Prostate NeoplasmsPhase 1NCT00600535
A Pharmacokinetics Study to Assess Abiraterone Acetate Capsule and Tablet Formulations in Patients With Prostate Cancer
A Phase 1 study testing Stage 1 Group 1: abiraterone acetate, Stage 1 Group 2: abiraterone acetate and Stage 2: abiraterone acetate in people with Prostate Neoplasms, run by Cougar Biotechnology, Inc. at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Neoplasms
- What is being tested?
- Stage 1 Group 1: abiraterone acetate, Stage 1 Group 2: abiraterone acetate and Stage 2: abiraterone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2007to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Neoplasms
- Being tested
- Stage 1 Group 1: abiraterone acetate, Stage 1 Group 2: abiraterone acetate, Stage 2: abiraterone acetate, Stage 3: abiraterone acetate, Stage 3: glucocorticoid
- Keywords
- Prostate neoplasms, Abiraterone acetate, CB7630, Prostate cancer, Pharmacokinetics
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stage 1 Group 1: abiraterone acetateDrug
1000 mg capsules/day orally on Day 1. On Day 8, patients will crossover and receive tablet formulation at the same dose.
Stage 1 Group 2: abiraterone acetateDrug
1000 mg tablets/day orally on Day 1. On Day 8, patients will crossover and receive capsule formulation at the same dose.
Stage 2: abiraterone acetateDrug
1000 mg tablets/day orally for 12 cycles (28 days/cycle) according to assigned group from Stage 1.
Stage 3: abiraterone acetateDrug
1000 mg tablets/day orally for 12 cycles (28 days/cycle).
Stage 3: glucocorticoidDrug
prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for 12 cycles (28 days/cycle).
Stage 4: abiraterone acetateDrug
1000 mg tablets/day orally for up to 24 cycles (28 days/cycle).
Stage 4: glucocorticoidDrug
prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for up to 24 cycles (28 days/cycle).
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone acetate (non-fasting) | Experimental | Not described Receives: Drug: Stage 1 Group 1: abiraterone acetate; Drug: Stage 1 Group 2: abiraterone acetate; Drug: Stage 2: abiraterone acetate |
| Abiraterone acetate (fasting) | Experimental | Not described Receives: Drug: Stage 1 Group 1: abiraterone acetate; Drug: Stage 1 Group 2: abiraterone acetate; Drug: Stage 2: abiraterone acetate; Drug: Stage 3: abiraterone acetate; Drug: Stage 3: glucocorticoid; Drug: Stage 4: abiraterone acetate; Drug: Stage 4: glucocorticoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean plasma concentrations of abiraterone
Measured: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Maximum plasma concentrations of abiraterone
Measured: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Time to reach the maximum plasma concentration of abiraterone
Measured: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Area under the plasma-concentration-time curve from time 0 to the last quantifiable concentration of abiraterone
Measured: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Area under the plasma-concentration-time curve from time 0 to infinite time of abiraterone
Measured: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Elimination half-life of abiraterone
Measured: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Steady state trough concentration of abiraterone
Measured: Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10
Secondary outcomes (4)
Number of participants affected by an adverse event
Measured: Up to 30 days after the last dose of study medication
Number of patients with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria
Measured: Screening; Stage 1 Day 14; Stages 2-3 Day 1, Cycles 1-12; Stage 4 every 3 cycles past Cycle 12
Number of patients with circulating tumor cells isolated from peripheral blood samples defined by cell counts
Measured: 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
Number of patients with circulating tumor cells isolated from peripheral blood samples defined by molecular characterization
Measured: Screening; Stage 2 Day 1 Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cougar Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cougar Biotechnology Clinical Trial, Study director, Cougar Biotechnology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600535
- Sponsor's protocol ID
- CR016933
- Other IDs
- COU-AA-BE
- Status last verified
- Apr 2013
- First submitted
- 14 Jan 2008
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetics Study to Assess the Oral Administration of CB7630 (Abiraterone Acetate) Capsule Formulation and Tablet Formulation in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00600535
- Acronym / sponsor ID
- CR016933
- Conditions
- Prostate Neoplasms
- Keywords
- Prostate neoplasms, Abiraterone acetate, CB7630, Prostate cancer, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cougar Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abiraterone acetate (non-fasting) | Experimental | Drug: Stage 1 Group 1: abiraterone acetate, Drug: Stage 1 Group 2: abiraterone acetate, Drug: Stage 2: abiraterone acetate |
| Abiraterone acetate (fasting) | Experimental | Drug: Stage 1 Group 1: abiraterone acetate, Drug: Stage 1 Group 2: abiraterone acetate, Drug: Stage 2: abiraterone acetate, Drug: Stage 3: abiraterone acetate, Drug: Stage 3: glucocorticoid, Drug: Stage 4: abiraterone acetate, Drug: Stage 4: glucocorticoid |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stage 1 Group 1: abiraterone acetate1000 mg capsules/day orally on Day 1. On Day 8, patients will crossover and receive tablet formulation at the same dose. | Drug | Abiraterone acetate (fasting), Abiraterone acetate (non-fasting) |
| Stage 1 Group 2: abiraterone acetate1000 mg tablets/day orally on Day 1. On Day 8, patients will crossover and receive capsule formulation at the same dose. | Drug | Abiraterone acetate (fasting), Abiraterone acetate (non-fasting) |
| Stage 2: abiraterone acetate1000 mg tablets/day orally for 12 cycles (28 days/cycle) according to assigned group from Stage 1. | Drug | Abiraterone acetate (fasting), Abiraterone acetate (non-fasting) |
| Stage 3: abiraterone acetate1000 mg tablets/day orally for 12 cycles (28 days/cycle). | Drug | Abiraterone acetate (fasting) |
| Stage 3: glucocorticoidprednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for 12 cycles (28 days/cycle). | Drug | Abiraterone acetate (fasting) |
| Stage 4: abiraterone acetate1000 mg tablets/day orally for up to 24 cycles (28 days/cycle). | Drug | Abiraterone acetate (fasting) |
| Stage 4: glucocorticoidprednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for up to 24 cycles (28 days/cycle). | Drug | Abiraterone acetate (fasting) |
Primary outcome
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
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
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
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
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
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
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
4 secondary outcomes
Number of participants affected by an adverse event
Time frame: Up to 30 days after the last dose of study medication
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
- A Pharmacokinetics Study to Assess the Oral Administration of CB7630 (Abiraterone Acetate) Capsule Formulation and Tablet Formulation in Patients with Prostate CancerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cougar Biotechnology Clinical Trial study director
Cougar Biotechnology, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stage 1 Group 1: abiraterone acetate, Stage 1 Group 2: abiraterone acetate and Stage 2: abiraterone acetate in people with Prostate Neoplasms, run by Cougar Biotechnology, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013.