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An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00474383
Recruitment Status : Completed
First Posted : May 16, 2007
Results First Posted : August 15, 2013
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
Cougar Biotechnology, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Neoplasms
Interventions Drug: Abiraterone acetate
Drug: Glucocorticoid
Enrollment 47
Recruitment Details The 5 participants in the Extension Study received treatment until they experienced progressive disease.
Pre-assignment Details  
Arm/Group Title Abiraterone Acetate (Main Study) Arbitarone Acetate (Extension)
Hide Arm/Group Description Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily. Participants who received abiraterone acetate 1000 milligram (mg) capsule or tablet orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily in Main study, continued the same treatment until disease progression, death, or end of study (Week 148).
Period Title: Main Study
Started 47 0
Completed 11 0
Not Completed 36 0
Reason Not Completed
Adverse Event             11             0
Symptomatic Deterioration             1             0
Progressive Disease             23             0
Other             1             0
Period Title: Between Main Study and Extension
Started 11 0
Completed 5 0
Not Completed 6 0
Reason Not Completed
Did Not Enter Extension Phase             6             0
Period Title: Extension
Started 0 5
Completed 0 0
Not Completed 0 5
Reason Not Completed
Progressive Disease             0             5
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants
67  (8.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
0
   0.0%
Male
47
 100.0%
1.Primary Outcome
Title Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12
Hide Description The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description:
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.2
(22.7 to 51.5)
2.Secondary Outcome
Title Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response
Hide Description The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description:
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Overall Number of Participants Analyzed 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44.7
(30.2 to 59.9)
3.Secondary Outcome
Title Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD.
Time Frame Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description:
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.1
(10.2 to 48.4)
4.Secondary Outcome
Title Time to PSA Progression
Hide Description The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.
Time Frame Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all the participants who were enrolled into the study.
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description:
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: days
169
(113 to 281)
5.Secondary Outcome
Title Duration of PSA Response
Hide Description Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.
Time Frame Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all the participants who were enrolled into the study.
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description:
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: days
169
(141 to 262)
6.Secondary Outcome
Title Progression Free Survival Time
Hide Description Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description:
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Overall Number of Participants Analyzed 23
Median (95% Confidence Interval)
Unit of Measure: days
457
(163 to 712)
7.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death.
Time Frame Baseline until death, or end of study (Week 148)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all the participants who were enrolled into the study.
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description:
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: days
380
(311 to 457)
8.Secondary Outcome
Title Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)
Hide Description The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair >50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead.
Time Frame Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all the participants who were enrolled into the study.
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description:
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
Baseline, ECOG 0 16
Baseline, ECOG 1 27
Baseline, ECOG 2 4
Best Post-Baseline. ECOG 0 25
Best Post-Baseline. ECOG 1 19
Best Post-Baseline. ECOG 2 3
Time Frame From the first dose of study medication until 30 days after the last dose of study medication
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abiraterone Acetate
Hide Arm/Group Description Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
All-Cause Mortality
Abiraterone Acetate
