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New drug combo aims to fight Hard-to-Treat prostate cancer

NCT ID NCT02123758

Disease control Sponsor: Aragon Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests a new drug called JNJ-56021927 combined with abiraterone acetate (Zytiga) and prednisone in 57 men with metastatic castration-resistant prostate cancer. The goal is to see how these drugs interact, check safety, and get an early look at effectiveness. All participants take the drugs by mouth daily for up to 18 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JNJ-56021927 (ARN-509) combined with abiraterone acetate and prednisone
What this could lead to
If successful, this could lead to a more effective treatment option for men with metastatic castration-resistant prostate cancer.
What could go wrong
This is an early phase 1 trial with only 57 participants, so results are preliminary. The combination may cause side effects or not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

57 people

The number who actually took part.

Started

Jul 2014

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer prostate neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration resistant prostate cancer Prostatic neoplasms

Contacts and locations

Locations

  • 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

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