A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy
A Phase I/II Open Label Study of the 17α-Hydroxylase/ C17,20 Lyase Inhibitor, Abiraterone Acetate in Patients With Prostate Cancer Who Have Failed Hormone Therapy
2 other identifiers
interventional
54
1 country
1
Brief Summary
The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose \[MTD\]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (HRPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2005
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 11, 2007
CompletedFirst Posted
Study publicly available on registry
May 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
August 29, 2013
CompletedMarch 27, 2014
February 1, 2014
3 years
May 11, 2007
June 7, 2013
February 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12
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.
Baseline, Week 12
Secondary Outcomes (5)
Number of Participants With Objective Tumor Response
Baseline up to end of study (1160 days)
Duration of Prostate Specific Antigen (PSA) Response
Baseline up to end of study (1160 days)
Duration of Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Baseline up to end of study (1160 days)
Time to Disease Progression
Baseline up to end of study (1160 days)
Overall Survival
Baseline up to end of study (1160 days)
Other Outcomes (12)
Serum Blood Levels of Testosterone
Baseline, Cycle 2 (within 3 days prior to Day 29)
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Baseline up to 30 days after the last dose of study medication
Serum Blood Levels of Testosterone Precursors
Baseline, Cycle 2 (within 3 days prior to Day 29)
- +9 more other outcomes
Study Arms (1)
Abiraterone acetate
EXPERIMENTALAbiraterone acetate 250 mg up to a maximum of 2000 mg capsules will be given orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants will receive MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg will be given orally (If participants have disease progression) daily up to 12 cycles.
Interventions
Abiraterone 250 mg (1 capsule) up to 2000 mg (8 capsules) once daily, each dose will be tested in sequential order for 28 days to determine the MTD.
Abiraterone acetate MTD orally for 12 cycles (28 day each).
Dexamethasone 0.5 mg orally will be given (If participants have disease progression) daily up to 12 cycles.
Eligibility Criteria
You may qualify if:
- Histologically (pertaining to the disease status of body tissues or cells) documented adenocarcinoma of the prostate, clinically refractory (not responding to treatment) or resistant to hormone therapy, as documented by progression following at least one hormonal therapy
- Prostate specific antigen (PSA) evidence for progressive prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status score equal to 0 or 1
- Life expectancy of greater than or equal to12 week
You may not qualify if:
- Participants with central nervous system (the brain and spinal cord) disease and/or brain metastases
- No currently active second malignancy (cancer or other progressively enlarging and spreading tumor) other than non-melanoma skin cancer
- Myocardial infarction within the 6 months prior to start of study
- No 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 during protocol treatment
- Major surgery or significant traumatic injury within 4 weeks of start of study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Sutton, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Research
- Organization
- Janssen R & D
Study Officials
- STUDY DIRECTOR
Cougar Biotechnology Clinical Trial
Cougar Biotechnology, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2007
First Posted
May 15, 2007
Study Start
November 1, 2005
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
March 27, 2014
Results First Posted
August 29, 2013
Record last verified: 2014-02