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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00385580
• Collaborator: (none)
• Enrollment: 94
• Locations: 11
• Arms: 2
• Duration (Months): 45
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: dasatinib; Drug: dasatinib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: dasatinib; Tablets, Oral, 100 mg or 70 mg, twice daily, treatment may continue until disease progression; Other Names: Sprycel BMS-354825
Experimental: 2	Drug: dasatinib; Tablets, Oral, 100 mg, once daily (QD) treatment may continue until disease progression

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Response [Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.]

   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].

2. Percentage of Participants With a Response [Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.]

   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.

Secondary Outcome Measures

1. Number of Participants With a Decrease in PSA by at Least 50% From Baseline [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

   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.

2. Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

   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.

3. Number of Months of Decrease in PSA by at Least 50% From Baseline [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

   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.

4. Number of Participants With Decrease in PSA Velocity [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

   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.

5. Number of Participants With Decrease in PSA Log Slope [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

   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.

6. Number of Participants With Increase in PSA Doubling Time [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

   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.

7. Number of Participants With CR or PR [Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.]

   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

8. Number of Participants With CR, PR or SD [Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.]

   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.

9. Number of Participants With a Confirmed Improved Bone Scan [Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.]

   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.

10. Percentage of Participants With Confirmed Improved Bone Scan [Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.]

    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.

11. Number of Participants With Disease Progression [Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.]

    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.

12. Median Number of Months to Disease Progression [Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.]

    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.

13. Median Change From Baseline in Individual FAPSI Scores at Week 12 [Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.]

    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.

14. Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 [Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.]

    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).

15. Median Change From Baseline in Individual FAPSI Scores at Week 24 [Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.]

    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.

16. Median Change From Baseline in Individual FAPSI Scores at Week 36 [Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.]

    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.

17. Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs [From start of study drug therapy up to 30 days after the last dose.]

    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.

18. Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. [From start of study drug therapy up to 30 days after the last dose.]

    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.

19. Number of Participants With Grade 3-4 Hematology Abnormalities [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.]

    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.

20. Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium [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.]

    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.

21. Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous [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.]

    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.

22. Number of Participants With Abnormal Lactate Dehydrogenase (LD) [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.]

    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.

23. Number of Participants With Positive Urinalysis [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.]

    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".

24. Number of Participants With QTc Prolongation [From start of study drug therapy up to 30 days after the last dose.]

    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.

25. Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

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

26. Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

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

27. Number of Participants With a uNTx Response [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

    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.

28. Median Number of Months of uNTx Response [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

    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.

29. Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

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

30. Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

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

31. Number of Participants With BAP Response [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

    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.

32. Median Number of Months of BAP Response [Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.]

    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.

33. Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) [At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.]

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

34. Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) [At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.]

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

35. Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) [At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.]

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

36. Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) [At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID group.]

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

37. Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) [At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.]

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

38. Mean Plasma Concentration at Dose 50 mg (Week 6) [At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• males, 18 or older

• proven advanced prostate cancer

• documented metastatic disease

• rising PSA levels

• castrate levels of testosterone

Exclusion Criteria:

• symptomatic CNS (brain or spinal cord) metastasis

• medical condition which may increase the risk of toxicity

• any prior or ongoing anti-cancer medical therapy or immunotherapy for prostate cancer other than primary androgen deprivation agents

• unable to take oral medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
2	University Of Chicago	Chicago	Illinois	United States	60637
3	The Bunting Blaustein Cancer Research Building	Baltimore	Maryland	United States	21231
4	Memorial Sloan-Kettering Cancer Center-Sidney Kimmel Center	New York	New York	United States	10021
5	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
6	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
7	University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr	Madison	Wisconsin	United States	53792
8	Local Institution	Montpellier		France	34298
9	Local Institution	Paris		France	75015
10	Local Institution	Villejuif Cedex		France	94800
11	Local Institution	Rome		Italy	00152

