Prostate Cancer
Conditions
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.
Interventions
DRUGdasatinib
Tablets, Oral, 100 mg or 70 mg, twice daily, treatment may continue until disease progression
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 \[RECIST\]. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
France, Italy, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Dasatinib 100 mg Once Daily (QD) Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. | 48 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. | 47 |
| Total | 95 |
Baseline characteristics
| Characteristic | Dasatinib 100 mg or 70 mg Twice Daily (BID) | Dasatinib 100 mg Once Daily (QD) | Total |
|---|---|---|---|
| Age Continuous | 70.0 years | 68.0 years | 69.0 years |
| Age, Customized < 65 years | 13 participants | 12 participants | 25 participants |
| Age, Customized >=65 years | 34 participants | 36 participants | 70 participants |
| Bone-specific Alkaline Phosphatase (BAP) Value from baseline High >41.3 U/L | 19 Participants | 18 Participants | 37 Participants |
| Bone-specific Alkaline Phosphatase (BAP) Value from baseline Low <15 U/L | 2 Participants | 3 Participants | 5 Participants |
| Bone-specific Alkaline Phosphatase (BAP) Value from baseline Normal 15-41.3 U/L | 22 Participants | 26 Participants | 48 Participants |
| Bone-specific Alkaline Phosphatase (BAP) Value from baseline Unknown | 4 Participants | 1 Participants | 5 Participants |
| Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 0=normal activity | 28 participants | 35 participants | 63 participants |
| Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 1=symptoms, but fully ambulatory | 18 participants | 13 participants | 31 participants |
| Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2=symptomatic, but in bed < 50% of the day. | 1 participants | 0 participants | 1 participants |
| Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 3=needs to be in bed >50% of day, not bedridden | 0 participants | 0 participants | 0 participants |
| Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 4=unable to get out of bed | 0 participants | 0 participants | 0 participants |
| Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 5=dead | 0 participants | 0 participants | 0 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 31 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants | 15 Participants | 31 Participants |
| FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline C2 | 4.00 Units on a scale | 4.00 Units on a scale | 4.00 Units on a scale |
| FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline GE6 | 2.00 Units on a scale | 3.00 Units on a scale | 2.00 Units on a scale |
| FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline GP1 | 3.00 Units on a scale | 3.00 Units on a scale | 3.00 Units on a scale |
| FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline GP4 | 3.00 Units on a scale | 3.00 Units on a scale | 3.00 Units on a scale |
| FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline P2 | 3.00 Units on a scale | 3.00 Units on a scale | 3.00 Units on a scale |
| FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline P3 | 4.00 Units on a scale | 4.00 Units on a scale | 4.00 Units on a scale |
| FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline P7 | 4.00 Units on a scale | 4.00 Units on a scale | 4.00 Units on a scale |
| FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline P8 | 4.00 Units on a scale | 4.00 Units on a scale | 4.00 Units on a scale |
| FACT Advanced Prostate Symptom Index (FAPSI) -8 Score from baseline Total Score | 26.00 Units on a scale | 26.00 Units on a scale | 26.00 Units on a scale |
| Height continuous | 172.63 centimeter (cm) STANDARD_DEVIATION 12.67 | 174.44 centimeter (cm) STANDARD_DEVIATION 7.35 | 173.58 centimeter (cm) STANDARD_DEVIATION 10.19 |
| Race/Ethnicity, Customized Black/African American | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 45 participants | 46 participants | 91 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 47 Participants | 48 Participants | 95 Participants |
| Urinary N-telopeptide (uNTx)Value from Baseline < 60 nanomol (nmol)/mmol creatinine | 28 Participants | 26 Participants | 54 Participants |
| Urinary N-telopeptide (uNTx)Value from Baseline >= 60 nmol/mmol creatinine | 15 Participants | 20 Participants | 35 Participants |
| Urinary N-telopeptide (uNTx)Value from Baseline Unknown uNTx value | 4 Participants | 2 Participants | 6 Participants |
| Weight continuous | 89.16 kilogram (Kg) STANDARD_DEVIATION 14.72 | 92.50 kilogram (Kg) STANDARD_DEVIATION 18.25 | 90.85 kilogram (Kg) STANDARD_DEVIATION 16.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 94 / 95 |
| serious Total, serious adverse events | 21 / 95 |
Outcome results
Primary
Number of Participants With a Response
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.
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Response | 12 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Response | 13 participants |
Primary
Percentage of Participants With a Response
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.
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Percentage of Participants With a Response | 25.00 Percentage of Participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Percentage of Participants With a Response | 27.70 Percentage of Participants |
Secondary
Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2)
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.
Population: All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 6 hour (n=41,18,1) | 19.37 ng/mL | Standard Deviation 13.77 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 3 hour (n=41,19,1) | 45.28 ng/mL | Standard Deviation 27.06 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 0 hour (n=39,18,1) | 3.17 ng/mL | Standard Deviation 4.03 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 1hour (n=41,19,1) | 102.98 ng/mL | Standard Deviation 81.8 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 12 hour (n=30,12,1) | 16.86 ng/mL | Standard Deviation 55.72 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 3 hour (n=41,19,1) | 37.58 ng/mL | Standard Deviation 25.1 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 0 hour (n=39,18,1) | 8.15 ng/mL | Standard Deviation 4.53 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 1hour (n=41,19,1) | 73.05 ng/mL | Standard Deviation 64.51 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 6 hour (n=41,18,1) | 15.02 ng/mL | Standard Deviation 7.66 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 12 hour (n=30,12,1) | 10.51 ng/mL | Standard Deviation 8.98 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 12 hour (n=30,12,1) | 9.89 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 6 hour (n=41,18,1) | 8.88 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 0 hour (n=39,18,1) | 5.46 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 3 hour (n=41,19,1) | 23.73 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2) | 1hour (n=41,19,1) | 83.24 ng/mL | Standard Deviation 0 |
Secondary
Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6)
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.
Population: All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 6 hour (n=36,9,1) | 15.15 ng/mL | Standard Deviation 8.24 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 3 hour (n=36,9,1) | 40.10 ng/mL | Standard Deviation 31.21 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 0 hour (n=31,8,1) | 15.46 ng/mL | Standard Deviation 72.21 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 1hour (n=36,9,1) | 89.55 ng/mL | Standard Deviation 78.64 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 12 hour (n=26,8,1) | 17.27 ng/mL | Standard Deviation 29.64 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 3 hour (n=36,9,1) | 33.26 ng/mL | Standard Deviation 16.74 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 0 hour (n=31,8,1) | 10.61 ng/mL | Standard Deviation 4.27 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 1hour (n=36,9,1) | 59.75 ng/mL | Standard Deviation 35.86 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 6 hour (n=36,9,1) | 16.27 ng/mL | Standard Deviation 9.18 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 12 hour (n=26,8,1) | 15.92 ng/mL | Standard Deviation 10.34 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 12 hour (n=26,8,1) | 13.93 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 6 hour (n=36,9,1) | 13.68 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 0 hour (n=31,8,1) | 8.68 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 3 hour (n=36,9,1) | 29.85 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6) | 1hour (n=36,9,1) | 78.78 ng/mL | Standard Deviation 0 |
Secondary
Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2)
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.
Population: All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 6 hour (n=2,2,1) | 12.96 ng/mL | Standard Deviation 2.99 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 3 hour (n=2,2,1) | 28.38 ng/mL | Standard Deviation 12.06 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 0 hour (n=2,2,1) | 2.28 ng/mL | Standard Deviation 0.67 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 1hour (n=2,2,1) | 60.35 ng/mL | Standard Deviation 37.22 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 12 hour (n=2,2,1) | 47.97 ng/mL | Standard Deviation 64.93 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 3 hour (n=2,2,1) | 23.18 ng/mL | Standard Deviation 22.22 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 0 hour (n=2,2,1) | 7.39 ng/mL | Standard Deviation 7.7 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 1hour (n=2,2,1) | 42.15 ng/mL | Standard Deviation 42.53 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 6 hour (n=2,2,1) | 6.09 ng/mL | Standard Deviation 3.92 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 12 hour (n=2,2,1) | 12.90 ng/mL | Standard Deviation 11.13 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 12 hour (n=2,2,1) | 15.92 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 6 hour (n=2,2,1) | 23.63 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 0 hour (n=2,2,1) | 14.21 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 3 hour (n=2,2,1) | 57.08 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2) | 1hour (n=2,2,1) | 117.71 ng/mL | Standard Deviation 0 |
Secondary
Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2)
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.
