NCT02123758Active, not recruitingPhase 1
A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
A Drug-Drug Interaction, Safety and Efficacy Study With JNJ-56021927 (ARN-509) and Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 21 Apr 2014
- Start date
- 9 Jul 2014
- Primary completion date
- 27 Jun 2016
- Lead sponsor
- Aragon Pharmaceuticals, Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT02123758
- EudraCT number
- 2014-001426-14
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 57
- From 9 Jul 2014 to the primary completion date, 27 Jun 2016
- 7 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Administration of an investigational agent 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
Other illness
- Chemotherapy, or immunotherapy for the treatment of prostate cancer within 4 weeks of Treatment Cycle 1, Day 1
Other
- Known brain metastases
- Pathological finding consistent with small cell carcinoma of the prostate
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: Male · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| - Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| - Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.