A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
Running, not enrolling · Phase 1
Conditions studied: Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT02123758
- Run by
- Aragon Pharmaceuticals, Inc.
- People needed
- 57
- Starts
- 2014-07-09
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.
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
Where it is running
- Study site — Los Angeles, California, United States
- Study site — San Francisco, California, United States
- Study site — Houston, Texas, United States
- Study site — Vancouver, British Columbia, Canada
- Study site — Montreal, Quebec, Canada
- Study site — Rotterdam, Netherlands
- Study site — Sutton, United Kingdom
Full record on ClinicalTrials.gov
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