Trial Outcomes & Findings for A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy (NCT NCT00473512)
NCT ID: NCT00473512
Last Updated: 2014-03-27
Results Overview
The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2014-03-27
Participant Flow
Participant milestones
| Measure |
250 mg/Day
Abiraterone acetate 250 milligram (mg) capsule administered orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. Participants received MTD (1000 mg) of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
500 mg/Day
Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
750 mg/Day
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Period 1 (Phase 1)
STARTED
|
3
|
3
|
3
|
42
|
3
|
|
Period 1 (Phase 1)
COMPLETED
|
2
|
2
|
3
|
25
|
2
|
|
Period 1 (Phase 1)
NOT COMPLETED
|
1
|
1
|
0
|
17
|
1
|
|
Period 2 (Phase 2)
STARTED
|
1
|
2
|
2
|
23
|
2
|
|
Period 2 (Phase 2)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Phase 2)
NOT COMPLETED
|
1
|
2
|
2
|
23
|
2
|
Reasons for withdrawal
| Measure |
250 mg/Day
Abiraterone acetate 250 milligram (mg) capsule administered orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. Participants received MTD (1000 mg) of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
500 mg/Day
Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
750 mg/Day
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Period 1 (Phase 1)
Adverse Event
|
0
|
0
|
0
|
5
|
0
|
|
Period 1 (Phase 1)
Death
|
0
|
0
|
0
|
1
|
0
|
|
Period 1 (Phase 1)
Disease Progression
|
1
|
1
|
0
|
10
|
1
|
|
Period 1 (Phase 1)
Other
|
0
|
0
|
0
|
1
|
0
|
|
Period 2 (Phase 2)
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
|
Period 2 (Phase 2)
Death
|
0
|
0
|
0
|
1
|
1
|
|
Period 2 (Phase 2)
Disease Progression
|
0
|
2
|
2
|
17
|
1
|
|
Period 2 (Phase 2)
Symptomatic Deterioration
|
0
|
0
|
0
|
1
|
0
|
|
Period 2 (Phase 2)
Other
|
1
|
0
|
0
|
3
|
0
|
Baseline Characteristics
A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy
Baseline characteristics by cohort
| Measure |
250 mg/Day
n=3 Participants
Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
500 mg/Day
n=3 Participants
Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
750 mg/Day
n=3 Participants
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
n=42 Participants
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
n=3 Participants
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
68.7 years
STANDARD_DEVIATION 10.41 • n=7 Participants
|
76 years
STANDARD_DEVIATION 8.19 • n=5 Participants
|
70.4 years
STANDARD_DEVIATION 7.42 • n=4 Participants
|
68 years
STANDARD_DEVIATION 12.17 • n=21 Participants
|
69.9 years
STANDARD_DEVIATION 8.04 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
54 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response.
Outcome measures
| Measure |
1000 mg AA Monotherapy
n=11 Participants
Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
|
1000 mg AA Therapy
n=29 Participants
Participants received 1000 mg abiraterone acetate with or without dexamethasone.
|
750 mg/Day
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12
|
10 Participants
|
25 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of study (1160 days)Population: All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
Outcome measures
| Measure |
1000 mg AA Monotherapy
n=38 Participants
Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
|
1000 mg AA Therapy
Participants received 1000 mg abiraterone acetate with or without dexamethasone.
|
750 mg/Day
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Number of Participants With Objective Tumor Response
Complete response
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Objective Tumor Response
Partial response
|
8 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of study (1160 days)Population: All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
Duration of PSA response in participants on abiraterone acetate therapy was measured as the duration between PSA 50 percent decline date and PSA progression date as defined by the PSAWG criteria.
Outcome measures
| Measure |
1000 mg AA Monotherapy
n=27 Participants
Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
|
1000 mg AA Therapy
Participants received 1000 mg abiraterone acetate with or without dexamethasone.
|
750 mg/Day
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Duration of Prostate Specific Antigen (PSA) Response
|
141 Days
Interval 85.0 to 235.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of study (1160 days)Population: Duration of response was not analyzed as majority of participants with objective tumor response were lost to follow-up.
Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to end of study (1160 days)Population: Data was not analyzed because at the time to progression, participants also received dexamethasone treatment, making it impractical to accurately define disease progression.
Disease progression was defined as greater than 25 percent increase in sum of longest diameter of target lesions compared to baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to end of study (1160 days)Population: Data was not analyzed due to high number of participants censored for survival.
Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Cycle 2 (within 3 days prior to Day 29)Population: All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point.
Concentration of testosterone in blood was measured in nanogram per deciliter (ng/dL).
