standard Deviation 0.00

SECONDARY outcome

Timeframe: At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.

Population: All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.

Mean plasma concentration was obtained directly from the concentration-time data.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=25 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID n=22 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) 0 hour (n=1,1,17)	2.16 ng/mL Standard Deviation 0.00	11.69 ng/mL Standard Deviation 0.00	7.08 ng/mL Standard Deviation 3.76
Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) 1hour (n=1,1,20)	140.15 ng/mL Standard Deviation 0.00	10.37 ng/mL Standard Deviation 0.00	66.47 ng/mL Standard Deviation 43.94
Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) 3 hour (n=1,1,20)	43.50 ng/mL Standard Deviation 0.00	44.90 ng/mL Standard Deviation 0.00	27.60 ng/mL Standard Deviation 13.28
Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) 6 hour (n=1,1,19)	17.09 ng/mL Standard Deviation 0.00	52.77 ng/mL Standard Deviation 0.00	14.01 ng/mL Standard Deviation 6.06
Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) 12 hour (n=1,1,18)	24.52 ng/mL Standard Deviation 0.00	12.54 ng/mL Standard Deviation 0.00	11.91 ng/mL Standard Deviation 15.82

SECONDARY outcome

Timeframe: At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID group.

Population: All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. In treatment group (100 mg, QD), no participant received a 70 mg at PK collection day.

Mean plasma concentration was obtained directly from the concentration-time data.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=25 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID n=22 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) 0 hour (n=9,12)	—	7.29 ng/mL Standard Deviation 3.76	6.05 ng/mL Standard Deviation 3.13
Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) 1hour (n=10,11)	—	54.67 ng/mL Standard Deviation 42.75	77.83 ng/mL Standard Deviation 55.72
Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) 3 hour (n=10,12)	—	30.98 ng/mL Standard Deviation 25.78	24.17 ng/mL Standard Deviation 12.34
Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) 6 hour (n=8,11)	—	16.13 ng/mL Standard Deviation 9.77	11.81 ng/mL Standard Deviation 5.48
Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) 12 hour (n=5,11)	—	7.72 ng/mL Standard Deviation 4.24	16.29 ng/mL Standard Deviation 31.40

SECONDARY outcome

Timeframe: At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.

Population: All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.

Mean plasma concentration was obtained directly from the concentration-time data.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=25 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID n=22 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) 0 hour (n=2,2,1)	2.28 ng/mL Standard Deviation 0.67	7.39 ng/mL Standard Deviation 7.7	14.21 ng/mL Standard Deviation 0.00
Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) 1hour (n=2,2,1)	60.35 ng/mL Standard Deviation 37.22	42.15 ng/mL Standard Deviation 42.53	117.71 ng/mL Standard Deviation 0.00
Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) 3 hour (n=2,2,1)	28.38 ng/mL Standard Deviation 12.06	23.18 ng/mL Standard Deviation 22.22	57.08 ng/mL Standard Deviation 0.00
Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) 6 hour (n=2,2,1)	12.96 ng/mL Standard Deviation 2.99	6.09 ng/mL Standard Deviation 3.92	23.63 ng/mL Standard Deviation 0.00
Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) 12 hour (n=2,2,1)	47.97 ng/mL Standard Deviation 64.93	12.90 ng/mL Standard Deviation 11.13	15.92 ng/mL Standard Deviation 0.00

SECONDARY outcome

Timeframe: At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.

Population: All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.

Mean plasma concentration was obtained directly from the concentration-time data.

Outcome measures

Outcome measures
Measure	Dasatinib 100 mg Once Daily (QD) n=48 Participants Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 100 mg or 70 mg Twice Daily (BID) n=25 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.	Dasatinib 70 mg BID n=22 Participants Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
Mean Plasma Concentration at Dose 50 mg (Week 6) 0 hour (n=1,1,3)	3.54 ng/mL Standard Deviation 0.00	7.43 ng/mL Standard Deviation 0.00	3.68 ng/mL Standard Deviation 1.48
Mean Plasma Concentration at Dose 50 mg (Week 6) 1hour (n=1,1,4)	134.89 ng/mL Standard Deviation 0.00	62.62 ng/mL Standard Deviation 0.00	31.99 ng/mL Standard Deviation 22.32
Mean Plasma Concentration at Dose 50 mg (Week 6) 3 hour (n=1,1,4)	27.35 ng/mL Standard Deviation 0.00	20.65 ng/mL Standard Deviation 0.00	13.28 ng/mL Standard Deviation 2.67
Mean Plasma Concentration at Dose 50 mg (Week 6) 6 hour (n=1,1,3)	13.20 ng/mL Standard Deviation 0.00	10.29 ng/mL Standard Deviation 0.00	7.50 ng/mL Standard Deviation 1.29
Mean Plasma Concentration at Dose 50 mg (Week 6) 12 hour (n=1,1,3)	2.16 ng/mL Standard Deviation 0.00	8.33 ng/mL Standard Deviation 0.00	3.12 ng/mL Standard Deviation 0.54

Adverse Events

Dasatinib

Serious events: 21 serious events

Other events: 94 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dasatinib n=95 participants at risk All treated participants
Investigations HAEMOGLOBIN	2.1% 2/95
Investigations PLATELET COUNT	1.1% 1/95
Investigations BLOOD PRESSURE DECREASED	1.1% 1/95
Investigations GENERAL PHYSICAL CONDITION ABNORMAL	1.1% 1/95
Cardiac disorders ATRIAL FLUTTER	1.1% 1/95
Cardiac disorders ATRIAL FIBRILLATION	1.1% 1/95
Cardiac disorders MYOCARDIAL INFARCTION	1.1% 1/95
Vascular disorders ISCHAEMIA	1.1% 1/95
Gastrointestinal disorders NAUSEA	1.1% 1/95
Gastrointestinal disorders DIARRHOEA	1.1% 1/95
Gastrointestinal disorders HAEMORRHOIDS	1.1% 1/95
Gastrointestinal disorders MALLORY-WEISS SYNDROME	1.1% 1/95
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	1.1% 1/95
Infections and infestations SEPSIS	1.1% 1/95
Infections and infestations BACTERAEMIA	1.1% 1/95
Infections and infestations PYELONEPHRITIS	1.1% 1/95
Infections and infestations HUMAN EHRLICHIOSIS	1.1% 1/95
Infections and infestations ARTHRITIS INFECTIVE	1.1% 1/95
Infections and infestations URINARY TRACT INFECTION STAPHYLOCOCCAL	1.1% 1/95
Renal and urinary disorders URINARY RETENTION	1.1% 1/95
Renal and urinary disorders RENAL FAILURE ACUTE	1.1% 1/95
Renal and urinary disorders URINARY INCONTINENCE	1.1% 1/95
Renal and urinary disorders HAEMORRHAGE URINARY TRACT	1.1% 1/95
Renal and urinary disorders URINARY BLADDER HAEMORRHAGE	1.1% 1/95
Metabolism and nutrition disorders DEHYDRATION	1.1% 1/95
Metabolism and nutrition disorders MALNUTRITION	1.1% 1/95
Metabolism and nutrition disorders DECREASED APPETITE	2.1% 2/95
Blood and lymphatic system disorders ANAEMIA	1.1% 1/95
Blood and lymphatic system disorders LEUKOPENIA	1.1% 1/95
Skin and subcutaneous tissue disorders RASH	1.1% 1/95
Injury, poisoning and procedural complications COMPRESSION FRACTURE	1.1% 1/95
Musculoskeletal and connective tissue disorders BACK PAIN	2.1% 2/95
Musculoskeletal and connective tissue disorders ARTHRALGIA	1.1% 1/95
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	1.1% 1/95
Respiratory, thoracic and mediastinal disorders HYPOXIA	1.1% 1/95
Respiratory, thoracic and mediastinal disorders DYSPNOEA	2.1% 2/95
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	4.2% 4/95
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	1.1% 1/95
General disorders PYREXIA	1.1% 1/95
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	1.1% 1/95
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM PROGRESSION	2.1% 2/95

Other adverse events

Other adverse events
Measure	Dasatinib n=95 participants at risk All treated participants
Investigations WEIGHT DECREASED	13.7% 13/95
Investigations WEIGHT INCREASED	7.4% 7/95
Investigations ELECTROCARDIOGRAM QT PROLONGED	13.7% 13/95
Cardiac disorders ATRIAL FIBRILLATION	6.3% 6/95
Cardiac disorders PERICARDIAL EFFUSION	12.6% 12/95
Vascular disorders FLUSHING	10.5% 10/95
Vascular disorders HOT FLUSH	6.3% 6/95
Psychiatric disorders DEPRESSION	7.4% 7/95
Nervous system disorders HEADACHE	33.7% 32/95
Nervous system disorders DIZZINESS	12.6% 12/95
Nervous system disorders DYSGEUSIA	6.3% 6/95
Gastrointestinal disorders NAUSEA	38.9% 37/95
Gastrointestinal disorders VOMITING	14.7% 14/95
Gastrointestinal disorders DIARRHOEA	47.4% 45/95
Gastrointestinal disorders FLATULENCE	10.5% 10/95
Gastrointestinal disorders CONSTIPATION	18.9% 18/95
Gastrointestinal disorders ABDOMINAL PAIN	7.4% 7/95
Gastrointestinal disorders ABDOMINAL PAIN UPPER	5.3% 5/95
Infections and infestations RHINITIS	5.3% 5/95
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	6.3% 6/95
Renal and urinary disorders HAEMATURIA	7.4% 7/95
Metabolism and nutrition disorders DECREASED APPETITE	41.1% 39/95
Blood and lymphatic system disorders ANAEMIA	10.5% 10/95
Skin and subcutaneous tissue disorders RASH	26.3% 25/95
Skin and subcutaneous tissue disorders ALOPECIA	5.3% 5/95
Skin and subcutaneous tissue disorders DRY SKIN	6.3% 6/95
Skin and subcutaneous tissue disorders PRURITUS	7.4% 7/95
Musculoskeletal and connective tissue disorders MYALGIA	8.4% 8/95
Musculoskeletal and connective tissue disorders BACK PAIN	16.8% 16/95
Musculoskeletal and connective tissue disorders BONE PAIN	10.5% 10/95
Musculoskeletal and connective tissue disorders ARTHRALGIA	20.0% 19/95
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	7.4% 7/95
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	9.5% 9/95
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	10.5% 10/95
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	6.3% 6/95
Respiratory, thoracic and mediastinal disorders COUGH	17.9% 17/95
Respiratory, thoracic and mediastinal disorders DYSPNOEA	28.4% 27/95
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	34.7% 33/95
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	8.4% 8/95
General disorders CHILLS	5.3% 5/95
General disorders OEDEMA	8.4% 8/95
General disorders FATIGUE	46.3% 44/95
General disorders PYREXIA	17.9% 17/95
General disorders ASTHENIA	25.3% 24/95
General disorders OEDEMA PERIPHERAL	16.8% 16/95

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER