Evaluating the effects of JNJ-56021927 on drug metabolism in prostate cancer patients
Drug-drug Interaction Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Subjects With Castration-Resistant Prostate Cancer
This study is testing how a new drug called JNJ-56021927 affects how the body processes other medications in men with advanced prostate cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Aragon Pharmaceuticals, Inc. Industry-sponsored |
| Drugs / interventions | Chemotherapy, immunotherapy |
| Locations | 3 sites (Chisinau and 2 other locations) |
| Trial ID | NCT02592317 on ClinicalTrials.gov |
What this trial studies
This Phase 1, multicenter, open-label study aims to assess how multiple doses of JNJ-56021927 influence the pharmacokinetics of various cytochrome P450 enzymes and drug transporters in participants with castration-resistant prostate cancer (CRPC). The study includes a Screening Phase to determine eligibility, followed by a Pretreatment Phase, Treatment Phase, and a Follow-up Phase. It seeks to confirm the in vivo effects of JNJ-56021927 and its active metabolite on drug metabolism, based on previous in vitro findings. Participants will receive JNJ-56021927 along with a drug cocktail that includes pioglitazone and rosuvastatin.
Who should consider this trial
Good fit: Ideal candidates include men with non-metastatic or metastatic castration-resistant prostate cancer who are medically or surgically castrated.
Not a fit: Patients with prostate cancer who are not castrated or have not been on appropriate hormone therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of drug interactions in prostate cancer treatment, potentially leading to more effective therapies.
How similar studies have performed: Other studies have shown promising results in understanding drug metabolism in cancer treatments, but this specific approach with JNJ-56021927 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Chisinau and 2 other locations
- Arensia Exploratory Medicine — Chisinau, Moldova, Republic of (Recruiting)
- Hosp Univ Vall D Hebron — Barcelona, Spain (Completed)
- Hosp. Virgen Del Rocio — Sevilla, Spain (Completed)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.