A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Prostate specific antigen (PSA) response rate [ Time Frame: Day 1 of treatment Cycles until the date of first documented PSA progression, lost to follow Up or withdrawn consent, as assessed up to 9 months after the last patient is enrolled ] [ Designated as safety issue: No ]PSA response rate is defined as the number of patients achieving a PSA decline of at least 50% according to the Prostate-Specific Antigen Working Group (PSAWG) criteria.
- Overall survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]Overall survival is defined as the time interval from the date of the first dose to the date of death.
- Time to PSA progression [ Time Frame: up to 15 months ] [ Designated as safety issue: No ]Time to PSA progression will be measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria.
- Objective radiographic response rate (RAD-ORR) [ Time Frame: up to 15 months ] [ Designated as safety issue: No ]The objective radiographic response rate (RAD-ORR) is defined as the proportion of patients with measurable lesions with a complete response (CR) or partial response (PR) based on modified response evaluation criteria in solid tumors (RECIST) criteria.
- Serum testosterone and dehydroepiandrosterone (DHEA) sulfate [ Time Frame: up to 15 months ] [ Designated as safety issue: No ]
- Number of patients with adverse events [ Time Frame: up to 30 days after the last study medication administration. ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|Experimental: Abiraterone actetate and Prednisolone||
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.
Other Name: JNJ-212082Drug: prednisolone
Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.
Other Name: prednisolone
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.
|Korea, Republic of|
|Busan, Korea, Republic of|
|Cheongju-Si, Korea, Republic of|
|Seognam-Si, Kyungki-Do, Korea, Republic of|
|Seoul, Korea, Republic of|
|Taichung City, Taiwan|
|Taoyuan County, Taiwan|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|