NCT01664728

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 19, 2013

Status Verified

April 1, 2013

Enrollment Period

1.8 years

First QC Date

August 10, 2012

Last Update Submit

April 18, 2013

Conditions

Prostate Neoplasms

Keywords

Prostate neoplasmsHormone refractory prostate cancerCastration resistant prostate cancerCastration refractory prostate cancerAbiraterone acetateCB7630

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (1)

Abiraterone acetate

EXPERIMENTAL
Drug: Abiraterone acetateDrug: Glucocorticoid

Interventions

Abiraterone acetateDRUG

Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily

Abiraterone acetate
GlucocorticoidDRUG

prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily

Abiraterone acetate

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Sutton, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone AcetateGlucocorticoids

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 14, 2012

Study Start

April 1, 2007

Primary Completion

February 1, 2009

Study Completion

September 1, 2012

Last Updated

April 19, 2013

Record last verified: 2013-04

Locations

GB(1)