NCT00474383

Brief 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 uncontrollably, forming tumors) who have failed taxane (docetaxel)-based chemotherapy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_2

Geographic Reach
2 countries

3 active sites

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

November 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 15, 2013

Completed
Last Updated

May 12, 2014

Status Verified

April 1, 2014

Enrollment Period

4.8 years

First QC Date

May 14, 2007

Results QC Date

May 13, 2013

Last Update Submit

April 10, 2014

Conditions

Prostate Neoplasms

Keywords

Prostate neoplasmsCB7630Abiraterone acetateGlucocorticoidPrednisonePrednisolone

Outcome Measures

Primary Outcomes (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.

    Baseline, Week 12

Secondary Outcomes (7)

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

    Baseline up to Week 12

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

    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)

  • Time to PSA Progression

    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)

  • Duration of PSA Response

    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)

  • Progression Free Survival Time

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

  • +2 more secondary outcomes

Study Arms (1)

Abiraterone acetate

EXPERIMENTAL

Abiraterone 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.

Drug: Abiraterone acetateDrug: Glucocorticoid

Interventions

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.

Abiraterone acetate
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.

Abiraterone acetate

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Sutton, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 21802835DERIVED

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

Results Point of Contact

Title
Senior Director
Organization
Clinical Research, Janssen R&D, 10990 Wilshire Blvd, Suite 1200, Los Angeles, CA 90024.
310-943-8040

Study Officials

  • Cougar Biotechnology, Inc. Clinical Trial

    Cougar Biotechnology, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 16, 2007

Study Start

November 1, 2006

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 12, 2014

Results First Posted

August 15, 2013

Record last verified: 2014-04

Locations

US(2)GB(1)