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Prostate cancer drug interaction study aims to improve safety

NCT ID NCT02592317

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study looks at how the experimental drug JNJ-56021927 changes the way the body processes several common medications in men with castration-resistant prostate cancer. About 23 participants will receive the cancer drug along with a cocktail of other drugs to measure how their levels change in the blood. The goal is to understand potential interactions so doctors can prescribe safer combinations in the future.

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

23 people

The number who actually took part.

Started

Feb 2016

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 years and older

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 score of 0, 1, or 2 * Adenocarcinoma of the prostate * Participants with non-metastatic castration-resistant prostate cancer (NM-CRPC) or metastatic castration-resistant prostate cancer (mCRPC), who in the opinion of the investigator may benefit from treatment with JNJ-56021927 * Surgically or medically castrated, with testosterone levels of \<50 nanogram per deciliter (ng/dL) * If the participant is being treated with a gonadotropin-releasing hormone (GnRHa) (ie, participant who has not undergone bilateral orchiectomy), then this therapy must have been initiated at least 4 weeks prior to the Cycle 1 Day 1 visit and must be continued throughout the study * Adequate bone marrow and organ function defined as: Hemoglobin (\>=9.0 g/dL, independent of transfusion or growth factor support within the prior 7 days); Absolute neutrophil count (\>=1000/mm\^3 independent of growth factor support within the prior 7 days); Platelet count (\>=75,000/mm\^3 independent of transfusion or growth factor support within the prior 7 days); Serum albumin (\>=3.0 g/dL); Serum creatinine (\<=1.5\*upper limit of normal (ULN) or calculated creatinine clearance \>=50 mL/min/1.73m\^2); Total bilirubin \[\<1.5\*ULN (participants with Gilbert's Syndrome may be enrolled if the total bilirubin is \<4 mg/dL with predominance of indirect bilirubin \>=80% of total bilirubin\]); Aspartate aminotransferase or alanine aminotransferase (\<=3.0\*ULN); Prothrombin time (PT) or partial thromboplastin time (PTT) or international normalized ratio (INR) (PT \<=15 sec or INR \<=1.2 PTT \<=40 sec). Exclusion Criteria: * Known brain metastases * Chemotherapy or immunotherapy for the treatment of prostate cancer within 4 weeks of the Study Day 15 (Cycle 1 Day 1) visit * Prior treatment with enzalutamide within 8 weeks before first dose of drug probes * Therapies that must be discontinued or substituted prior to study visit Day 1, or must be temporarily interrupted during the course of the study, include the following: a) Medications known to lower the seizure threshold within 4 weeks before Study Day 15 (Cycle 1 Day 1) and b) Medications known to induce or inhibit drug metabolizing enzymes (CYP3A4, CYP2C9, CYP2C19 and CYP2C8) or transporter proteins (P-gp, BRCP, OATP1B1, and OATPB3) * Participant has known allergies, hypersensitivity, or intolerance to any of the study drugs/drug probes or excipients * History of seizure or any condition that may predispose to seizure within 12 months prior to enrollment (Study Day 1); brain arteriovenous malformation; or intercranial masses such as schwannoma or meningioma that is causing edema or mass effect * Participants with poor metabolizer genotype for CYP2C9 (\*2, \*3), or CYP2C19 (\*2, \*3, \*4, \*8)

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

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

Contacts and locations

Locations

  • Study site

    Chisinau, Moldova

  • Study site

    Barcelona, Spain

  • Study site

    Seville, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.