JNJ-56021927 + Abiraterone for Prostate Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Aragon Pharmaceuticals, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

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.

Inclusion Criteria

My prostate cancer is getting worse.

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

My prostate cancer was confirmed by a lab test.

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

Exclusion Criteria

My prostate cancer is of the small cell type.

I haven't had chemotherapy or immunotherapy for prostate cancer in the last 4 weeks.

I will stop taking certain medications and supplements before starting treatment.

I have cancer that has spread to my brain.

Treatment Details

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.

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.

Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Zytiga for: