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Antiandrogen

JNJ-56021927 + Abiraterone for Prostate Cancer

Phase 1

Waitlist Available

Research Sponsored by Aragon Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prostate cancer progression

Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will study the potential side effects and effectiveness of combining two drugs, JNJ-56021927 and abiraterone acetate, in treating prostate cancer.

Who is the study for?

Men with advanced prostate cancer that has spread and is resistant to hormonal therapy can join. They must have low testosterone from treatment, show cancer growth, and have good enough bone marrow and organ function. Men with brain metastases, small cell carcinoma of the prostate, recent other cancer treatments or certain medications are excluded.Check my eligibility

What is being tested?

The trial tests how JNJ-56021927 (ARN-509) interacts with abiraterone acetate and prednisone in treating advanced prostate cancer. It aims to establish safety, observe effectiveness, and may suggest doses for future studies when these drugs are combined.See study design

What are the potential side effects?

Possible side effects include reactions related to hormone levels changes such as fatigue, hot flashes; digestive issues like nausea; potential liver function changes; skin rash; joint pain; and increased blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is getting worse.

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I can take care of myself but might not be able to do heavy physical work.

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My prostate cancer was confirmed by a lab test.

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I have undergone treatment to lower my testosterone below 50 ng/dL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to the end of the treatment phase (approximately 18 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

Secondary outcome measures

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

Change in prostate specific antigen (PSA)

Maximal decline in prostate specific antigen (PSA)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment3 Interventions

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 II: Cohort 1Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JNJ-56021927

2014

Completed Phase 1

~80

Prednisone

2014

Completed Phase 4

~2370