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

• Yu EY, Wilding G, Posadas E, Gross M, Culine S, Massard C, Morris MJ, Hudes G, Calabrò F, Cheng S, Trudel GC, Paliwal P, Sternberg CN. Phase II study of dasatinib in patients with metastatic castration-resistant prostate cancer. Clin Cancer Res. 2009 Dec 1;15(23):7421-8. doi: 10.1158/1078-0432.CCR-09-1691. Epub 2009 Nov 17.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT00385580
• Other Study ID Numbers: CA180-085
• First Posted: Oct 9, 2006
• Last Update Posted: Apr 30, 2013
• Last Verified: Oct 1, 2012

• Additional relevant MeSH terms: Prostatic Neoplasms; Dasatinib

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	48	47
COMPLETED	48	47
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	48	47	95
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	68.0	70.0	69.0
Age, Customized (participants) [Number]
< 65 years	12 25%	13 27.7%	25 26.3%
>=65 years	36 75%	34 72.3%	70 73.7%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	48 100%	47 100%	95 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 4.2%	0 0%	2 2.1%
Not Hispanic or Latino	31 64.6%	31 66%	62 65.3%
Unknown or Not Reported	15 31.3%	16 34%	31 32.6%
Race/Ethnicity, Customized (participants) [Number]
White	46 95.8%	45 95.7%	91 95.8%
Black/African American	1 2.1%	2 4.3%	3 3.2%
Hispanic	1 2.1%	0 0%	1 1.1%
Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) (participants) [Number]
0=normal activity	35 72.9%	28 59.6%	63 66.3%
1=symptoms, but fully ambulatory	13 27.1%	18 38.3%	31 32.6%
2=symptomatic, but in bed < 50% of the day.	0 0%	1 2.1%	1 1.1%
3=needs to be in bed >50% of day, not bedridden	0 0%	0 0%	0 0%
4=unable to get out of bed	0 0%	0 0%	0 0%
5=dead	0 0%	0 0%	0 0%
Height continuous (centimeter (cm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter (cm)]	174.44 (7.35)	172.63 (12.67)	173.58 (10.19)
Weight continuous (kilogram (Kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram (Kg)]	92.50 (18.25)	89.16 (14.72)	90.85 (16.60)
FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline (Units on a scale) [Median (Full Range) ]
Total Score	26.00	26.00	26.00
GP1	3.00	3.00	3.00
GP4	3.00	3.00	3.00
GE6	3.00	2.00	2.00
C2	4.00	4.00	4.00
P2	3.00	3.00	3.00
P3	4.00	4.00	4.00
P7	4.00	4.00	4.00
P8	4.00	4.00	4.00
Urinary N-telopeptide (uNTx)Value from Baseline (Number) [Number]
< 60 nanomol (nmol)/mmol creatinine	26 54.2%	28 59.6%	54 56.8%
>= 60 nmol/mmol creatinine	20 41.7%	15 31.9%	35 36.8%
Unknown uNTx value	2 4.2%	4 8.5%	6 6.3%
Bone-specific Alkaline Phosphatase (BAP) Value from baseline (Number) [Number]
High >41.3 U/L	18 37.5%	19 40.4%	37 38.9%
Low <15 U/L	3 6.3%	2 4.3%	5 5.3%
Normal 15-41.3 U/L	26 54.2%	22 46.8%	48 50.5%
Unknown	1 2.1%	4 8.5%	5 5.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Response
Description	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].
Time Frame	Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Number [participants]	12 25%	13 27.7%

2. Primary Outcome

Title	Percentage of Participants With a Response
Description	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.
Time Frame	Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Number (95% Confidence Interval) [Percentage of Participants]	25.00 52.1%	27.70 58.9%

3. Secondary Outcome

Title	Number of Participants With a Decrease in PSA by at Least 50% From Baseline
Description	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.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	43	43
Number [participants]	1 2.1%	1 2.1%

4. Secondary Outcome

Title	Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline
Description	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.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	43	43
Number [Percentage of Participants]	2.3 4.8%	2.3 4.9%

