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Prostate NeoplasmsPhase 2NCT00474383

An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

A Phase 2 study testing Abiraterone acetate and Glucocorticoid in people with Prostate Neoplasms, run by Cougar Biotechnology, Inc. at 3 sites in 2 countries.

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 assess the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer (a disease in which cells in the prostate gland [a gland in the male reproductive system found below the bladder and in front of the rectum] become abnormal and start to grow… 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
47 participants
Where
3 sitesin 2 countries
Study dates
Nov 2006to Aug 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically or cytologically confirmed adenocarcinoma (cancer that begins in cells that line certain internal organs and that have secretory properties) of the prostate, but not with neuroendocrine differentiation or of small cell histology
  • Before chemotherapy for prostate cancer with regimen(s) containing paclitaxel or docetaxel
  • Documented prostate-specific antigen (PSA) progression according to PSA working group eligibility criteria with a PSA greater than 5 nanogram per milliliter (ng/mL)
  • Ongoing androgen deprivation with serum testosterone level of less than 50 nanogram per deciliter (ng/dL)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2 (Karnofsky Performance Status greater than or equal 50 percentage)

Who cannot join

  • Active or uncontrolled autoimmune disease that may require corticosteroid therapy
  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Uncontrolled hypertension
  • 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 (participants 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 before to enrollment and after consultation with a cardiologist to insure that the disease is stable)
  • History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Study site

    New York, New York

  • Study site

    San Francisco, California

Other trials in United States

United Kingdom1 site

  • Study site

    Sutton

Other trials in United Kingdom

About this study

Official title: A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

The purpose of this study is to assess the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer (a disease in which cells in the prostate gland [a gland in the male reproductive system found below the bladder and in front of the rectum] become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane (docetaxel)-based chemotherapy.

Read the detailed description

This is an open-label (all people know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with cancer who have failed taxane (docetaxel)-based chemotherapy. Abiraterone acetate 1000 milligram (mg) tablet or capsule will be administered orally (by mouth), once daily after an overnight fast until disease progression, lack of disease response after six 28-day cycles of treatment, or when unacceptable toxicity is encountered. Participants will be treated for up to 12 cycles. All participants will receive a concurrent low-dose glucocorticoid (such as prednisone 5 mg tablet twice daily/prednisolone 0.5 mg tablet once daily). Treatment will be continued in responding participants until death, or disease progression, or end of the study (which is Week 148). Efficacy will primarily be assessed through prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study. Participants who have completed 12 cycles of abiraterone acetate treatment, and continue to receive clinical benefit from such treatment, will be eligible to enter the extension study. Participants who enter the extension study will continue taking abiraterone acetate at the dose they were receiving at the end of the main study together with low-dose glucocorticoid. Efficacy and safety will be monitored throughout the extension study. Study treatment will end when the patient dies, is lost to follow-up, withdraws informed consent, experiences sustained side-effects, has disease progression, or the sponsor discontinues the extension study. After the end of study visit is completed for the extension study, participants will be followed every 12 weeks for survival for up to 3 years following entry into the extension study.

Being tested
Abiraterone acetate, Glucocorticoid
Keywords
Prostate neoplasms, CB7630, Abiraterone acetate, Glucocorticoid, Prednisone, Prednisolone
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

    Abiraterone acetate 1000 milligram (mg) capsule or tablet will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study.

  • GlucocorticoidDrug

    Prednisone/prednisolone 5 mg tablet orally twice daily/dexamethasone 0.5 mg tablet orally once daily continuously in 28-day cycle up to disease progression, death, or end of study.

Study groups in NCT00474383
Study groupRoleWhat they receive
Abiraterone acetateExperimentalAbiraterone acetate 1000 milligram (mg) tablet or capsule will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Receives: Drug: Abiraterone acetate; Drug: Glucocorticoid

What is being measured

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

  1. Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12

    The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.

    Measured: Baseline, Week 12

Secondary outcomes (7)

  1. Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response

    The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.

    Measured: Baseline up to Week 12

  2. Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)

    The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD.

    Measured: Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle)

  3. Time to PSA Progression

    The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.

    Measured: Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)

  4. Duration of PSA Response

    Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.

    Measured: Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)

  5. Progression Free Survival Time

    Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle)

  6. Overall Survival

    Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death.

    Measured: Baseline until death, or end of study (Week 148)

  7. Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)

    The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair >50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead.

    Measured: Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle)

Timeline

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

  1. First posted16 May 2007 (estimated)
  2. Study startNov 2006
  3. Primary completionAug 2011
  4. Study completionAug 2011

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00474383
Sponsor's protocol ID
CR016915
Other IDs
COU-AA-003, COU-AA-003EXT, NCT01798615
Status last verified
Apr 2014
First submitted
14 May 2007
Last updated
12 May 2014
Data monitoring committee
No

Publications

  • Danila DC, Anand A, Sung CC, Heller G, Leversha MA, Cao L, Lilja H, Molina A, Sawyers CL, Fleisher M, Scher HI. TMPRSS2-ERG status in circulating tumor cells as a predictive biomarker of sensitivity in castration-resistant prostate cancer patients treated with abiraterone acetate. Eur Urol. 2011 Nov;60(5):897-904. doi: 10.1016/j.eururo.2011.07.011. Epub 2011 Jul 14.

    PubMed 21802835

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone acetate and Glucocorticoid in people with Prostate Neoplasms, run by Cougar Biotechnology, Inc. at 3 sites in 2 countries.

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 5 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 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12 (time frame: Baseline, Week 12). 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 NCT00474383, which also lists 1 linked publication.

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 12 May 2014.

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