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

NCT ID: NCT02123758

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-09
• Study Completion Date: 2027-12-31

Brief 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.

Detailed Description

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.

Conditions

Prostatic Neoplasms; Metastatic Castration-Resistant Prostate Cancer

Study Design

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

Study Groups

Cohort 1

Participants will receive abiraterone acetate (AA) along with prednisone on Day 1, Treatment Cycle 1 up to Day 7, Treatment Cycle 1; followed by combined intake of abiraterone acetate + prednisone (AAP) + JNJ-56021927 from Day 8, Treatment Cycle 1 up to the end of treatment (EoT) visit (ie, up to approximately 18 months). On Day 8, Treatment Cycle 2 participants will receive JNJ-56021927, 1 hour after intake of AA and prednisone. Breakfast will be offered approximately 30 minutes after intake of JNJ-56021927. Treatment cycles will be of 28 days.

Group Type: EXPERIMENTAL

Abiraterone Acetate

Intervention Type: 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).

Prednisone

Intervention Type: 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

Intervention Type: 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).

Cohort 2

Participants will receive abiraterone acetate (AA) along with prednisone on Day 1, Treatment Cycle 1 up to Day 7, Treatment Cycle 1; followed by combined intake of AAP + JNJ-56021927 from Day 8, Treatment Cycle 1 up to the end of treatment (EoT) visit (ie, up to approximately 18 months). On Days 7 and 36, participants will receive AA and prednisone together. On Day 8, Treatment Cycle 2 participants will receive JNJ-56021927, 1 hour after intake of AAP. Treatment cycles will be of 28 days.

Group Type: EXPERIMENTAL

Abiraterone Acetate

Intervention Type: 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).

Prednisone

Intervention Type: 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

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

Other Intervention Names

ZYTIGA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Aragon Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aragon Pharmaceuticals, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Aragon Pharmaceuticals, Inc.

Locations

Los Angeles, California, United States

San Francisco, California, United States

Houston, Texas, United States

Vancouver, British Columbia, Canada

Montreal, Quebec, Canada

Rotterdam, , Netherlands

Sutton, , United Kingdom

Countries

United States; Canada; Netherlands; United Kingdom

Other Identifiers

56021927PCR1010

Identifier Type: OTHER

Identifier Source: secondary_id

2014-001426-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR104358

Identifier Type: -

Identifier Source: org_study_id