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

Prostate Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01664728
• Other study ID #: CR016912
• Secondary ID: COU-AA-001EXT200
• Status: Completed
• Phase: Phase 1
• First received: August 10, 2012
• Last updated: April 18, 2013
• Start date: April 2007
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2012
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Neoplasms
• Prostatic Neoplasms

Intervention

Drug:
• Abiraterone acetate
Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily
• Glucocorticoid
prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Overall survival		every 3 months up to 3 years after study entry	No
Secondary	Number of participants with adverse events		up to 30 days after the last dose of study medication	Yes
Secondary	Time to disease progression		every 3 months up to 3 years after study entry	No
Secondary	Time to prostate specific antigen progression		every 3 months up to 3 years after study entry	No
Secondary	Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST)		every 3 months up to 3 years after study entry	No

External 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