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

NCT ID: NCT01685983

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-30
• Study Completion Date: 2018-03-06

Brief 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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abiraterone actetate and Prednisolone

Group Type: EXPERIMENTAL

Abiraterone acetate

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Prednisolone

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

Intervention Type: DRUG

Other Intervention Names

JNJ-212082

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Busan, , South Korea

Cheongju-si, , South Korea

Seongnam-Si, Gyeonggi-Do, , South Korea

Seoul, , South Korea

Kaohsiung City, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Taoyuan, , Taiwan

Countries

South Korea; Taiwan

Other Identifiers

212082PCR2007

Identifier Type: OTHER

Identifier Source: secondary_id

CR100009

Identifier Type: -

Identifier Source: org_study_id