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A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer

NCT01637402 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-08-17

Study results available
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Summary

The purpose of this study is to find out what effects, good and/or bad,an increased dose of Abiraterone Acetate in combination with prednisone has on patients and their prostate cancer. This study will investigate whether an increased-dose (2,000mg daily) is safe and potentially effective when given to patients whose cancer has grown while taking the standard dose.

Conditions

  • Castration Resistant Prostate Cancer

Interventions

DRUG

Abiraterone Acetate

Standard dose participants: 1,000 mg, once daily, oral administration. Dose escalation participants: 1,000 mg, twice daily, oral administration

DRUG

Prednisone

5 mg, twice daily, oral administration

Sponsors & Collaborators

  • Janssen Biotech, Inc.

    collaborator INDUSTRY

  • Terence Friedlander, MD

    lead OTHER

Principal Investigators

  • Terence Friedlander, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-13
Primary Completion
2017-02-27
Completion
2017-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01637402 on ClinicalTrials.gov