Know Cancer

or
forgot password

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer


This is a randomized (individuals will be assigned by chance to study treatments),
double-blind (individuals and study personnel will not know the identity of study
treatments), placebo (an inactive substance that is compared with a drug to test whether the
drug has a real effect in a clinical trial)-controlled study in approximately 1,000
medically or surgically castrated male patients with metastatic CRPC who have shown tumor
progression and are asymptomatic or mildly symptomatic. The study period will consist of
screening, treatment, and follow-up phases. Patients will receive study treatment
(abiraterone acetate or placebo) plus prednisone until radiographic progression of disease
and/or unequivocal clinical progression. Efficacy evaluations will be performed and safety
will be assessed throughout the study. Follow-up will continue for 60 months (5 years) or
until patient dies, is lost to follow-up, or withdraws informed consent.

At the interim analysis of overall survival (OS; 43% of death events), the independent data
monitoring committee (IDMC) reviewed the efficacy and safety data and concluded that all of
the data pointed to a significant advantage for patients in one arm of the study compared
with the other arm thereby unanimously recommending unblinding the study and allowing
crossover from the placebo arm to active therapy. Patients currently receiving placebo will
be offered crossover therapy to abiraterone acetate. Treatment for patients who were
originally randomized to the abiraterone acetate treatment group will not change.


Inclusion Criteria:



- Metastatic castration-resistant prostate cancer (CRPC)

- Previous anti-androgen therapy and progression after withdrawal

- ECOG performance status of either 0 or 1

- Medical or surgical castration with testosterone less than 50 ng/dL

- Life expectancy of at least 6 months

Exclusion Criteria:

- Prior cytotoxic chemotherapy or biologic therapy for CRPC

- Prior ketoconazole for prostate cancer

- Known brain metastasis or visceral organ metastasis

- Use of opiate analgesics for cancer-related pain, including codeine and
dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Up to 60 months

Safety Issue:

No

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC

Authority:

United States: Food and Drug Administration

Study ID:

CR016927

NCT ID:

NCT00887198

Start Date:

April 2009

Completion Date:

December 2014

Related Keywords:

  • Prostate Cancer
  • Abiraterone acetate
  • CB7630
  • CRPC
  • Metastatic castration-resistant prostate cancer
  • hormone refractory prostate cancer
  • Prostatic Neoplasms

Name

Location

New Britain, Connecticut  06052
Alexandria, Minnesota  56308
Albany, Georgia  31701
Great Falls, Montana  59405
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Kansas City, Kansas  66160
Omaha, Nebraska  68114
Metairie, Louisiana  70006
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
Milwaukee, Wisconsin  
Charleston, South Carolina  
Honolulu, Hawaii  96813
Las Vegas, Nevada  89109