Outcome measures
| Measure |
1000 mg AA Monotherapy
n=28 Participants
Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
|
1000 mg AA Therapy
Participants received 1000 mg abiraterone acetate with or without dexamethasone.
|
750 mg/Day
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Serum Blood Levels of Testosterone
Cycle 2 (n = 28)
|
1 ng/dL
Interval 1.0 to 186.0
|
—
|
—
|
—
|
—
|
|
Serum Blood Levels of Testosterone
Baseline (n = 23)
|
3 ng/dL
Interval 1.0 to 10.0
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 30 days after the last dose of study medicationPopulation: Included all participants who received any amount of the study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
1000 mg AA Monotherapy
n=3 Participants
Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
|
1000 mg AA Therapy
n=3 Participants
Participants received 1000 mg abiraterone acetate with or without dexamethasone.
|
750 mg/Day
n=3 Participants
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
n=42 Participants
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
n=3 Participants
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
AEs
|
3 participants
|
3 participants
|
3 participants
|
41 participants
|
3 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
|
2 participants
|
2 participants
|
0 participants
|
20 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Cycle 2 (within 3 days prior to Day 29)Population: All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point.
Concentration of Cortisol, Aldosterone, Corticosterone, 11-Deoxycortisol, Deoxycorticosterone and Dehydroepiandrostenedione Sulphate (DHEA-S) in blood was measured in nanogram per deciliter (ng/dL).
Outcome measures
| Measure |
1000 mg AA Monotherapy
n=33 Participants
Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
|
1000 mg AA Therapy
Participants received 1000 mg abiraterone acetate with or without dexamethasone.
|
750 mg/Day
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Serum Blood Levels of Testosterone Precursors
Cortisol; Baseline (n = 33)
|
12000 ng/dL
Interval 7000.0 to 23000.0
|
—
|
—
|
—
|
—
|
|
Serum Blood Levels of Testosterone Precursors
Cortisol; Cycle 2 (n = 29)
|
4000 ng/dL
Interval 1000.0 to 11000.0
|
—
|
—
|
—
|
—
|
|
Serum Blood Levels of Testosterone Precursors
Aldosterone; Cycle 2 (n=29)
|
8 ng/dL
Interval 1.0 to 61.0
|
—
|
—
|
—
|
—
|
|
Serum Blood Levels of Testosterone Precursors
Corticosterone; Baseline (n=33)
|
193 ng/dL
Interval 4.0 to 1041.0
|
—
|
—
|
—
|
—
|
|
Serum Blood Levels of Testosterone Precursors
Corticosterone; Cycle 2 (n=27)
|
6797 ng/dL
Interval 12.0 to 17148.0
|
—
|
—
|
—
|
—
|
|
Serum Blood Levels of Testosterone Precursors
11-Deoxycortisol; Baseline (n=31)
|
39 ng/dL
Interval 20.0 to 233.0
|
—
|
—
|
—
|
—
|
|
Serum Blood Levels of Testosterone Precursors
11-Deoxycortisol; Cycle 2 (n=25)
|
73 ng/dL
Interval 20.0 to 836.0
|
—
|
—
|
—
|
—
|
|
Serum Blood Levels of Testosterone Precursors
Deoxycorticosterone; Baseline (n=32)
|
6 ng/dL
Interval 2.0 to 31.0
|
—
|
—
|
—
|
—
|
|
Serum Blood Levels of Testosterone Precursors
Deoxycorticosterone; Cycle 2 (n=28)
|
121 ng/dL
Interval 33.0 to 1627.0
|
—
|
—
|
—
|
—
|
|
Serum Blood Levels of Testosterone Precursors
DHEA-S; Baseline (n=32)
|
30000 ng/dL
Interval 15000.0 to 176000.0
|
—
|
—
|
—
|
—
|
|
Serum Blood Levels of Testosterone Precursors
DHEA-S; Cycle 2 (n=28)
|
15000 ng/dL
Interval 15000.0 to 15000.0
|
—
|
—
|
—
|
—
|
|
Serum Blood Levels of Testosterone Precursors
Aldosterone; Baseline (n=33)
|
8 ng/dL
Interval 1.0 to 32.0
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 12 cyclesPopulation: Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.
The time from start of study treatment to the development/worsening of pain due to prostate cancer requiring one or more of the following treatments: 1- Opioid therapy (therapy with morphine like medicines for 10 out of 14 consecutive days); 2- Glucocorticoid therapy; 3- Initiation of \>= 5 mg of prednisolone for 10 out of 14 consecutive days; 4- Radionuclide therapy; 5- Radiation therapy (x-ray or cobalt treatment); 6- Chemotherapy (treatment of disease by chemical agents). Participants who do not experience prostate cancer pain were censored on their last day on study. Time to prostate cancer pain progression was measured by Kaplan-Meier method.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Cycle 2, 4, 8, 12Population: Data was reported in individual participant listings but not summarized due to statistical constraints.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was givenPopulation: Data was not statistically summarized but reported in individual participant listing as per planned analysis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was givenPopulation: Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The Cmax is defined as maximum observed analyte concentration.
