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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01664728
First received: August 10, 2012
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Prostate Neoplasms
Drug: Abiraterone acetate
Drug: Glucocorticoid
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria [ Time Frame: Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: every 3 months up to 3 years after study entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • Time to disease progression [ Time Frame: every 3 months up to 3 years after study entry ] [ Designated as safety issue: No ]
  • Time to prostate specific antigen progression [ Time Frame: every 3 months up to 3 years after study entry ] [ Designated as safety issue: No ]
  • Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: every 3 months up to 3 years after study entry ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: April 2007
Study Completion Date: September 2012
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664728

Locations
United Kingdom
Sutton, United Kingdom
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01664728     History of Changes
Other Study ID Numbers: CR016912, COU-AA-001EXT, 2006-006755-12
Study First Received: August 10, 2012
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Prostate neoplasms
Hormone refractory prostate cancer
Castration resistant prostate cancer
Castration refractory prostate cancer
Abiraterone acetate
CB7630

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014