Trial Outcomes & Findings for An Observational Study of Continuous Oral Dosing of Abiraterone Acetate in Castration-Resistant Prostate Cancer Patients Evaluating Androgens and Steroid Metabolites in Bone Marrow Plasma (NCT NCT00544440)
NCT ID: NCT00544440
Last Updated: 2014-07-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Baseline (predose Week 1 Day 1) and Week 8
Results posted on
2014-07-17
Participant Flow
Participant milestones
| Measure |
Abiraterone Acetate
Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
57
|
Reasons for withdrawal
| Measure |
Abiraterone Acetate
Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
|
|---|---|
|
Overall Study
Other
|
5
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Subject Non-compliance
|
1
|
|
Overall Study
Progressive Disease
|
47
|
Baseline Characteristics
An Observational Study of Continuous Oral Dosing of Abiraterone Acetate in Castration-Resistant Prostate Cancer Patients Evaluating Androgens and Steroid Metabolites in Bone Marrow Plasma
Baseline characteristics by cohort
| Measure |
Abiraterone Acetate
n=57 Participants
Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
|
|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 8.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (predose Week 1 Day 1) and Week 8Population: Bone marrow aspirates were collected at baseline (predose Week 1 Day 1) in 49 participants and in 44 participants at Week 8.
Outcome measures
| Measure |
Abiraterone Acetate
n=49 Participants
Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
|
|---|---|
|
Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter)
Baseline (predose Week 1 Day 1) (n=49)
|
0 Number of Participants
|
|
Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter)
Week 8 (n=44)
|
0 Number of Participants
|
PRIMARY outcome
Timeframe: Baseline (predose Week 1 Day 1) and Week 8Population: Bone marrow aspirates were collected at baseline (predose Week 1 Day 1) in 49 participants and in 44 participants at Week 8.
Outcome measures
| Measure |
Abiraterone Acetate
n=49 Participants
Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
|
|---|---|
|
Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter)
Baseline (predose Week 1 Day 1) (n=49)
|
2 Number of Participants
|
|
Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter)
Week 8 (n=44)
|
2 Number of Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Since there were too few participants with any detectable bone marrow testosterone, this analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 8Population: Data was reported in individual participant listings but not summarized due to statistical constraints.
Outcome measures
Outcome data not reported
Adverse Events
Abiraterone Acetate
Serious events: 29 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abiraterone Acetate
n=57 participants at risk
Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
3/57
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.5%
2/57
|
|
Cardiac disorders
Acute myocardial infarction
|
1.8%
1/57
|
|
Cardiac disorders
Atrial fibrillation
|
3.5%
2/57
|
|
Cardiac disorders
Myocardial infarction
|
1.8%
1/57
|
|
Cardiac disorders
Myocardial ischaemia
|
1.8%
1/57
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
4/57
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
1/57
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/57
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.5%
2/57
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
1.8%
1/57
|
|
Gastrointestinal disorders
Nausea
|
3.5%
2/57
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.8%
1/57
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/57
|
|
General disorders
Asthenia
|
1.8%
1/57
|
|
General disorders
Disease progression
|
5.3%
3/57
|
|
General disorders
Fatigue
|
5.3%
3/57
|
|
General disorders
Pyrexia
|
1.8%
1/57
|
|
Infections and infestations
Catheter related infection
|
1.8%
1/57
|
|
Infections and infestations
Infection
|
3.5%
2/57
|
|
Infections and infestations
Pneumonia
|
8.8%
5/57
|
|
Infections and infestations
Urinary tract infection
|
3.5%
2/57
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.8%
1/57
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
1/57
|
|
Investigations
Aspartate aminotransferase increased
|
3.5%
2/57
|
|
Investigations
Blood bicarbonate decreased
|
1.8%
1/57
|
|
Investigations
Platelet count decreased
|
1.8%
1/57
|
|
Investigations
Weight decreased
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Anorexia
|
5.3%
3/57
|
|
Metabolism and nutrition disorders
Dehydration
|
3.5%
2/57
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
3/57
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.3%
7/57
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.5%
2/57
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/57
|
|
