- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00600535
A Pharmacokinetics Study to Assess Abiraterone Acetate Capsule and Tablet Formulations in Patients With Prostate Cancer
April 16, 2013 updated by: Cougar Biotechnology, Inc.
A Pharmacokinetics Study to Assess the Oral Administration of CB7630 (Abiraterone Acetate) Capsule Formulation and Tablet Formulation in Patients With Prostate Cancer
The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of capsule and tablet formulations of CB7630 (abiraterone acetate) taken with and without food in patients with prostate cancer.
Study Overview
Status
Completed
Conditions
Detailed Description
This is an open-label study (identity of assigned study drug will be known) to evaluate the pharmacokinetics of abiraterone acetate in patients with prostate cancer.
The study will be conducted in 4 stages: Stage 1 will measure blood levels after patients take 1 daily dose of abiraterone tablet or capsule formulations with and without food; Stage 2 will measure blood levels of single daily doses of abiraterone tablet formulation taken with or without food in parallel design until disease progression (up to 12 cycles [28 days per cycle]); Stages 3 and 4 will evaluate the safety and antitumor effects of abiraterone tablet formulation administered with a low dose glucocorticoid in a fasted state for up to 12 months for each stage.
As of Protocol Amendment 4, all patients who have completed 12 cycles of abiraterone acetate treatment and continue to receive clinical benefit from such a treatment will enter Stage 4 and receive abiraterone acetate in a fasted condition with a low-dose glucocorticoid.
Patients will continue in Stage 4 for an additional 24 cycles.
After patients complete the last study visit, they will be followed every 3 months for disease progression and survival for up to 3 years.
Serial pharmacokinetic samples will be collected during Stages 1 and 2. Efficacy and safety will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 1
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
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Glasgow, United Kingdom
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Sutton, United Kingdom
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California
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Los Angeles, California, United States
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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:
- Men with histologically, cytologically, or biochemically confirmed adenocarcinoma of the prostate
- On-going androgen deprivation with serum testosterone <50 ng/dL (<2.0nmol/L)
- Serum potassium >=3.5 mmol/L
- Eastern Cooperative Oncology Group (ECOG) Performance Status score <2 (Karnofsky Performance Status >=50%)
- No history of adrenal insufficiency or hyperaldosteronism
- Any acute toxicities of prior chemotherapy, radiotherapy have resolved to a NCI CTCAE (version 3.0) grade of <=1 (chemotherapy induced alopecia and grade 2 neuropathy are excluded from this consideration)
- No radiotherapy, chemotherapy, or immunotherapy within 30 days of administration of the study drug 1 (SD1) on Day 1
- No surgery or local prostatic intervention within 28 days of the first dose (any clinically relevant sequelae from the surgery must have resolved prior to SD1 on Day 1)
- Agrees to protocol-defined use of effective contraception
- Life expectancy >12 weeks
Exclusion Criteria:
- Active or uncontrolled autoimmune disease that may require corticosteroid therapy
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- Uncontrolled hypertension
- Protocol-defined laboratory values
- Clinically significant heart disease as evidenced by a myocardial infarction in the past 12 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease (patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least 2 years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable)
- Other malignancy within the previous 5-years other than basal cell or squamous cell carcinomas of skin with a >30% probability of recurrence within 12 months
- History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication
- Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Abiraterone acetate (non-fasting)
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1000 mg capsules/day orally on Day 1.
On Day 8, patients will crossover and receive tablet formulation at the same dose.
1000 mg tablets/day orally on Day 1.
On Day 8, patients will crossover and receive capsule formulation at the same dose.
1000 mg tablets/day orally for 12 cycles (28 days/cycle) according to assigned group from Stage 1.
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Experimental: Abiraterone acetate (fasting)
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1000 mg capsules/day orally on Day 1.
On Day 8, patients will crossover and receive tablet formulation at the same dose.
1000 mg tablets/day orally on Day 1.
On Day 8, patients will crossover and receive capsule formulation at the same dose.
1000 mg tablets/day orally for 12 cycles (28 days/cycle) according to assigned group from Stage 1.
1000 mg tablets/day orally for 12 cycles (28 days/cycle).
prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for 12 cycles (28 days/cycle).
1000 mg tablets/day orally for up to 24 cycles (28 days/cycle).
prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for up to 24 cycles (28 days/cycle).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Mean plasma concentrations of abiraterone
Time Frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Maximum plasma concentrations of abiraterone
Time Frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Time to reach the maximum plasma concentration of abiraterone
Time Frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Area under the plasma-concentration-time curve from time 0 to the last quantifiable concentration of abiraterone
Time Frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Area under the plasma-concentration-time curve from time 0 to infinite time of abiraterone
Time Frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Elimination half-life of abiraterone
Time Frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Steady state trough concentration of abiraterone
Time Frame: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Number of participants affected by an adverse event
Time Frame: Up to 30 days after the last dose of study medication
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Up to 30 days after the last dose of study medication
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Number of patients with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria
Time Frame: Screening; Stage 1 Day 14; Stages 2-3 Day 1, Cycles 1-12; Stage 4 every 3 cycles past Cycle 12
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Screening; Stage 1 Day 14; Stages 2-3 Day 1, Cycles 1-12; Stage 4 every 3 cycles past Cycle 12
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Number of patients with circulating tumor cells isolated from peripheral blood samples defined by cell counts
Time Frame: Screening; Stage 1 Days 1 and 8; Stage 2 Day 1 Cycless 1, 4, 7, and 10; Stage 4 every 3 cycles past Cycle 12
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Screening; Stage 1 Days 1 and 8; Stage 2 Day 1 Cycless 1, 4, 7, and 10; Stage 4 every 3 cycles past Cycle 12
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Number of patients with circulating tumor cells isolated from peripheral blood samples defined by molecular characterization
Time Frame: Screening; Stage 2 Day 1 Cycle 1
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Screening; Stage 2 Day 1 Cycle 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Cougar Biotechnology Clinical Trial, Cougar Biotechnology, Inc.
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.
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
July 1, 2007
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
January 14, 2008
First Submitted That Met QC Criteria
January 14, 2008
First Posted (Estimate)
January 25, 2008
Study Record Updates
Last Update Posted (Estimate)
April 17, 2013
Last Update Submitted That Met QC Criteria
April 16, 2013
Last Verified
April 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
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Abiraterone Acetate
- Glucocorticoids
Other Study ID Numbers
- CR016933
- COU-AA-BE (Other Identifier: Cougar Biotechnology)
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.
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