Outcome measures
| Measure |
1000 mg AA Monotherapy
n=3 Participants
Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
|
1000 mg AA Therapy
n=3 Participants
Participants received 1000 mg abiraterone acetate with or without dexamethasone.
|
750 mg/Day
n=2 Participants
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
n=9 Participants
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
n=3 Participants
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Abiraterone
|
219 nmol/L
Standard Deviation 172.77
|
284 nmol/L
Standard Deviation 132.38
|
1032 nmol/L
Standard Deviation 344.01
|
571 nmol/L
Standard Deviation 443.18
|
531 nmol/L
Standard Deviation 219.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was givenPopulation: Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration. The analyte concentration associated with Tmax is referred to as Cmax.
Outcome measures
| Measure |
1000 mg AA Monotherapy
n=3 Participants
Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
|
1000 mg AA Therapy
n=3 Participants
Participants received 1000 mg abiraterone acetate with or without dexamethasone.
|
750 mg/Day
n=2 Participants
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
n=9 Participants
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
n=3 Participants
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone
|
2.050 hours
Standard Deviation 0.02
|
2.588 hours
Standard Deviation 1.02
|
1.709 hours
Standard Deviation 0.41
|
3.159 hours
Standard Deviation 1.79
|
2.672 hours
Standard Deviation 1.14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was givenPopulation: Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
Area under the plasma concentration time-curve from time zero to the last quantifiable concentration (AUClast).
Outcome measures
| Measure |
1000 mg AA Monotherapy
n=3 Participants
Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
|
1000 mg AA Therapy
n=3 Participants
Participants received 1000 mg abiraterone acetate with or without dexamethasone.
|
750 mg/Day
n=2 Participants
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
n=9 Participants
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
n=3 Participants
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Abiraterone
|
1253 hours*nmol/L
Standard Deviation 519.78
|
1334 hours*nmol/L
Standard Deviation 731.47
|
4294 hours*nmol/L
Standard Deviation 1295.20
|
4371 hours*nmol/L
Standard Deviation 3427.54
|
4754 hours*nmol/L
Standard Deviation 1659.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was givenPopulation: Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Outcome measures
| Measure |
1000 mg AA Monotherapy
n=3 Participants
Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
|
1000 mg AA Therapy
n=3 Participants
Participants received 1000 mg abiraterone acetate with or without dexamethasone.
|
750 mg/Day
n=2 Participants
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
n=9 Participants
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
n=3 Participants
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Abiraterone
|
1369 hours*nmol/L
Standard Deviation 505.39
|
1448 hours*nmol/L
Standard Deviation 749.01
|
4537 hours*nmol/L
Standard Deviation 1333.42
|
4615 hours*nmol/L
Standard Deviation 3660.48
|
4983 hours*nmol/L
Standard Deviation 1755.24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was givenPopulation: Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
1000 mg AA Monotherapy
n=3 Participants
Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
|
1000 mg AA Therapy
n=3 Participants
Participants received 1000 mg abiraterone acetate with or without dexamethasone.
|
750 mg/Day
n=2 Participants
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
n=9 Participants
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
n=3 Participants
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Plasma Decay Half-Life (t1/2) of Abiraterone
|
11.6 hour
Standard Deviation 10.14
|
9.5 hour
Standard Deviation 7.02
|
10.8 hour
Standard Deviation 5.91
|
10.6 hour
Standard Deviation 4.69
|
12.0 hour
Standard Deviation 2.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was givenPopulation: Data was not statistically summarized but reported in individual participant listing as per planned analysis.
The actual sampling time of last measurable (non-below the limit of quantification \[BQL\]) analyte concentration. The analyte concentration associated with Tlast is referred to as Clast.
