Active — Not RecruitingPhase 1

A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer

United States, Canada, Netherlands57 participantsStarted 2014-07-09

Plain-language summary

The purpose of this study is to investigate potential drug-drug interaction (DDI) between JNJ-56021927 and abiraterone acetate and between JNJ-56021927 and prednisone, determine safety of the combination and evaluate in a descriptive manner the efficacy in these participants. It will also, potentially provide dosing recommendations for abiraterone acetate in future studies when combined with JNJ-56021927.

Who can participate

Age range

18 Years – 99 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2 * Histologically or cytologically confirmed adenocarcinoma of the prostate * Documentation of metastatic disease * Prostate cancer progression * Surgically or medically castrated, with testosterone levels of less than (\<) 50 nanogram per deciliter (ng/dL) * Adequate bone marrow and organ function Exclusion Criteria: * Known brain metastases * Pathological finding consistent with small cell carcinoma of the prostate * Administration of an investigational agent within 4 weeks of Treatment Cycle 1, Day 1 * Chemotherapy, or immunotherapy for the treatment of prostate cancer within 4 weeks of Treatment Cycle 1, Day 1 * Therapies that must be discontinued or substituted prior to Treatment Cycle 1, Day 1 include the following: Medications known to lower the seizure threshold; Herbal and non-herbal products that may decrease prostate specific antigen (PSA) levels (that is, saw palmetto, pomegranates or pomegranate juice); Medications known to induce drug metabolizing enzymes such as dexamethasone, rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.; and, potent inhibitors of CYP3A4 or CYP2C8

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24]) of abiraterone

Timeframe: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)

Maximum plasma concentration (Cmax) of abiraterone, prednisone and its metabolite prednisolone

Timeframe: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)

Area Under the Plasma Concentration-time Curve From Time Zero to Time 12 Hours (AUC [0-12]) of prednisone and its metabolite prednisolone

Timeframe: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)

Trial details

NCT IDNCT02123758

SponsorAragon Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06-27

View on ClinicalTrials.gov More Prostatic Neoplasms trials

Plain-language summary

Who can participate

Age range

18 Years – 99 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24]) of abiraterone

Timeframe: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)

Maximum plasma concentration (Cmax) of abiraterone, prednisone and its metabolite prednisolone

Timeframe: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)

Area Under the Plasma Concentration-time Curve From Time Zero to Time 12 Hours (AUC [0-12]) of prednisone and its metabolite prednisolone

Timeframe: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)