NCT02123758

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
20mo left

Started Jul 2014

Longer than P75 for phase_1

Geographic Reach
4 countries

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jul 2014Dec 2027

First Submitted

Initial submission to the registry

April 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 9, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2016

Completed
11.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 21, 2014

Last Update Submit

April 9, 2026

Conditions

Prostatic NeoplasmsMetastatic Castration-Resistant Prostate Cancer

Keywords

Prostatic NeoplasmsMetastatic Castration-Resistant Prostate Cancer (mCRPC)Prostate cancerAbiraterone Acetate (ZYTIGA)PrednisoneJNJ-56021927

Outcome Measures

Primary Outcomes (3)

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

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

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

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

    The Cmax is the maximum observed plasma concentration.

    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

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

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

Secondary Outcomes (4)

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

    Day 36 (Treatment Cycle 2), on Day 57 (Treatment Cycle 3)

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

    Day 36 (Treatment Cycle 2), on Day 57 (Treatment Cycle 3)

  • Change in prostate specific antigen (PSA)

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

  • Maximal decline in prostate specific antigen (PSA)

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

Study Arms (2)

Cohort 1

EXPERIMENTAL

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.

Drug: Abiraterone AcetateDrug: PrednisoneDrug: JNJ-56021927

Cohort 2

EXPERIMENTAL

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.

Drug: Abiraterone AcetateDrug: PrednisoneDrug: JNJ-56021927

Interventions

PrednisoneDRUG

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).

Cohort 1Cohort 2
Abiraterone AcetateDRUG

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).

Also known as: ZYTIGA
Cohort 1Cohort 2
JNJ-56021927DRUG

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 1Cohort 2

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone AcetatePrednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsPregnadienesPregnanes

Study Officials

  • Aragon Pharmaceuticals, Inc. Clinical Trial

    Aragon Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 28, 2014

Study Start

July 9, 2014

Primary Completion

June 27, 2016

Study Completion (Estimated)

December 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

GB(1)US(3)CA(2)NL(1)