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Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

NCT01217697 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2017-03-24

No results posted yet for this study

Summary

The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).

Conditions

  • Prostate Neoplasms
  • Genital Neoplasms, Male
  • Urogenital Neoplasms
  • Genital Diseases, Male

Interventions

DRUG

Abiraterone Acetate

Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets once daily.

DRUG

Prednisone\Prednisolone

Participants will receive prednisone 5 mg twice daily as oral tablet OR prednisolone 5 mg (if prednisone is not available).

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Colombia
  • Croatia
  • Czechia
  • Denmark
  • Greece
  • Hong Kong
  • Hungary
  • Indonesia
  • Malaysia
  • Mexico
  • New Zealand
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217697 on ClinicalTrials.gov