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Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00887198
First received: April 18, 2009
Last updated: October 2, 2014
Last verified: October 2014

April 18, 2009
October 2, 2014
April 2009
March 2014   (final data collection date for primary outcome measure)
  • Overall Survival [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
  • Radiographic progression-free survival [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
Overall Survival (OS) and Progression-Free Survival [ Time Frame: Every 3 months while on study and during follow up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00887198 on ClinicalTrials.gov Archive Site
  • Time to opiate use for cancer pain [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
  • Time to initiation of cytotoxic chemotherapy [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
  • Time to deterioration in Eastern Cooperative Oncology Group performance score by >=1 point [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
  • Time to prostate-specific antigen progression based on Prostate Cancer Working Group 2 criteria [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
  • Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • Mean plasma concentrations of abiraterone [ Time Frame: Up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]
  • Maximum plasma concentration of abiraterone [ Time Frame: Up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]
  • Time to reach the maximum plasma concentration of abiraterone [ Time Frame: Up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration of abiraterone [ Time Frame: Up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone [ Time Frame: Up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]
  • Elimination half-life [ Time Frame: Up to Cycle 5, Day 1 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
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 phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).

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 throughout the treatment period and safety will be assessed until 30 days after the last dose of abiraterone acetate. throughout the study. Follow-up will continue for up to 60 months (5 years) or until the 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. Patients will be discontinued from long term follow-up at the time of the Clinical Cut-Off Date for Final Analysis (CCO-FA); however, patients still receiving treatment with abiraterone acetate at the CCO-FA will be offered to receive continued treatment for an additional period of up to 3 years or until disease progression or unacceptable toxicity. For these patients, safety assessment will be performed while continuing treatment, and for 30 days after the last dose of abiraterone acetate.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Abiraterone acetate
    1000 mg per day (4 x 250-mg tablets) taken orally.
  • Drug: Placebo
    4 placebo tablets per day taken orally.
  • Drug: Prednisone
    5 mg tablet orally twice daily.
  • Placebo Comparator: Placebo + prednisone
    Placebo plus prednisone
    Interventions:
    • Drug: Placebo
    • Drug: Prednisone
  • Experimental: Abiraterone + prednisone
    Abiraterone acetate plus prednisone
    Interventions:
    • Drug: Abiraterone acetate
    • Drug: Prednisone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1088
May 2017
March 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   France,   Germany,   Greece,   Netherlands,   Spain,   Sweden,   United Kingdom
 
NCT00887198
CR016927, COU-AA-302, 2008-008004-41
Yes
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP