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Prostate NeoplasmsPhase 1NCT01664728

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

A Phase 1 study testing Abiraterone acetate and Glucocorticoid in people with Prostate Neoplasms, run by Janssen Research & Development, LLC at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Neoplasms
What is being tested?
Abiraterone acetate and Glucocorticoid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2007to Sep 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Study site

    Sutton

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Abiraterone acetate, Glucocorticoid
Keywords
Prostate neoplasms, Hormone refractory prostate cancer, Castration resistant prostate cancer, Castration refractory prostate cancer, Abiraterone acetate, CB7630
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone acetateDrug

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

  • GlucocorticoidDrug

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

Study groups in NCT01664728
Study groupRoleWhat they receive
Abiraterone acetateExperimentalNot described
Receives: Drug: Abiraterone acetate; Drug: Glucocorticoid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria

    Measured: Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry

  2. Overall survival

    Measured: every 3 months up to 3 years after study entry

Secondary outcomes (4)

  1. Number of participants with adverse events

    Measured: up to 30 days after the last dose of study medication

  2. Time to disease progression

    Measured: every 3 months up to 3 years after study entry

  3. Time to prostate specific antigen progression

    Measured: every 3 months up to 3 years after study entry

  4. Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: every 3 months up to 3 years after study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2012 (estimated)
  2. Study startApr 2007
  3. Primary completionFeb 2009
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01664728
Sponsor's protocol ID
CR016912
Other IDs
COU-AA-001EXT, 2006-006755-12
Status last verified
Apr 2013
First submitted
10 Aug 2012
Last updated
19 Apr 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abiraterone acetate and Glucocorticoid in people with Prostate Neoplasms, run by Janssen Research & Development, LLC at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01664728.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2013.

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