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A Pharmacokinetics Study to Assess Abiraterone Acetate Capsule and Tablet Formulations in Patients With Prostate Cancer

Primary Purpose

Prostate Neoplasms

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Stage 1 Group 1: abiraterone acetate

Stage 1 Group 2: abiraterone acetate

Stage 2: abiraterone acetate

Stage 3: abiraterone acetate

Stage 3: glucocorticoid

Stage 4: abiraterone acetate

Stage 4: glucocorticoid

About this trial

This is an interventional treatment trial for Prostate Neoplasms focused on measuring Prostate neoplasms, Abiraterone acetate, CB7630, Prostate cancer, Pharmacokinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Abiraterone acetate (non-fasting)

Abiraterone acetate (fasting)

Arm Description

Outcomes

Primary Outcome Measures

Mean plasma concentrations of abiraterone

Maximum plasma concentrations of abiraterone

Time to reach the maximum plasma concentration of abiraterone

Area under the plasma-concentration-time curve from time 0 to the last quantifiable concentration of abiraterone

Area under the plasma-concentration-time curve from time 0 to infinite time of abiraterone

Elimination half-life of abiraterone

Steady state trough concentration of abiraterone

Secondary Outcome Measures

Number of participants affected by an adverse event

Number of patients with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria

Number of patients with circulating tumor cells isolated from peripheral blood samples defined by cell counts

Number of patients with circulating tumor cells isolated from peripheral blood samples defined by molecular characterization

Full Information

NCT ID

NCT00600535

First Posted

January 14, 2008

Last Updated

April 16, 2013

Sponsor

Cougar Biotechnology, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00600535

Brief Title

A Pharmacokinetics Study to Assess Abiraterone Acetate Capsule and Tablet Formulations in Patients With Prostate Cancer

Official Title

A Pharmacokinetics Study to Assess the Oral Administration of CB7630 (Abiraterone Acetate) Capsule Formulation and Tablet Formulation in Patients With Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cougar Biotechnology, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Neoplasms

Keywords

Prostate neoplasms, Abiraterone acetate, CB7630, Prostate cancer, Pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abiraterone acetate (non-fasting)

Arm Type

Experimental

Arm Title

Abiraterone acetate (fasting)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Stage 1 Group 1: abiraterone acetate

Intervention Description

1000 mg capsules/day orally on Day 1. On Day 8, patients will crossover and receive tablet formulation at the same dose.

Intervention Type

Drug

Intervention Name(s)

Stage 1 Group 2: abiraterone acetate

Intervention Description

1000 mg tablets/day orally on Day 1. On Day 8, patients will crossover and receive capsule formulation at the same dose.

Intervention Type

Drug

Intervention Name(s)

Stage 2: abiraterone acetate

Intervention Description

1000 mg tablets/day orally for 12 cycles (28 days/cycle) according to assigned group from Stage 1.

Intervention Type

Drug

Intervention Name(s)

Stage 3: abiraterone acetate

Intervention Description

1000 mg tablets/day orally for 12 cycles (28 days/cycle).

Intervention Type

Drug

Intervention Name(s)

Stage 3: glucocorticoid

Intervention Description

prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for 12 cycles (28 days/cycle).

Intervention Type

Drug

Intervention Name(s)

Stage 4: abiraterone acetate

Intervention Description

1000 mg tablets/day orally for up to 24 cycles (28 days/cycle).

Intervention Type

Drug

Intervention Name(s)

Stage 4: glucocorticoid

Intervention Description

prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for up to 24 cycles (28 days/cycle).

Primary Outcome Measure Information:

Title

Mean plasma concentrations of abiraterone

Time Frame