A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer

NCT ID: NCT01756638

Last Updated: 2017-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-06
• Study Completion Date: 2014-10-17

Brief Summary

The purpose of this study is to investigate safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) and who have not received prior chemotherapy (treatment of disease, usually cancer, by chemical agents).

Detailed Description

This is a multi-center (conducted in more than one center), open-label (all people know the identity of the intervention), single-arm study to investigate safety and efficacy of abiraterone. The study consists of 3 phases: Screening phase (consists of 14 days before study commences on Day -1); Treatment phase (consists of 28-daily dosing cycles wherein abiraterone 1000 milligram [mg] once daily along with 5 mg prednisolone twice daily will be given until disease progression or unacceptable toxicity is observed); and Follow-up phase (up to 5 years or until survival after the first dose of study drug). Abiraterone will be orally administered daily as at least 1 hour before the meal or 2 hours after the meal. Dose reduction will be allowed at the Investigator's discretion but not lower than 500 mg per day. Participants will discontinue study treatment at disease progression unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from abiraterone. Efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 12 weeks of therapy. Participants' safety will be monitored throughout the study.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Abiraterone acetate; JNJ-212082

Study Design

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

Study Groups

Abiraterone plus Prednisolone

Abiraterone 1000 milligram (mg) oral tablets will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Abiraterone

Intervention Type: DRUG

Abiraterone will be administered orally as 1000 milligram (mg) per day for 28-daily dosing cycles which will be continued until disease progression or unacceptable toxicity.

Prednisolone

Intervention Type: DRUG

Prednisolone will be administered orally as 5 mg tablets twice daily for 28-daily dosing cycle which will be continued until disease progression or unacceptable toxicity.

Interventions

Abiraterone

Abiraterone will be administered orally as 1000 milligram (mg) per day for 28-daily dosing cycles which will be continued until disease progression or unacceptable toxicity.

Intervention Type: DRUG

Prednisolone

Prednisolone will be administered orally as 5 mg tablets twice daily for 28-daily dosing cycle which will be continued until disease progression or unacceptable toxicity.

Intervention Type: DRUG

Other Intervention Names

JNJ-212082

Eligibility Criteria

Inclusion Criteria

• In-patients or out-patients with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
• Have surgically or medically castrated, with testosterone levels of less than 50 nanogram per deciliter
• Have prostate-specific antigen (PSA) level of at least 5 nanogram per milliliter
• Be under PSA progression according to Prostate-Specific Antigen Working Group (PSAWG) eligibility criteria or objective progression by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria for participants with measurable disease after androgen deprivation
• Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1

Exclusion Criteria

• Has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels or any systemic corticosteroid within 4 weeks prior to Cycle 1 Day 1 or has received ketoconazole for prostate cancer
• Has received radiotherapy, chemotherapy (including estramustine) or immunotherapy (including provenge) within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1
• Has had surgery or local prostatic intervention within 4 weeks prior to Cycle 1 Day 1. In addition, any clinically relevant sequel from the surgery must have resolved prior to Cycle 1 Day 1
• Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart Association (NYHA) Class 3 to 4 heart disease or cardiac ejection fraction measurement of less than 50 percent within 6 months prior to Cycle 1 Day 1
• Has uncontrolled hypertension (systolic blood pressure greater than or equal to 160 millimeter of mercury or diastolic blood pressure greater than or equal to 95 millimeter of mercury)

• Minimum Eligible Age: 20 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

Asahi, , Japan

Fukuoka, , Japan

Gifu, , Japan

Kanazawa, , Japan

Kashiwa, , Japan

Kita-Gun, , Japan

Kukichūō, , Japan

Kurashiki, , Japan

Maebashi, , Japan

Matsuyama, , Japan

Mitaka, , Japan

Niigata, , Japan

Osaka, , Japan

Ōsaka-sayama, , Japan

Sagamihara, , Japan

Sakura, , Japan

Sapporo, , Japan

Yokohama, , Japan

Yokosuka, , Japan

Countries

Japan

References

Matsubara N, Uemura H, Satoh T, Suzuki H, Nishiyama T, Uemura H, Hashine K, Imanaka K, Ozono S, Akaza H. A phase 2 trial of abiraterone acetate in Japanese men with metastatic castration-resistant prostate cancer and without prior chemotherapy (JPN-201 study). Jpn J Clin Oncol. 2014 Dec;44(12):1216-26. doi: 10.1093/jjco/hyu149. Epub 2014 Oct 15.

Reference Type: DERIVED

PMID: 25320340 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=2412&filename=JNJ-212082-JPN-201-Synopsis.pdf

A Phase 2 Study of JNJ-212082 (abiraterone acetate) in Metastatic Castration-Resistant Prostate Cancer Patients Who Are Chemotherapy-Naive

Other Identifiers

JNJ-212082-JPN-201

Identifier Type: -

Identifier Source: secondary_id

CR017059

Identifier Type: -

Identifier Source: org_study_id