Nervous system disorders
Cerebral ischaemia
|
1.8%
1/57
|
|
Nervous system disorders
Cognitive disorder
|
1.8%
1/57
|
|
Nervous system disorders
Dizziness
|
1.8%
1/57
|
|
Nervous system disorders
Paraplegia
|
1.8%
1/57
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.8%
1/57
|
|
Nervous system disorders
Speech disorder
|
1.8%
1/57
|
|
Nervous system disorders
Syncope
|
3.5%
2/57
|
|
Psychiatric disorders
Confusional state
|
1.8%
1/57
|
|
Psychiatric disorders
Mood altered
|
1.8%
1/57
|
|
Renal and urinary disorders
Haematuria
|
1.8%
1/57
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.8%
1/57
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.5%
2/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.8%
5/57
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
1/57
|
|
Vascular disorders
Hypertension
|
1.8%
1/57
|
|
Vascular disorders
Hypotension
|
5.3%
3/57
|
|
Vascular disorders
Orthostatic hypotension
|
1.8%
1/57
|
Other adverse events
| Measure |
Abiraterone Acetate
n=57 participants at risk
Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
52.6%
30/57
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.8%
5/57
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.3%
7/57
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.8%
5/57
|
|
Gastrointestinal disorders
Constipation
|
26.3%
15/57
|
|
Gastrointestinal disorders
Diarrhoea
|
22.8%
13/57
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
3/57
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
3/57
|
|
Gastrointestinal disorders
Nausea
|
26.3%
15/57
|
|
Gastrointestinal disorders
Vomiting
|
12.3%
7/57
|
|
General disorders
Fatigue
|
63.2%
36/57
|
|
General disorders
Oedema peripheral
|
35.1%
20/57
|
|
General disorders
Pyrexia
|
8.8%
5/57
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
17.5%
10/57
|
|
Infections and infestations
Urinary tract infection
|
7.0%
4/57
|
|
Injury, poisoning and procedural complications
Contusion
|
21.1%
12/57
|
|
Investigations
Alanine aminotransferase increased
|
19.3%
11/57
|
|
Investigations
Aspartate aminotransferase increased
|
26.3%
15/57
|
|
Investigations
Blood albumin decreased
|
5.3%
3/57
|
|
Investigations
Blood alkaline phosphatase increased
|
63.2%
36/57
|
|
Investigations
Blood bilirubin increased
|
10.5%
6/57
|
|
Investigations
Blood calcium decreased
|
5.3%
3/57
|
|
Investigations
Blood cholesterol increased
|
15.8%
9/57
|
|
Investigations
Blood creatinine increased
|
19.3%
11/57
|
|
Investigations
Blood glucose increased
|
5.3%
3/57
|
|
Investigations
Blood triglycerides increased
|
14.0%
8/57
|
|
Investigations
Platelet count decreased
|
7.0%
4/57
|
|
Investigations
White blood cell count decreased
|
8.8%
5/57
|
|
Metabolism and nutrition disorders
Anorexia
|
19.3%
11/57
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
17.5%
10/57
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
82.5%
47/57
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.8%
5/57
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
28.1%
16/57
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
45.6%
26/57
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
19.3%
11/57
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
8.8%
5/57
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
35.1%
20/57
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
21.1%
12/57
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
21.1%
12/57
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.3%
3/57
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
38.6%
22/57
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.4%
23/57
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
19.3%
11/57
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.0%
4/57
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.5%
6/57
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
17.5%
10/57
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.0%
8/57
|
|
Nervous system disorders
Dizziness
|
14.0%
8/57
|
|
Nervous system disorders
Neuropathy peripheral
|
8.8%
5/57
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.0%
4/57
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
3/57
|
|
Psychiatric disorders
Depression
|
5.3%
3/57
|
|
Psychiatric disorders
Insomnia
|
8.8%
5/57
|
|
Renal and urinary disorders
Pollakiuria
|
7.0%
4/57
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.3%
3/57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
5/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.5%
10/57
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.8%
9/57
|
|
Vascular disorders
Hypertension
|
42.1%
24/57
|
|
Vascular disorders
Hypotension
|
7.0%
4/57
|
Additional Information
Senior Director
Clinical Research, Janssen R&D, 10990 Wilshire Blvd, Suite 1200, Los Angeles, CA 90024
Phone: 310-943-8040
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER