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

• Status: Active, not recruiting
• Trial end date: 2022-10-15
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aragon Pharmaceuticals, Inc.
• Treatments: Abiraterone Acetate; Prednisone

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