Outcome measures
Outcome data not reported
Adverse Events
250 mg/Day
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
500 mg/Day
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
750 mg/Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1000 mg/Day
Serious events: 20 serious events
Other events: 41 other events
Deaths: 0 deaths
2000 mg/Day
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
250 mg/Day
n=3 participants at risk
Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
500 mg/Day
n=3 participants at risk
Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
750 mg/Day
n=3 participants at risk
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
n=42 participants at risk
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
n=3 participants at risk
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Oedema peripheral
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
33.3%
1/3
|
|
General disorders
Pain
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Infections and infestations
Infection
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Infections and infestations
Lower respiratory tract infection
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Infections and infestations
Lyme disease
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
4.8%
2/42
|
0.00%
0/3
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
4.8%
2/42
|
0.00%
0/3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
33.3%
1/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Nervous system disorders
Migraine
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Psychiatric disorders
Confusional state
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
4.8%
2/42
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
4.8%
2/42
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
4.8%
2/42
|
0.00%
0/3
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Vascular disorders
Vasculitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
Other adverse events
| Measure |
250 mg/Day
n=3 participants at risk
Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
500 mg/Day
n=3 participants at risk
Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
750 mg/Day
n=3 participants at risk
Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
1000 mg/Day
n=42 participants at risk
Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
2000 mg/Day
n=3 participants at risk
Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
4.8%
2/42
|
33.3%
1/3
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
33.3%
1/3
|
|
Eye disorders
Eye inflammation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
33.3%
1/3
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
33.3%
1/3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
33.3%
1/3
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3
|
0.00%
0/3
|
33.3%
1/3
|
26.2%
11/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
21.4%
9/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
9.5%
4/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
4.8%
2/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Mouth ulceration
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
4.8%
2/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3
|
0.00%
0/3
|
66.7%
2/3
|
11.9%
5/42
|
33.3%
1/3
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
33.3%
1/3
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
33.3%
1/3
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3
|
0.00%
0/3
|
33.3%
1/3
|
19.0%
8/42
|
33.3%
1/3
|
|
General disorders
Chest discomfort
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Facial pain
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
General disorders
Fatigue
|
66.7%
2/3
|
33.3%
1/3
|
66.7%
2/3
|
50.0%
21/42
|
66.7%
2/3
|
|
General disorders
Feeling cold
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
General disorders
Inflammation
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
General disorders
Influenza like illness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
9.5%
4/42
|
0.00%
0/3
|
|
General disorders
Injection site discolouration
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
General disorders
Oedema peripheral
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
45.2%
19/42
|
100.0%
3/3
|
|
General disorders
Pitting oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
4.8%
2/42
|
66.7%
2/3
|
|
General disorders
Pyrexia
|
33.3%
1/3
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
33.3%
1/3
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/42
|
33.3%
1/3
|
|
Infections and infestations
Gingival infection
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Infections and infestations
Groin abscess
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Infections and infestations
Lower respiratory tract infection
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
11.9%
5/42
|
0.00%
0/3
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
4.8%
2/42
|
0.00%
0/3
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
19.0%
8/42
|
0.00%
0/3
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
11.9%
5/42
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
3/42
|
33.3%
1/3
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
33.3%
1/3
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
33.3%
1/3
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
9.5%
4/42
|
0.00%
0/3
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Investigations
Blood acid phosphatase increased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Investigations
Blood albumin decreased
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Investigations
Blood creatine increased
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Investigations
International normalised ratio increased
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Investigations
Protein total decreased
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Investigations
Weight decreased
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Investigations
Weight increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
6/42
|
33.3%
1/3
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3
|
66.7%
2/3
|
33.3%
1/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3
|
66.7%
2/3
|
100.0%
3/3
|
81.0%
34/42
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3
|
28.6%
12/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3
|
19.0%
8/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
6/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
66.7%
2/3
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
9.5%
4/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
3/42
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
11.9%
5/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
21.4%
9/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
9.5%
4/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
9.5%
4/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
7/42
|
66.7%
2/3
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
33.3%
1/3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
6/42
|
33.3%
1/3
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
33.3%
1/3
|
33.3%
1/3
|
66.7%
2/3
|
11.9%
5/42
|
0.00%
0/3
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.9%
5/42
|
0.00%
0/3
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Nervous system disorders
Parosmia
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
33.3%
1/3
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
9.5%
4/42
|
0.00%
0/3
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
2.4%
1/42
|
33.3%
1/3
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
4.8%
2/42
|
0.00%
0/3
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Renal and urinary disorders
Urinary incontinence
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
33.3%
1/3
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Testicular atrophy
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
14.3%
6/42
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
19.0%
8/42
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
11.9%
5/42
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
7.1%
3/42
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
2.4%
1/42
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
9.5%
4/42
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
2.4%
1/42
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
2.4%
1/42
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Vascular disorders
Flushing
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/42
|
0.00%
0/3
|
|
Vascular disorders
Hot flush
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
14.3%
6/42
|
0.00%
0/3
|
|
Vascular disorders
Hypertension
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
35.7%
15/42
|
66.7%
2/3
|
Additional Information
Senior Director, Clinical Research
Janssen R & D
Phone: (310) 943-8040
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60