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A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer

NCT01685983 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2019-03-15

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.

Conditions

Interventions

DRUG

Abiraterone acetate

Type=exact number, unit=mg, number=250, form=tablet, route=oral. Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day.

DRUG

Prednisolone

Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-30
Primary Completion
2013-01-24
Completion
2018-03-06

Countries

  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT01685983 on ClinicalTrials.gov