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

NCT00600535 | Completed Phase 1

• 2 other identifiers: CR016933COU-AA-BE
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 3

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.

Conditions

Prostate Neoplasms

Keywords

Prostate neoplasms; Abiraterone acetate; CB7630; Prostate cancer; Pharmacokinetics

Outcome Measures

Primary Outcomes (7)

• Mean plasma concentrations of abiraterone

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

• Maximum plasma concentrations of abiraterone

  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

  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

  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

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

• Elimination half-life of abiraterone

  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

  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

  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

  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

  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

  Screening; Stage 2 Day 1 Cycle 1

Study Arms (2)

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

Interventions

Stage 1 Group 1: abiraterone acetate DRUG

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

Abiraterone acetate (fasting); Abiraterone acetate (non-fasting)

Stage 1 Group 2: abiraterone acetate DRUG

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

Abiraterone acetate (fasting); Abiraterone acetate (non-fasting)

Stage 2: abiraterone acetate DRUG

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

Abiraterone acetate (fasting); Abiraterone acetate (non-fasting)

Stage 3: abiraterone acetate DRUG

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

Abiraterone acetate (fasting)

Stage 3: glucocorticoid DRUG

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

Abiraterone acetate (fasting)

Stage 4: abiraterone acetate DRUG

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

Abiraterone acetate (fasting)

Stage 4: glucocorticoid DRUG

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

Abiraterone acetate (fasting)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cougar Biotechnology, Inc.: lead

Study Sites (3)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

Sutton, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Cougar Biotechnology Clinical Trial

  Cougar Biotechnology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: July 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

GB (2); US (1)