Population: All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 6 hour (n=1,1,19) | 17.09 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 3 hour (n=1,1,20) | 43.50 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 0 hour (n=1,1,17) | 2.16 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 1hour (n=1,1,20) | 140.15 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 12 hour (n=1,1,18) | 24.52 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 3 hour (n=1,1,20) | 44.90 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 0 hour (n=1,1,17) | 11.69 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 1hour (n=1,1,20) | 10.37 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 6 hour (n=1,1,19) | 52.77 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 12 hour (n=1,1,18) | 12.54 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 12 hour (n=1,1,18) | 11.91 ng/mL | Standard Deviation 15.82 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 6 hour (n=1,1,19) | 14.01 ng/mL | Standard Deviation 6.06 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 0 hour (n=1,1,17) | 7.08 ng/mL | Standard Deviation 3.76 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 3 hour (n=1,1,20) | 27.60 ng/mL | Standard Deviation 13.28 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2) | 1hour (n=1,1,20) | 66.47 ng/mL | Standard Deviation 43.94 |
Secondary
Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6)
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.
Population: All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. In treatment group (100 mg, QD), no participant received a 70 mg at PK collection day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) | 1hour (n=10,11) | 54.67 ng/mL | Standard Deviation 42.75 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) | 6 hour (n=8,11) | 16.13 ng/mL | Standard Deviation 9.77 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) | 3 hour (n=10,12) | 30.98 ng/mL | Standard Deviation 25.78 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) | 12 hour (n=5,11) | 7.72 ng/mL | Standard Deviation 4.24 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) | 0 hour (n=9,12) | 7.29 ng/mL | Standard Deviation 3.76 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) | 12 hour (n=5,11) | 16.29 ng/mL | Standard Deviation 31.4 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) | 0 hour (n=9,12) | 6.05 ng/mL | Standard Deviation 3.13 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) | 1hour (n=10,11) | 77.83 ng/mL | Standard Deviation 55.72 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) | 3 hour (n=10,12) | 24.17 ng/mL | Standard Deviation 12.34 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6) | 6 hour (n=8,11) | 11.81 ng/mL | Standard Deviation 5.48 |
Secondary
Mean Plasma Concentration at Dose 50 mg (Week 6)
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.
Population: All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at Dose 50 mg (Week 6) | 6 hour (n=1,1,3) | 13.20 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at Dose 50 mg (Week 6) | 3 hour (n=1,1,4) | 27.35 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at Dose 50 mg (Week 6) | 0 hour (n=1,1,3) | 3.54 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at Dose 50 mg (Week 6) | 1hour (n=1,1,4) | 134.89 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg Once Daily (QD) | Mean Plasma Concentration at Dose 50 mg (Week 6) | 12 hour (n=1,1,3) | 2.16 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at Dose 50 mg (Week 6) | 3 hour (n=1,1,4) | 20.65 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at Dose 50 mg (Week 6) | 0 hour (n=1,1,3) | 7.43 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at Dose 50 mg (Week 6) | 1hour (n=1,1,4) | 62.62 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at Dose 50 mg (Week 6) | 6 hour (n=1,1,3) | 10.29 ng/mL | Standard Deviation 0 |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Mean Plasma Concentration at Dose 50 mg (Week 6) | 12 hour (n=1,1,3) | 8.33 ng/mL | Standard Deviation 0 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at Dose 50 mg (Week 6) | 12 hour (n=1,1,3) | 3.12 ng/mL | Standard Deviation 0.54 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at Dose 50 mg (Week 6) | 6 hour (n=1,1,3) | 7.50 ng/mL | Standard Deviation 1.29 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at Dose 50 mg (Week 6) | 0 hour (n=1,1,3) | 3.68 ng/mL | Standard Deviation 1.48 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at Dose 50 mg (Week 6) | 3 hour (n=1,1,4) | 13.28 ng/mL | Standard Deviation 2.67 |
| Dasatinib 70 mg BID | Mean Plasma Concentration at Dose 50 mg (Week 6) | 1hour (n=1,1,4) | 31.99 ng/mL | Standard Deviation 22.32 |
Secondary
Median Change From Baseline in Individual FAPSI Scores at Week 12
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.
Population: All treated participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | GP1 | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | GP4 | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | GE6 | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | C2 | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | P2 | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | P3 | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | P7 | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | P8 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | P8 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | GP1 | -1.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | P2 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | GP4 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | P7 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | GE6 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | P3 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 12 | C2 | 0.00 Units on a scale |
Secondary
Median Change From Baseline in Individual FAPSI Scores at Week 24
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.
Population: All treated participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | GP1 | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | GP4 | -0.50 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | GE6 | -0.50 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | C2 | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | P2 | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | P3 | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | P7 | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | P8 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | P8 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | GP1 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | P2 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | GP4 | -0.50 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | P7 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | GE6 | -0.50 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | P3 | 0.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Individual FAPSI Scores at Week 24 | C2 | -0.50 Units on a scale |
Secondary
Median Change From Baseline in Individual FAPSI Scores at Week 36
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.
Population: All treated participants. The number of participants for whom this data are available is too small for analysis.
Secondary
Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36
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.
Population: All treated participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 | Week 12 (n=26, 29) | 0.00 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 | Week 24 (n=14, 6) | -2.50 Units on a scale |
| Dasatinib 100 mg Once Daily (QD) | Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 | Week 36 (n=4, 5) | NA Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 | Week 12 (n=26, 29) | -2.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 | Week 24 (n=14, 6) | -2.00 Units on a scale |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 | Week 36 (n=4, 5) | NA Units on a scale |
Secondary
Median Number of Months of BAP Response
The median number of months of the BAP response was calculated for participants with baseline BAP \<= ULN, from first dose of dasatinib to the first time BAP is above ULN. For participants with baseline BAP \> ULN, it was the time from BAP response to the first time BAP was above ULN. For participants with baseline BAP =\< ULN or BAP, and no BAP above ULN, last BAP assessment date was used. The median number of months of response was not defined for participants with baseline value \> ULN, that never achieved BAP response.
Time frame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
Population: Participants who demonstrated a BAP response
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Median Number of Months of BAP Response | NA months |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Number of Months of BAP Response | NA months |
Secondary
Median Number of Months of uNTx Response
uNTx is a measure of bone metabolism.The median number of months of uNTx response was calculated for participants with baseline uNTx =\< ULN and uNTx progression during treatment, from first dose of dasatinib to uNTx progression.For participant with baseline uNTx above ULN, it was time from uNTx response to uNTx progression.For participants with baseline uNTx equal to or below ULN or uNTx response and no uNTx progression, the date of last uNTx assessment was used. Duration of uNTx response was not defined for participants with baseline value greater than ULN who never achieved uNTx responses.
Time frame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
Population: Participants who demonstrated a uNTx response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Median Number of Months of uNTx Response | NA months |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Number of Months of uNTx Response | NA months |
Secondary
Median Number of Months to Disease Progression
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.
Population: All treated participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Median Number of Months to Disease Progression | 4.7 months |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Median Number of Months to Disease Progression | 2.8 months |
Secondary
Number of Months of Decrease in PSA by at Least 50% From Baseline
PSA is a marker of prostate cancer. The duration of PSA response is measured from the time that the first of the 2 consecutive measurements met the criteria for confirmed PSA response, until the date of the first of the 3 consecutive measurements that confirm PSA progression, or the date of disease progression, or the date of death.
Time frame: Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.
Population: Participants with a decrease in PSA by at least 50% from baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Months of Decrease in PSA by at Least 50% From Baseline | 0.82 months |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Months of Decrease in PSA by at Least 50% From Baseline | 11.17 months |
Secondary
Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs
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.
Population: All treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs | Deaths | 2 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs | AEs | 48 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs | SAEs | 10 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs | All AEs Leading to Discontinuation | 13 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs | All AEs Leading to Discontinuation | 8 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs | Deaths | 2 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs | SAEs | 11 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs | AEs | 47 participants |
Secondary
Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs.
Drug-related AEs 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.
Population: All treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. | Drug-related AEs | 43 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. | Drug-related Grade 3-4 AEs | 7 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. | Drug-related AEs Leading to Discontinuation | 9 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. | Drug-related SAEs | 1 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. | Drug-related SAEs | 6 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. | Drug-related AEs | 47 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. | Drug-related AEs Leading to Discontinuation | 7 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. | Drug-related Grade 3-4 AEs | 15 participants |
Secondary
Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP
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.
Population: All treated participants who had a baseline BAP value \<=ULN and at least 1 on-study value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP | 0-35 percent decrease | 12 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP | >35-70 percent decrease | 5 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP | >70 percent decrease | 1 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP | No change or increase | 10 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP | No change or increase | 7 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP | 0-35 percent decrease | 14 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP | >70 percent decrease | 0 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP | >35-70 percent decrease | 2 participants |
Secondary
Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP
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.
Population: All treated participants who had a baseline BAP value \>ULN and at least 1 on-study value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP | 0-35 percent decrease | 6 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP | >35-70 percent decrease | 1 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP | >70 percent decrease | 1 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP | No change or increase | 8 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP | No change or increase | 8 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP | 0-35 percent decrease | 6 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP | >70 percent decrease | 0 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP | >35-70 percent decrease | 3 participants |
Secondary
Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx
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.
Population: All treated participants who had a baseline uNTx value \<=ULN and at least 1 on-study value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx | 0-35 percent decrease | 2 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx | >35-70 percent decrease | 13 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx | >70 percent decrease | 5 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx | No change or increase | 6 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx | No change or increase | 7 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx | 0-35 percent decrease | 6 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx | >70 percent decrease | 1 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx | >35-70 percent decrease | 12 participants |
Secondary
Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx
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.
Population: All treated participants who had a baseline uNTx value \>ULN and at least 1 on-study value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx | 0-35 percent decrease | 6 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx | >35-70 percent decrease | 3 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx | >70 percent decrease | 4 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx | No change or increase | 4 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx | No change or increase | 1 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx | 0-35 percent decrease | 4 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx | >70 percent decrease | 1 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx | >35-70 percent decrease | 9 participants |
Secondary
Number of Participants With Abnormal Lactate Dehydrogenase (LD)
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.
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Abnormal Lactate Dehydrogenase (LD) | 33 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Abnormal Lactate Dehydrogenase (LD) | 41 participants |
Secondary
Number of Participants With a Confirmed Improved Bone Scan
An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart.
Time frame: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.
Population: All response-evaluable participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Confirmed Improved Bone Scan | 0 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Confirmed Improved Bone Scan | 1 participants |
Secondary
Number of Participants With a Decrease in PSA by at Least 50% From Baseline
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.
Population: All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a Decrease in PSA by at Least 50% From Baseline | 1 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a Decrease in PSA by at Least 50% From Baseline | 1 participants |
Secondary
Number of Participants With a uNTx Response
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.
Population: Participants with a baseline uNTx value \> ULN and at least 1 on-study value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With a uNTx Response | 10 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With a uNTx Response | 10 participants |
Secondary
Number of Participants With BAP Response
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.
