Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02123758

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Vancouver, British Columbia, Canada

Loading trial locations.

About this study

This is a multicenter, open-label (participants will know the identity of study drug received) study in participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC). The study is a single sequence design (ie, all participants will take abiraterone acetate + prednisone [AAP] once daily on Days 1-7 of Treatment Cycle 1 and then proceed with combined daily intake of AAP+JNJ-56021927 from Treatment Cycle 1, Day 8 through to the end of treatment [ie, for up to an expected duration of approximately 18 months] and will be conducted as two cohorts (group of participant's). The study will consist of a 28-day screening phase to determine eligibility, an open-label treatment phase consisting of 28-day treatment cycles, and a 30-day follow-up phase for collection of adverse events (AE) after last dose of study drug. Participants will have blood samples collected during the study to evaluate pharmacokinetics, safety, and antitumor activity (PSA). Participant safety will also be monitored by the collection of adverse events. Imaging assessments for disease evaluation will be planned at discretion of the Investigator. Once all participants have completed study treatment up to Cycle 3 Day 1, a data cutoff is planned to evaluate the short term safety profile of the combination and to complete the PK analysis up to the cutoff date. All participants will continue on study (ie, to receive treatment) until disease progression, withdrawal of consent, lost to follow-up, or the occurrence of unacceptable toxicity. The end of the study is defined when all participants have completed treatment. Participant's safety will be monitored throughout the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abiraterone Acetate

Drug

Administered orally (by mouth) once daily in morning at a dose of 1000 mg for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).

Other names: ZYTIGA

Prednisone

Drug

Administered orally twice a day at a dose of 5mg for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).

JNJ-56021927

Drug

Administered orally once daily in morning at a dose of 240 mg starting on Day 8, Treatment Cycle 1 for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).

Primary outcomes

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

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

    The AUC (0-24) is area under the plasma concentration-time curve from time zero to time 24 hours.

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

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

    The Cmax is the maximum observed plasma concentration.

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

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

    The AUC (0-12) is area under the plasma concentration-time curve from time zero to time 12 hours.

Secondary outcomes

  1. Area Under the Plasma Concentration Curve (AUC [0- 24h]) of JNJ-56021927 and its metabolite JNJ-56142060

    Time frame: Day 36 (Treatment Cycle 2), on Day 57 (Treatment Cycle 3)

    The AUC (0-24) is area under the plasma concentration-time curve from time zero to time 24 hours.

  2. Maximum plasma concentration (Cmax) of JNJ-56021927 and its metabolite JNJ-56142060

    Time frame: Day 36 (Treatment Cycle 2), on Day 57 (Treatment Cycle 3)

    The Cmax is the maximum observed plasma concentration.

  3. Change in prostate specific antigen (PSA)

    Time frame: Up to the end of the treatment phase (approximately 18 months)

    Prostate-specific antigen (PSA) is a protein produced by cells of the prostate gland.

  4. Maximal decline in prostate specific antigen (PSA)

    Time frame: Up to the end of the treatment phase (approximately 18 months)

    Prostate-specific antigen (PSA) is a protein produced by cells of the prostate gland.

Sponsors and collaborators

Lead sponsor

Aragon Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Drug-Drug Interaction, Safety and Efficacy Study With JNJ-56021927 (ARN-509) and Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer

Important dates

Study start
2014
Primary completion
2016
Study completion
2027
First posted
Apr 28, 2014
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.