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Clinical Trials in the UK / NCT02123758
Active, not recruiting Phase 1

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

NCT02123758 · tracked via the Priya Life Science UK tracker
Sponsor
Aragon Pharmaceuticals, Inc
Phase
Phase 1
Started
2014-07-09
Last updated
2026-09-25

Condition(s) studied

Prostatic NeoplasmsMetastatic Castration-Resistant Prostate Cancer

Investigational drug(s) / intervention(s)

Abiraterone Acetate →Prednisone →JNJ-56021927 →

Abiraterone Acetate: 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).

Prednisone: 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: 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).

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24]) of abiraterone — 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.
  • Maximum plasma concentration (Cmax) of abiraterone, prednisone and its metabolite prednisolone — Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
    The Cmax is the maximum observed plasma concentration.
  • Area Under the Plasma Concentration-time Curve From Time Zero to Time 12 Hours (AUC [0-12]) of prednisone and its metabolite prednisolone — 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.

Trial sites (7)

FacilityCityRegionStatus
— Los Angeles California
— San Francisco California
— Houston Texas
— Vancouver British Columbia
— Montreal Quebec
— Rotterdam Netherlands
— Sutton United Kingdom

On this site

📄 Deltasone (prednisone) drug profile →

More Aragon Pharmaceuticals, Inc. trials in the UK

An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) Active, not recruiting
A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer Active, not recruiting
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC Active, not recruiting
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS Active, not recruiting

Other trials for the same condition

177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer Active, not recruiting
A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer Recruiting
An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) Active, not recruiting
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) Recruiting
A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02123758 on ClinicalTrials.gov ↗ ← All trials in the UK