- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00485303
An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
June 25, 2013 updated by: Cougar Biotechnology, Inc.
A Phase II Open Label Study of CB7630 (Abiraterone Acetate) and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-label (all people know the identity of the intervention), single-arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy.
Abiraterone acetate oral tablet will be administered as a total dose of 1000 milligram (mg) orally (by mouth) once daily after an overnight fast and prednisone/prednisolone will be administered as 5 mg oral tablet twice daily.
Participants will be enrolled and treated up to 12 cycles (or longer, if they have not progressed and continue to benefit from treatment).
The study will consist of 3 parts: Screening (14 days), Open-label Treatment; and follow-up (up to 60 months).
Participants will be evaluated primarily for prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria.
Participants' safety will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sutton, United Kingdom
- Royal Marsden Hospital
-
Sutton, United Kingdom
-
-
-
-
California
-
Los Angeles, California, United States
-
Los Angeles, California, United States, 90024
- UCLA
-
San Francisco, California, United States
-
San Francisco, California, United States, 94115
- UCSF Comprehensive Cancer Center
-
-
Maryland
-
Baltimore, Maryland, United States
-
Baltimore, Maryland, United States, 21205
- John Hopkins
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, United States
-
Boston, Massachusetts, United States, 02215
- Beth Israel Hospital
-
Boston, Massachusetts, United States, 02114
- Masachussetts General Hospital Cancer Center
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma (malignant epithelial tumor with a glandular organization)of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum), but not with neuroendocrine (specialized neurons that produce hormones, such as neuropeptides or biogenic amines) differentiation or of small cell histology
- Prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for prostate cancer with regimen(s) containing docetaxel
- Documented prostate specific antigen (PSA) progression according to Prostate Specific Antigen Working Group (PSAWG) eligibility criteria with a PSA more than (>) 5 nanogram per milliliter (ng/mL) or objective progression by Response Evaluation Criteria in Solid Tumors (RESIST) criteria
- Ongoing androgen deprivation with serum testosterone less than (<) 50 nanogram per deciliter (ng/dL)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of less than equal to (<=) 2 (Karnofsky Performance Status >= 50 percent)
Exclusion Criteria:
- Active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- Uncontrolled hypertension (high blood pressure)
- Hemoglobin <=9.0 gram per deciliter (g/dL) without growth factor or transfusion support
- Abnormal liver (large organ that helps in many body functions, including digestion, metabolism, and storage of substances) function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Abiraterone
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-days dosing cycle and will be continued until disease progression or unacceptable toxicity.
|
Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity.
Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Prostate Specific Antigen (PSA) Response
Time Frame: Day 1 of each cycle (of 28 days each) up to Cycle 12
|
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
|
Day 1 of each cycle (of 28 days each) up to Cycle 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)
Time Frame: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months
|
The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group [PSAWG] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first.
If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation.
|
Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months
|
Radiographic Progression Free Survival (PFS)
Time Frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
|
The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause.
Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
|
Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
|
Overall Survival (OS)
Time Frame: Every 3 months until death or up to 60 months
|
Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death.
|
Every 3 months until death or up to 60 months
|
Percentage of Participants With Objective Radiographic Response
Time Frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
|
Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0.
The CR is disappearance of all lesions.
The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
|
Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
|
Time to PSA Progression
Time Frame: Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)
|
The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria.
If a PSA progression does not occur, subject will be censored at the last PSA evaluation.
|
Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)
|
Time to Radiographic Progression
Time Frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
|
Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed.
|
Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Time Frame: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months
|
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 percent of waking hours, 3=capable of limited self-care, confined to bed or chair >50 percent of waking hours, 4=completely disabled, not capable of any self-care, totally confined to bed or chair and 5=dead.
|
Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months
|
Percentage of Participants With Clinical Benefit
Time Frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
|
Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status.
|
Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
June 8, 2007
First Submitted That Met QC Criteria
June 8, 2007
First Posted (Estimate)
June 12, 2007
Study Record Updates
Last Update Posted (Estimate)
July 2, 2013
Last Update Submitted That Met QC Criteria
June 25, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Prednisone
- Abiraterone Acetate
Other Study ID Numbers
- CR016921
- COU-AA-004
- 2007-002725-74 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostatic Neoplasms
-
Technische Universität DresdenRecruitingOligometastatic Disease | Prostatic Cancer, Castration-ResistantGermany
-
Australian and New Zealand Urogenital and Prostate...Peter MacCallum Cancer Centre, AustraliaRecruitingCastration Resistant Prostatic CancerAustralia
-
British Columbia Cancer AgencySanofi; Ozmosis Research Inc.UnknownMetastatic Castration-Resistant Prostatic CancerCanada, Australia
-
Janssen Research & Development, LLCCompletedCastration-Resistant Prostatic NeoplasmsCanada, Belgium, United States, Spain, Netherlands, Italy, Russian Federation
-
Universität des SaarlandesRecruitingProstate Cancer Metastatic | Advanced Prostate Carcinoma | Castration Resistant Prostatic CancerGermany
-
Yinghao SunNot yet recruitingCastration-Resistant Prostatic Cancer
-
Institut Claudius RegaudWithdrawnProstatic Cancer, Castration-ResistantFrance
-
University Hospital, GrenobleTerminatedCastration-resistant Prostate CancerFrance
-
Michael Graham PhD, MDUniversity of Iowa; Holden Comprehensive Cancer CenterActive, not recruitingProstate Cancer | Prostatic Neoplasms, Castration-Resistant | Prostatic Neoplasm | Prostatic Cancer Recurrent | Prostatic Cancer MetastaticUnited States
-
Rio de Janeiro State UniversityCompletedProstatic Cancer | Prostatic NeoplasmBrazil
Clinical Trials on Abiraterone acetate
-
Janssen Research & Development, LLCCompleted
-
Cougar Biotechnology, Inc.Completed
-
Cougar Biotechnology, Inc.Completed
-
Cougar Biotechnology, Inc.CompletedProstate NeoplasmsUnited Kingdom, United States
-
Janssen Research & Development, LLCCompletedHealthy ParticipantsUnited States
-
Assistance Publique - Hôpitaux de ParisJanssen, LPCompletedProstate CancerFrance
-
Memorial Sloan Kettering Cancer CenterUniversity of California, Los Angeles; Ferring Pharmaceuticals; Wayne State University and other collaboratorsCompleted
-
Janssen Research & Development, LLCCompleted
-
The Affiliated Hospital of Qingdao UniversityCompletedHealthy VolunteersChina
-
Cougar Biotechnology, Inc.Completed