5. Secondary Outcome

Title	Number of Months of Decrease in PSA by at Least 50% From Baseline
Description	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.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	1	1
Number [months]	0.82	11.17

6. Secondary Outcome

Title	Number of Participants With Decrease in PSA Velocity
Description	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.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	43	43
Number [participants]	25 52.1%	16 34%

7. Secondary Outcome

Title	Number of Participants With Decrease in PSA Log Slope
Description	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.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	43	43
Number [participants]	38 79.2%	34 72.3%

8. Secondary Outcome

Title	Number of Participants With Increase in PSA Doubling Time
Description	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.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	38	41
Number [participants]	34 70.8%	32 68.1%

9. Secondary Outcome

Title	Number of Participants With CR or PR
Description	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
Time Frame	Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Outcome Measure Data

Analysis Population Description

All response-evaluable participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	18	21
Number [participants]	1 2.1%	0 0%

10. Secondary Outcome

Title	Number of Participants With CR, PR or SD
Description	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.
Time Frame	Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Outcome Measure Data

Analysis Population Description

All response-evaluable participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	18	21
Number [participants]	11 22.9%	12 25.5%

11. Secondary Outcome

Title	Number of Participants With a Confirmed Improved Bone Scan
Description	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.
Time Frame	Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Outcome Measure Data

Analysis Population Description

All response-evaluable participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	40	38
Number [participants]	0 0%	1 2.1%

12. Secondary Outcome

Title	Percentage of Participants With Confirmed Improved Bone Scan
Description	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.
Time Frame	Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Outcome Measure Data

Analysis Population Description

Participants with confirmed improved bone scan.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	40	38
Number [Percentage of Participants]	0.0 0%	2.6 5.5%

13. Secondary Outcome

Title	Number of Participants With Disease Progression
Description	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.
Time Frame	Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Number [participants]	30 62.5%	34 72.3%

14. Secondary Outcome

Title	Median Number of Months to Disease Progression
Description	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.
Time Frame	Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Median (95% Confidence Interval) [months]	4.7	2.8

15. Secondary Outcome

Title	Median Change From Baseline in Individual FAPSI Scores at Week 12
Description	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.
Time Frame	Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
GP1	0.00	-1.00
GP4	0.00	0.00
GE6	0.00	0.00
C2	0.00	0.00
P2	0.00	0.00
P3	0.00	0.00
P7	0.00	0.00
P8	0.00	0.00

16. Secondary Outcome

Title	Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36
Description	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).
Time Frame	Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Week 12 (n=26, 29)	0.00	-2.00
Week 24 (n=14, 6)	-2.50	-2.00
Week 36 (n=4, 5)	NA	NA

17. Secondary Outcome

Title	Median Change From Baseline in Individual FAPSI Scores at Week 24
Description	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.
Time Frame	Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
GP1	0.00	0.00
GP4	-0.50	-0.50
GE6	-0.50	-0.50
C2	0.00	-0.50
P2	0.00	0.00
P3	0.00	0.00
P7	0.00	0.00
P8	0.00	0.00

18. Secondary Outcome

Title	Median Change From Baseline in Individual FAPSI Scores at Week 36
Description	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.
Time Frame	Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	0	0

19. Secondary Outcome

Title	Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs
Description	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.
Time Frame	From start of study drug therapy up to 30 days after the last dose.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Deaths	2 4.2%	2 4.3%
AEs	48 100%	47 100%
SAEs	10 20.8%	11 23.4%
All AEs Leading to Discontinuation	13 27.1%	8 17%

20. Secondary Outcome

Title	Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs.
Description	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.
Time Frame	From start of study drug therapy up to 30 days after the last dose.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Drug-related SAEs	1 2.1%	6 12.8%
Drug-related AEs	43 89.6%	47 100%
Drug-related Grade 3-4 AEs	7 14.6%	15 31.9%
Drug-related AEs Leading to Discontinuation	9 18.8%	7 14.9%

21. Secondary Outcome

Title	Number of Participants With Grade 3-4 Hematology Abnormalities
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Absolute Neutrophil Count (ANC)	0 0%	1 2.1%
Hemoglobin	0 0%	1 2.1%
Platelet Count	0 0%	1 2.1%
Leukocytes	0 0%	0 0%

22. Secondary Outcome

Title	Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Alanine Aminotransferase	0 0%	0 0%
Aspartate Aminotransferase	0 0%	0 0%
Alkaline Phosphatase	6 12.5%	0 0%
Bilirubin	0 0%	0 0%
Hypercalcemia	0 0%	0 0%
Hypocalcemia	1 2.1%	0 0%

23. Secondary Outcome

Title	Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Creatinine	0 0%	0 0%
Hyperkalemia	0 0%	0 0%
Hypokalemia	2 4.2%	1 2.1%
Hypernatremia	0 0%	0 0%
Hyponatremia	1 2.1%	1 2.1%
Phosphorus, Inorganic	2 4.2%	2 4.3%

24. Secondary Outcome

Title	Number of Participants With Abnormal Lactate Dehydrogenase (LD)
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Number [participants]	33 68.8%	41 87.2%

25. Secondary Outcome

Title	Number of Participants With Positive Urinalysis
Description	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".
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Blood	20 41.7%	21 44.7%
Glucose	2 4.2%	1 2.1%
Protein	21 43.8%	26 55.3%

26. Secondary Outcome

Title	Number of Participants With QTc Prolongation
Description	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.
Time Frame	From start of study drug therapy up to 30 days after the last dose.

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	48	47
Number [participants]	3 6.3%	10 21.3%

27. Secondary Outcome

Title	Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx
Description	uNTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	26	26
0-35 percent decrease	2 4.2%	6 12.8%
>35-70 percent decrease	13 27.1%	12 25.5%
>70 percent decrease	5 10.4%	1 2.1%
No change or increase	6 12.5%	7 14.9%

28. Secondary Outcome

Title	Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx
Description	uNTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	17	15
0-35 percent decrease	6 12.5%	4 8.5%
>35-70 percent decrease	3 6.3%	9 19.1%
>70 percent decrease	4 8.3%	1 2.1%
No change or increase	4 8.3%	1 2.1%

29. Secondary Outcome

Title	Number of Participants With a uNTx Response
Description	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.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	17	15
Number [participants]	10 20.8%	10 21.3%

30. Secondary Outcome

Title	Median Number of Months of uNTx Response
Description	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.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

Participants who demonstrated a uNTx response.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	10	10
Median (95% Confidence Interval) [months]	NA	NA

31. Secondary Outcome

Title	Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP
Description	BAP is a measure of bone metabolism. A decrease in BAP relative to the baseline indicates decrease in bone metabolism.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	28	23
0-35 percent decrease	12 25%	14 29.8%
>35-70 percent decrease	5 10.4%	2 4.3%
>70 percent decrease	1 2.1%	0 0%
No change or increase	10 20.8%	7 14.9%

32. Secondary Outcome

Title	Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP
Description	BAP is a measure of bone metabolism. A decrease in BAP relative to baseline indicates a decrease in bone metabolism.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	16	17
0-35 percent decrease	6 12.5%	6 12.8%
>35-70 percent decrease	1 2.1%	3 6.4%
>70 percent decrease	1 2.1%	0 0%
No change or increase	8 16.7%	8 17%

33. Secondary Outcome

Title	Number of Participants With BAP Response
Description	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.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	16	17
Number [participants]	4 8.3%	5 10.6%

34. Secondary Outcome

Title	Median Number of Months of BAP Response
Description	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.
Time Frame	Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.