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Abiraterone Acetate
Affected / at Risk (%)
Total   27/47 (57.45%) 
Blood and lymphatic system disorders   
Anaemia * 1  5/47 (10.64%) 
Disseminated intravascular coagulation * 1  1/47 (2.13%) 
Thrombocytopenia * 1  1/47 (2.13%) 
Cardiac disorders   
Left ventricular dysfunction * 1  1/47 (2.13%) 
Myocardial infarction * 1  1/47 (2.13%) 
Endocrine disorders   
Adrenal insufficiency * 1  2/47 (4.26%) 
Gastrointestinal disorders   
Abdominal discomfort * 1  1/47 (2.13%) 
Ascites * 1  1/47 (2.13%) 
Constipation * 1  2/47 (4.26%) 
Diarrhoea * 1  2/47 (4.26%) 
Nausea * 1  4/47 (8.51%) 
Vomiting * 1  3/47 (6.38%) 
General disorders   
Asthenia * 1  1/47 (2.13%) 
Disease progression * 1  1/47 (2.13%) 
Fatigue * 1  1/47 (2.13%) 
Influenza like illness * 1  1/47 (2.13%) 
Pitting oedema * 1  1/47 (2.13%) 
Pyrexia * 1  1/47 (2.13%) 
Infections and infestations   
Bronchopneumonia * 1  1/47 (2.13%) 
Sepsis * 1  2/47 (4.26%) 
Urinary tract infection * 1  1/47 (2.13%) 
Urosepsis * 1  1/47 (2.13%) 
Injury, poisoning and procedural complications   
Fall * 1  1/47 (2.13%) 
Femur fracture * 1  2/47 (4.26%) 
Humerus fracture * 1  1/47 (2.13%) 
Therapeutic agent toxicity * 1  1/47 (2.13%) 
Investigations   
Transaminases increased * 1  1/47 (2.13%) 
Metabolism and nutrition disorders   
Anorexia * 1  3/47 (6.38%) 
Dehydration * 1  1/47 (2.13%) 
Fluid retention * 1  1/47 (2.13%) 
Hypokalaemia * 1  1/47 (2.13%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/47 (2.13%) 
Back pain * 1  2/47 (4.26%) 
Bone pain * 1  1/47 (2.13%) 
Groin pain * 1  2/47 (4.26%) 
Muscular weakness * 1  1/47 (2.13%) 
Pathological fracture * 1  1/47 (2.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastases to peritoneum * 1  1/47 (2.13%) 
Nervous system disorders   
Peripheral motor neuropathy * 1  1/47 (2.13%) 
Spinal cord compression * 1  2/47 (4.26%) 
Syncope * 1  1/47 (2.13%) 
Renal and urinary disorders   
Renal failure * 1  1/47 (2.13%) 
Reproductive system and breast disorders   
Pelvic pain * 1  1/47 (2.13%) 
Respiratory, thoracic and mediastinal disorders   
Aspiration * 1  1/47 (2.13%) 
Dyspnoea * 1  1/47 (2.13%) 
Pleural effusion * 1  1/47 (2.13%) 
Pneumonitis * 1  1/47 (2.13%) 
Vascular disorders   
Hypertension * 1  1/47 (2.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abiraterone Acetate
Affected / at Risk (%)
Total   46/47 (97.87%) 
Blood and lymphatic system disorders   
Anaemia * 1  9/47 (19.15%) 
Neutropenia * 1  3/47 (6.38%) 
Thrombocytopenia * 1  3/47 (6.38%) 
Gastrointestinal disorders   
Constipation * 1  11/47 (23.40%) 
Diarrhoea * 1  11/47 (23.40%) 
Nausea * 1  10/47 (21.28%) 
Vomiting * 1  10/47 (21.28%) 
General disorders   
Fatigue * 1  25/47 (53.19%) 
Oedema peripheral * 1  13/47 (27.66%) 
Infections and infestations   
Cellulitis * 1  4/47 (8.51%) 
Nasopharyngitis * 1  4/47 (8.51%) 
Tooth infection * 1  3/47 (6.38%) 
Urinary tract infection * 1  8/47 (17.02%) 
Injury, poisoning and procedural complications   
Contusion * 1  3/47 (6.38%) 
Investigations   
Alanine aminotransferase increased * 1  3/47 (6.38%) 
Blood albumin decreased * 1  4/47 (8.51%) 
Blood creatine increased * 1  3/47 (6.38%) 
Blood sodium increased * 1  3/47 (6.38%) 
Weight decreased * 1  3/47 (6.38%) 
Weight increased * 1  6/47 (12.77%) 
White blood cell count decreased * 1  3/47 (6.38%) 
Metabolism and nutrition disorders   
Anorexia * 1  13/47 (27.66%) 
Decreased appetite * 1  4/47 (8.51%) 
Hyperglycaemia * 1  7/47 (14.89%) 
Hypokalaemia * 1  29/47 (61.70%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  14/47 (29.79%) 
Back pain * 1  9/47 (19.15%) 
Bone pain * 1  9/47 (19.15%) 
Groin pain * 1  4/47 (8.51%) 
Muscular weakness * 1  5/47 (10.64%) 
Musculoskeletal chest pain * 1  4/47 (8.51%) 
Musculoskeletal pain * 1  9/47 (19.15%) 
Pain in extremity * 1  6/47 (12.77%) 
Nervous system disorders   
Dizziness * 1  5/47 (10.64%) 
Headache * 1  6/47 (12.77%) 
Hypoaesthesia * 1  3/47 (6.38%) 
Paraesthesia * 1  4/47 (8.51%) 
Psychiatric disorders   
Insomnia * 1  4/47 (8.51%) 
Renal and urinary disorders   
Haematuria * 1  3/47 (6.38%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  7/47 (14.89%) 
Dyspnoea * 1  7/47 (14.89%) 
Productive cough * 1  5/47 (10.64%) 
Vascular disorders   
Hypertension * 1  10/47 (21.28%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Clinical Research, Janssen R&D, 10990 Wilshire Blvd, Suite 1200, Los Angeles, CA 90024.
Phone: 310-943-8040 ext 2917
Layout table for additonal information
Responsible Party: Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00474383    
Obsolete Identifiers: NCT01798615
Other Study ID Numbers: CR016915
COU-AA-003
COU-AA-003EXT
First Submitted: May 14, 2007
First Posted: May 16, 2007
Results First Submitted: May 13, 2013
Results First Posted: August 15, 2013
Last Update Posted: May 12, 2014