Trial Outcomes & Findings for Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer (NCT NCT01543776)
NCT ID: NCT01543776
Last Updated: 2019-07-05
Results Overview
Data were analyzed on a log scale: log(week 12) - log(baseline) = log ratio. Smaller (more negative) values indicate a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
From baseline to 12 weeks
Results posted on
2019-07-05
Participant Flow
Participant milestones
| Measure |
Arm I (Fasting)
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
abiraterone acetate: Given PO
|
Arm II (Fed)
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
abiraterone acetate: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Arm I (Fasting)
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
abiraterone acetate: Given PO
|
Arm II (Fed)
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
abiraterone acetate: Given PO
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Fasting)
n=36 Participants
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
abiraterone acetate: Given PO
|
Arm II (Fed)
n=36 Participants
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
abiraterone acetate: Given PO
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74 years
n=5 Participants
|
72 years
n=7 Participants
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
26 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to 12 weeksPopulation: Two patients in each arm had missing data at 12 weeks.
Data were analyzed on a log scale: log(week 12) - log(baseline) = log ratio. Smaller (more negative) values indicate a better outcome.
Outcome measures
| Measure |
Arm II (Fed)
n=32 Participants
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
abiraterone acetate: Given PO
|
Arm I (Fasting)
n=32 Participants
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
abiraterone acetate: Given PO
|
|---|---|---|
|
Change in PSA Level
|
-1.59 log ratio
Standard Error 0.27
|
-1.19 log ratio
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Assessed up to 3 yearsTime to PSA progression (25% increase from baseline), radiographic progression, or death.
Outcome measures
| Measure |
Arm II (Fed)
n=34 Participants
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
abiraterone acetate: Given PO
|
Arm I (Fasting)
n=34 Participants
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
abiraterone acetate: Given PO
|
|---|---|---|
|
Progression-free Survival (PFS)
|
8.6 Months
Interval 3.7 to 14.7
|
8.6 Months
Interval 3.6 to 11.0
|
SECONDARY outcome
Timeframe: Cycle 4 (4 months)Population: 29 patients had missing data
Extragonadal serum adrogen
Outcome measures
| Measure |
Arm II (Fed)
n=20 Participants
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
abiraterone acetate: Given PO
|
Arm I (Fasting)
n=19 Participants
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
abiraterone acetate: Given PO
|
|---|---|---|
|
Adrenal Androgen Production (DHEA-S)
|
10.22 microgram per deciliter
Standard Error 1.33
|
13.30 microgram per deciliter
Standard Error 1.47
|
SECONDARY outcome
Timeframe: Assessed up to 1 yearPatients with grade 3 or higher AE (CTCAE Version 4.03)
Outcome measures
| Measure |
Arm II (Fed)
n=34 Participants
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
abiraterone acetate: Given PO
|
Arm I (Fasting)
n=34 Participants
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
abiraterone acetate: Given PO
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
11 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 4 monthsPopulation: Three patients had missing data.
Analyzed on a log scale due to skewness of distribution
Outcome measures
| Measure |
Arm II (Fed)
n=31 Participants
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
abiraterone acetate: Given PO
|
Arm I (Fasting)
n=30 Participants
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
abiraterone acetate: Given PO
|
|---|---|---|
|
Peak Plasma Concentration of Abiraterone
|
4.65 log(ng/mL)
Standard Error 0.21
|
5.39 log(ng/mL)
Standard Error 0.19
|
Adverse Events
Arm I (Fasting)
Serious events: 5 serious events
Other events: 32 other events
Deaths: 6 deaths
Arm II (Fed)
Serious events: 2 serious events
Other events: 32 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Arm I (Fasting)
n=34 participants at risk
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
abiraterone acetate: Given PO
|
Arm II (Fed)
n=34 participants at risk
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
abiraterone acetate: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.9%
1/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
General disorders
Fever
|
2.9%
1/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
General disorders
General disorders and administrative site conditions
|
2.9%
1/34 • 1 year
|
2.9%
1/34 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
1/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
1/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
Infections and infestations
Lung infection
|
5.9%
2/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
Infections and infestations
Sepsis
|
2.9%
1/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.9%
1/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
2.9%
1/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
Infections and infestations
Infections and infestations-other
|
0.00%
0/34 • 1 year
|
2.9%
1/34 • 1 year
|
Other adverse events
| Measure |
Arm I (Fasting)
n=34 participants at risk
Patients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
abiraterone acetate: Given PO
|
Arm II (Fed)
n=34 participants at risk
Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
abiraterone acetate: Given PO
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
11.8%
4/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
8.8%
3/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
17.6%
6/34 • 1 year
|
8.8%
3/34 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
8.8%
3/34 • 1 year
|
14.7%
5/34 • 1 year
|
|
Psychiatric disorders
Anxiety
|
8.8%
3/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
2/34 • 1 year
|
2.9%
1/34 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.9%
2/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
4/34 • 1 year
|
8.8%
3/34 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.8%
3/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
General disorders
Constipation
|
14.7%
5/34 • 1 year
|
8.8%
3/34 • 1 year
|
|
Psychiatric disorders
Depression
|
5.9%
2/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
14.7%
5/34 • 1 year
|
11.8%
4/34 • 1 year
|
|
Nervous system disorders
Dizziness
|
8.8%
3/34 • 1 year
|
11.8%
4/34 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
2/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
2/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
General disorders
Edema limbs
|
14.7%
5/34 • 1 year
|
11.8%
4/34 • 1 year
|
|
General disorders
Fatigue
|
47.1%
16/34 • 1 year
|
47.1%
16/34 • 1 year
|
|
General disorders
Fever
|
5.9%
2/34 • 1 year
|
2.9%
1/34 • 1 year
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • 1 year
|
2.9%
1/34 • 1 year
|
|
Vascular disorders
Hot flashes
|
17.6%
6/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Vascular disorders
Hypertension
|
29.4%
10/34 • 1 year
|
23.5%
8/34 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.9%
2/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.6%
6/34 • 1 year
|
14.7%
5/34 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.7%
5/34 • 1 year
|
20.6%
7/34 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
2/34 • 1 year
|
2.9%
1/34 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.9%
2/34 • 1 year
|
0.00%
0/34 • 1 year
|
|
Infections and infestations
Infections and infestations-Other
|
8.8%
3/34 • 1 year
|
8.8%
3/34 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
2/34 • 1 year
|
2.9%
1/34 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
8.8%
3/34 • 1 year
|
8.8%
3/34 • 1 year
|
|
General disorders
Pain
|
26.5%
9/34 • 1 year
|
44.1%
15/34 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.7%
5/34 • 1 year
|
14.7%
5/34 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
8.8%
3/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/34 • 1 year
|
8.8%
3/34 • 1 year
|
|
General disorders
Chills
|
0.00%
0/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Investigations
Creatinine increased
|
0.00%
0/34 • 1 year
|
8.8%
3/34 • 1 year
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.9%
1/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
General disorders
Localized edema
|
0.00%
0/34 • 1 year
|
11.8%
4/34 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder-Other
|
0.00%
0/34 • 1 year
|
11.8%
4/34 • 1 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.9%
1/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.9%
1/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Investigations
Platelet count decreased
|
2.9%
1/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/34 • 1 year
|
5.9%
2/34 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • 1 year
|
8.8%
3/34 • 1 year
|
|
Investigations
White blood cell decreased
|
2.9%
1/34 • 1 year
|
5.9%
2/34 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60