Population: Participants with a baseline BAP value \> ULN and at least 1 on-study value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With BAP Response | 4 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With BAP Response | 5 participants |
Secondary
Number of Participants With CR or PR
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.
Population: All response-evaluable participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With CR or PR | 1 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With CR or PR | 0 participants |
Secondary
Number of Participants With CR, PR or SD
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.
Population: All response-evaluable participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With CR, PR or SD | 11 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With CR, PR or SD | 12 participants |
Secondary
Number of Participants With Decrease in PSA Log Slope
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.
Population: All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Decrease in PSA Log Slope | 38 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Decrease in PSA Log Slope | 34 participants |
Secondary
Number of Participants With Decrease in PSA Velocity
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.
Population: All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Decrease in PSA Velocity | 25 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Decrease in PSA Velocity | 16 participants |
Secondary
Number of Participants With Disease Progression
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.
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Disease Progression | 30 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Disease Progression | 34 participants |
Secondary
Number of Participants With Grade 3-4 Hematology Abnormalities
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.
Population: All treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Hematology Abnormalities | Hemoglobin | 0 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Hematology Abnormalities | Leukocytes | 0 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Hematology Abnormalities | Platelet Count | 0 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Hematology Abnormalities | Absolute Neutrophil Count (ANC) | 0 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Hematology Abnormalities | Platelet Count | 1 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Hematology Abnormalities | Hemoglobin | 1 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Hematology Abnormalities | Absolute Neutrophil Count (ANC) | 1 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Hematology Abnormalities | Leukocytes | 0 participants |
Secondary
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium
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.
Population: All treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium | Alanine Aminotransferase | 0 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium | Aspartate Aminotransferase | 0 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium | Alkaline Phosphatase | 6 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium | Bilirubin | 0 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium | Hypercalcemia | 0 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium | Hypocalcemia | 1 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium | Hypercalcemia | 0 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium | Alanine Aminotransferase | 0 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium | Bilirubin | 0 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium | Aspartate Aminotransferase | 0 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium | Hypocalcemia | 0 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium | Alkaline Phosphatase | 0 participants |
Secondary
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous
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.
Population: All treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous | Creatinine | 0 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous | Hyperkalemia | 0 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous | Hypokalemia | 2 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous | Hypernatremia | 0 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous | Hyponatremia | 1 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous | Phosphorus, Inorganic | 2 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous | Hyponatremia | 1 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous | Creatinine | 0 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous | Hypernatremia | 0 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous | Hyperkalemia | 0 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous | Phosphorus, Inorganic | 2 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous | Hypokalemia | 1 participants |
Secondary
Number of Participants With Increase in PSA Doubling Time
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.
Population: All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements and positive log slope pre-treatment and on-study measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Increase in PSA Doubling Time | 34 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Increase in PSA Doubling Time | 32 participants |
Secondary
Number of Participants With Positive Urinalysis
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.
Population: All treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Positive Urinalysis | Blood | 20 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Positive Urinalysis | Glucose | 2 participants |
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With Positive Urinalysis | Protein | 21 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Positive Urinalysis | Blood | 21 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Positive Urinalysis | Glucose | 1 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With Positive Urinalysis | Protein | 26 participants |
Secondary
Number of Participants With QTc Prolongation
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.
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Number of Participants With QTc Prolongation | 3 participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Number of Participants With QTc Prolongation | 10 participants |
Secondary
Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline
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.
Population: All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline | 2.3 Percentage of Participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline | 2.3 Percentage of Participants |
Secondary
Percentage of Participants With Confirmed Improved Bone Scan
An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart.
Time frame: Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.
Population: Participants with confirmed improved bone scan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib 100 mg Once Daily (QD) | Percentage of Participants With Confirmed Improved Bone Scan | 0.0 Percentage of Participants |
| Dasatinib 100 mg or 70 mg Twice Daily (BID) | Percentage of Participants With Confirmed Improved Bone Scan | 2.6 Percentage of Participants |