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

Phase 1
18 Years
Not Enrolling
Prostate Neoplasms

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mean plasma concentrations of abiraterone

Outcome Time Frame:

Stage 1 predose Day 1, Days 2-4, Days 8-11; Stage 2 Day 1 Cycles 4, 7, 10

Safety Issue:


Principal Investigator

Cougar Biotechnology Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Cougar Biotechnology, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

July 2007

Completion Date:

March 2012

Related Keywords:

  • Prostate Neoplasms
  • Prostate neoplasms
  • Abiraterone acetate
  • CB7630
  • Prostate cancer
  • Pharmacokinetics
  • Neoplasms
  • Prostatic Neoplasms



Fountain Valley, California  92708