An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001

An Expanded Access Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Completed CB7630 Clinical Study COU-AA-001

The purpose of this study is to provide access to abiraterone acetate for patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment.

Study Overview

• Status: Completed
• Conditions: Prostate Neoplasms
• Intervention / Treatment: Drug: Abiraterone acetate; Drug: Glucocorticoid

Detailed Description

This is an open-label (identity of study drug will be known) extended access study to evaluate the safety and efficacy of continued administration of abiraterone acetate in patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment. Patients will continue with the same dose regimen administered at the end of Study COU-AA-001 and will receive a low-dose glucocorticoid daily. Patients will be followed every 3 months for disease progression and survival for up to 3 years following study entry. Safety will be monitored throughout the study up to 30 days after the last dose of study medication.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Sutton, United Kingdom

Participation Criteria

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:

• Completed 12 cycles of abiraterone acetate under study COU-AA-001
• Last dose of abiraterone acetate within 14 days prior to treatment in this study
• Demonstrates potential to gain clinical benefit with continued abiraterone acetate treatment
• Serum potassium level >=3.5 mmol/L
• Eastern Cooperative Oncology Group Performance Status of <3 (Karnofsky Performance Status >=30%)
• Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
• Uncontrolled hypertension
• Abnormal liver function
• 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)
• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abiraterone acetate	Drug: Abiraterone acetate; Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily; Drug: Glucocorticoid; prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria	Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry
Overall survival	every 3 months up to 3 years after study entry

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	up to 30 days after the last dose of study medication
Time to disease progression	every 3 months up to 3 years after study entry
Time to prostate specific antigen progression	every 3 months up to 3 years after study entry
Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST)	every 3 months up to 3 years after study entry

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Publications and helpful links

Helpful Links

• An Expanded Access Open Label Study of CB7630 (Abiraterone Acetate) in Patients with Advanced Prostate Cancer Who Have Completed CB7630 Clinical Study COU-AA-001

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 13, 2012
• First Posted (Estimate): August 14, 2012

Study Record Updates

• Last Update Posted (Estimate): April 19, 2013
• Last Update Submitted That Met QC Criteria: April 18, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Abiraterone acetate; Prostate neoplasms; CB7630; Hormone refractory prostate cancer; Castration resistant prostate cancer; Castration refractory prostate cancer
• 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: CR016912; COU-AA-001EXT (Other Identifier: Janssen Research & Development, LLC); 2006-006755-12 (EudraCT Number)