Outcome Measure Data

Analysis Population Description

Participants who demonstrated a BAP response

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg or 70 mg Twice Daily (BID)
Arm/Group Description	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.	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.
Measure Participants	4	5
Median (95% Confidence Interval) [months]	NA	NA

35. Secondary Outcome

Title	Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2)
Description	Mean plasma concentration was obtained directly from the concentration-time data.
Time Frame	At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg Twice Daily (BID)	Dasatinib 70 mg BID
Arm/Group Description	Participants were administered an oral dose of 100 mg dasatinib tablet QD (100 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.	Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (100 dose). Of the 47 treated participants in the BID group, 25 received 100 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.	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.
Measure Participants	48	25	22
0 hour (n=39,18,1)	3.17 (4.03)	8.15 (4.53)	5.46 (0.00)
1hour (n=41,19,1)	102.98 (81.80)	73.05 (64.51)	83.24 (0.00)
3 hour (n=41,19,1)	45.28 (27.06)	37.58 (25.10)	23.73 (0.00)
6 hour (n=41,18,1)	19.37 (13.77)	15.02 (7.66)	8.88 (0.00)
12 hour (n=30,12,1)	16.86 (55.72)	10.51 (8.98)	9.89 (0.00)

36. Secondary Outcome

Title	Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6)
Description	Mean plasma concentration was obtained directly from the concentration-time data.
Time Frame	At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg Twice Daily (BID)	Dasatinib 70 mg BID
Arm/Group Description	Participants were administered an oral dose of 100 mg dasatinib tablet QD (100 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.	Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (100 dose). Of the 47 treated participants in the BID group, 25 received 100 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.	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.
Measure Participants	48	25	22
0 hour (n=31,8,1)	15.46 (72.21)	10.61 (4.27)	8.68 (0.00)
1hour (n=36,9,1)	89.55 (78.64)	59.75 (35.86)	78.78 (0.00)
3 hour (n=36,9,1)	40.10 (31.21)	33.26 (16.74)	29.85 (0.00)
6 hour (n=36,9,1)	15.15 (8.24)	16.27 (9.18)	13.68 (0.00)
12 hour (n=26,8,1)	17.27 (29.64)	15.92 (10.34)	13.93 (0.00)

37. Secondary Outcome

Title	Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2)
Description	Mean plasma concentration was obtained directly from the concentration-time data.
Time Frame	At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg Twice Daily (BID)	Dasatinib 70 mg BID
Arm/Group Description	Participants were administered an oral dose of 100 mg dasatinib tablet QD (70 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.	Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (70 dose). Of the 47 treated participants in the BID group, 25 received 100 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.	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 (70 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.
Measure Participants	48	25	22
0 hour (n=1,1,17)	2.16 (0.00)	11.69 (0.00)	7.08 (3.76)
1hour (n=1,1,20)	140.15 (0.00)	10.37 (0.00)	66.47 (43.94)
3 hour (n=1,1,20)	43.50 (0.00)	44.90 (0.00)	27.60 (13.28)
6 hour (n=1,1,19)	17.09 (0.00)	52.77 (0.00)	14.01 (6.06)
12 hour (n=1,1,18)	24.52 (0.00)	12.54 (0.00)	11.91 (15.82)

38. Secondary Outcome

Title	Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6)
Description	Mean plasma concentration was obtained directly from the concentration-time data.
Time Frame	At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID group.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg Twice Daily (BID)	Dasatinib 70 mg BID
Arm/Group Description	Participants were administered an oral dose of 100 mg dasatinib tablet QD (70 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.	Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (70 dose). Of the 47 treated participants in the BID group, 25 received 100 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.	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 (70 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.
Measure Participants	0	25	22
0 hour (n=9,12)	7.29 (3.76)	6.05 (3.13)
1hour (n=10,11)	54.67 (42.75)	77.83 (55.72)
3 hour (n=10,12)	30.98 (25.78)	24.17 (12.34)
6 hour (n=8,11)	16.13 (9.77)	11.81 (5.48)
12 hour (n=5,11)	7.72 (4.24)	16.29 (31.40)

