Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments abiraterone acetate, prednisolone
Phase phase 2
Sponsor Janssen Research & Development, LLC
Start date August 2011
End date January 2013
Trial size 82 participants
Trial identifier NCT01685983, 212082PCR2007, CR100009

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
abiraterone acetate JNJ-212082
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.
prednisolone
Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.

Primary Outcomes

Measure
Percentage of Participants With Prostate-specific Antigen (PSA) Response
time frame: Baseline, Month 4

Secondary Outcomes

Measure
Overall Survival
time frame: up to 5 years
Time to PSA Progression
time frame: up to 15 months
Percentage of Participants With Objective Radiographic Response
time frame: up to 15 months
Serum Testosterone
time frame: Baseline up to 15 months
Dehydroepiandrosterone (DHEA) Sulfate
time frame: Baseline up to 15 months
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: up to 15 months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV) - Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria - Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel - Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL - Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment - Eastern Cooperative Oncology Group Performance Status less than or equal to 2 Exclusion Criteria: - Active or uncontrolled autoimmune disease that may require corticosteroid therapy - Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection - Uncontrolled hypertension - Hemoglobin less than or equal to 9.0 g/dL independent of transfusion - Has abnormal liver function tests - Surgery or local prostatic intervention within 30 days of the first dose

Additional Information

Official title A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.
Description This is an open-label (all people know the identity of the intervention), multicenter, single arm (only one treatment group) study to evaluate the efficacy and safety of abiraterone acetate in patients with mCRPC. The study will be divided into screening phase (up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of treatment will be 28 days), and follow-up phase. Approximately 80 patients will be enrolled into this study. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug) assessments will be conducted in this study. Patients will continue to receive abiraterone acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.