39. Secondary Outcome

Title	Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2)
Description	Mean plasma concentration was obtained directly from the concentration-time data.
Time Frame	At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg Twice Daily (BID)	Dasatinib 70 mg BID
Arm/Group Description	Participants were administered an oral dose of 100 mg dasatinib tablet QD (50 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.	Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (50 dose). Of the 47 treated participants in the BID group, 25 received 100 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.	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 (50 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.
Measure Participants	48	25	22
0 hour (n=2,2,1)	2.28 (0.67)	7.39 (7.7)	14.21 (0.00)
1hour (n=2,2,1)	60.35 (37.22)	42.15 (42.53)	117.71 (0.00)
3 hour (n=2,2,1)	28.38 (12.06)	23.18 (22.22)	57.08 (0.00)
6 hour (n=2,2,1)	12.96 (2.99)	6.09 (3.92)	23.63 (0.00)
12 hour (n=2,2,1)	47.97 (64.93)	12.90 (11.13)	15.92 (0.00)

40. Secondary Outcome

Title	Mean Plasma Concentration at Dose 50 mg (Week 6)
Description	Mean plasma concentration was obtained directly from the concentration-time data.
Time Frame	At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dasatinib 100 mg Once Daily (QD)	Dasatinib 100 mg Twice Daily (BID)	Dasatinib 70 mg BID
Arm/Group Description	Participants were administered an oral dose of 100 mg dasatinib tablet QD (50 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.	Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (X dose). Of the 47 treated participants in the BID group, 25 received 100 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.	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 (X 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.
Measure Participants	48	25	22
0 hour (n=1,1,3)	3.54 (0.00)	7.43 (0.00)	3.68 (1.48)
1hour (n=1,1,4)	134.89 (0.00)	62.62 (0.00)	31.99 (22.32)
3 hour (n=1,1,4)	27.35 (0.00)	20.65 (0.00)	13.28 (2.67)
6 hour (n=1,1,3)	13.20 (0.00)	10.29 (0.00)	7.50 (1.29)
12 hour (n=1,1,3)	2.16 (0.00)	8.33 (0.00)	3.12 (0.54)

Adverse Events

Arm/Group Title	Dasatinib
Arm/Group Description	All treated participants
All Cause Mortality
	Dasatinib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Dasatinib
	Affected / at Risk (%)	# Events
Total	21/95 (22.1%)
Blood and lymphatic system disorders
ANAEMIA	1/95 (1.1%)
LEUKOPENIA	1/95 (1.1%)
Cardiac disorders
ATRIAL FLUTTER	1/95 (1.1%)
ATRIAL FIBRILLATION	1/95 (1.1%)
MYOCARDIAL INFARCTION	1/95 (1.1%)
Gastrointestinal disorders
NAUSEA	1/95 (1.1%)
DIARRHOEA	1/95 (1.1%)
HAEMORRHOIDS	1/95 (1.1%)
MALLORY-WEISS SYNDROME	1/95 (1.1%)
GASTROINTESTINAL HAEMORRHAGE	1/95 (1.1%)
General disorders
PYREXIA	1/95 (1.1%)
Infections and infestations
SEPSIS	1/95 (1.1%)
BACTERAEMIA	1/95 (1.1%)
PYELONEPHRITIS	1/95 (1.1%)
HUMAN EHRLICHIOSIS	1/95 (1.1%)
ARTHRITIS INFECTIVE	1/95 (1.1%)
URINARY TRACT INFECTION STAPHYLOCOCCAL	1/95 (1.1%)
Injury, poisoning and procedural complications
COMPRESSION FRACTURE	1/95 (1.1%)
Investigations
HAEMOGLOBIN	2/95 (2.1%)
PLATELET COUNT	1/95 (1.1%)
BLOOD PRESSURE DECREASED	1/95 (1.1%)
GENERAL PHYSICAL CONDITION ABNORMAL	1/95 (1.1%)
Metabolism and nutrition disorders
DEHYDRATION	1/95 (1.1%)
MALNUTRITION	1/95 (1.1%)
DECREASED APPETITE	2/95 (2.1%)
Musculoskeletal and connective tissue disorders
BACK PAIN	2/95 (2.1%)
ARTHRALGIA	1/95 (1.1%)
MUSCULAR WEAKNESS	1/95 (1.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA	1/95 (1.1%)
MALIGNANT NEOPLASM PROGRESSION	2/95 (2.1%)
Renal and urinary disorders
URINARY RETENTION	1/95 (1.1%)
RENAL FAILURE ACUTE	1/95 (1.1%)
URINARY INCONTINENCE	1/95 (1.1%)
HAEMORRHAGE URINARY TRACT	1/95 (1.1%)
URINARY BLADDER HAEMORRHAGE	1/95 (1.1%)
Respiratory, thoracic and mediastinal disorders
HYPOXIA	1/95 (1.1%)
DYSPNOEA	2/95 (2.1%)
PLEURAL EFFUSION	4/95 (4.2%)
DYSPNOEA EXERTIONAL	1/95 (1.1%)
Skin and subcutaneous tissue disorders
RASH	1/95 (1.1%)
Vascular disorders
ISCHAEMIA	1/95 (1.1%)
Other (Not Including Serious) Adverse Events
	Dasatinib
	Affected / at Risk (%)	# Events
Total	94/95 (98.9%)
Blood and lymphatic system disorders
ANAEMIA	10/95 (10.5%)
Cardiac disorders
ATRIAL FIBRILLATION	6/95 (6.3%)
PERICARDIAL EFFUSION	12/95 (12.6%)
Gastrointestinal disorders
NAUSEA	37/95 (38.9%)
VOMITING	14/95 (14.7%)
DIARRHOEA	45/95 (47.4%)
FLATULENCE	10/95 (10.5%)
CONSTIPATION	18/95 (18.9%)
ABDOMINAL PAIN	7/95 (7.4%)
ABDOMINAL PAIN UPPER	5/95 (5.3%)
General disorders
CHILLS	5/95 (5.3%)
OEDEMA	8/95 (8.4%)
FATIGUE	44/95 (46.3%)
PYREXIA	17/95 (17.9%)
ASTHENIA	24/95 (25.3%)
OEDEMA PERIPHERAL	16/95 (16.8%)
Infections and infestations
RHINITIS	5/95 (5.3%)
UPPER RESPIRATORY TRACT INFECTION	6/95 (6.3%)
Investigations
WEIGHT DECREASED	13/95 (13.7%)
WEIGHT INCREASED	7/95 (7.4%)
ELECTROCARDIOGRAM QT PROLONGED	13/95 (13.7%)
Metabolism and nutrition disorders
DECREASED APPETITE	39/95 (41.1%)
Musculoskeletal and connective tissue disorders
MYALGIA	8/95 (8.4%)
BACK PAIN	16/95 (16.8%)
BONE PAIN	10/95 (10.5%)
ARTHRALGIA	19/95 (20%)
MUSCULAR WEAKNESS	7/95 (7.4%)
PAIN IN EXTREMITY	9/95 (9.5%)
MUSCULOSKELETAL PAIN	10/95 (10.5%)
MUSCULOSKELETAL CHEST PAIN	6/95 (6.3%)
Nervous system disorders
HEADACHE	32/95 (33.7%)
DIZZINESS	12/95 (12.6%)
DYSGEUSIA	6/95 (6.3%)
Psychiatric disorders
DEPRESSION	7/95 (7.4%)
Renal and urinary disorders
HAEMATURIA	7/95 (7.4%)
Respiratory, thoracic and mediastinal disorders
COUGH	17/95 (17.9%)
DYSPNOEA	27/95 (28.4%)
PLEURAL EFFUSION	33/95 (34.7%)
DYSPNOEA EXERTIONAL	8/95 (8.4%)
Skin and subcutaneous tissue disorders
RASH	25/95 (26.3%)
ALOPECIA	5/95 (5.3%)
DRY SKIN	6/95 (6.3%)
PRURITUS	7/95 (7.4%)
Vascular disorders
FLUSHING	10/95 (10.5%)
HOT FLUSH	6/95 (6.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.