MedDataX Logo

A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

NCT ID: NCT04577833

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-13

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Niraparib is an orally available, highly selective poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA is a pro-drug of abiraterone which selectively inhibits the enzyme 17 alpha-hydroxylase/C17,20-lyase (CYP17), that is found in the testes and adrenals (leading to systemic inhibition of testosterone production), as well as in prostate tissues and tumors. The rationale of the study is to investigate the various strengths and formulations of niraparib and AA plus prednisone or prednisolone (P) in metastatic castration resistant prostate cancer (mCRPC) participants with and without homologous recombination repair (HRR) gene alterations. In participants with metastatic prostate cancer, DNA-repair anomalies are found in approximately 15 percent (%) to 20% of tumors. This study consists 4 periods: screening phase (up to 21 days); treatment phase (up to 22 days); extension and long-term extension phases (from day 23 until discontinuation); and post-treatment follow up phase (end of treatment \[EoT\] visit within 30 days after the last dose of study treatment). Total duration of study is up to 1.4 years. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study. Participants safety will be monitored throughout the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostatic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Sequence ABD

Participants will receive single doses of niraparib and abiraterone acetate (AA) using niraparib Formulation 1 as Treatment A in Treatment Period 1, followed by multiple doses of niraparib and AA using niraparib Formulation 2 as Treatment B in Treatment Period 2, followed by multiple doses of niraparib and AA using niraparib Formulation 4 as Treatment D in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AA-prednisone (AAP) or AAP alone.

Group Type EXPERIMENTAL

Niraparib

Intervention Type DRUG

Niraparib will be administered orally.

Abiraterone Acetate (AA)

Intervention Type DRUG

Abiraterone Acetate will be administered orally.

Prednisone

Intervention Type DRUG

Prednisone will be administered orally.

Treatment Sequence ADB

Participants will receive Treatment A in Treatment Period 1 followed by Treatment D in Treatment Period 2, followed by Treatment B in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone.

Group Type EXPERIMENTAL

Niraparib

Intervention Type DRUG

Niraparib will be administered orally.

Abiraterone Acetate (AA)

Intervention Type DRUG

Abiraterone Acetate will be administered orally.

Prednisone

Intervention Type DRUG

Prednisone will be administered orally.

Treatment Sequence CBD

Participants will receive single doses of niraparib and AA using niraparib Formulation 3 as Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment D in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone.

Group Type EXPERIMENTAL

Niraparib

Intervention Type DRUG

Niraparib will be administered orally.

Abiraterone Acetate (AA)

Intervention Type DRUG

Abiraterone Acetate will be administered orally.

Prednisone

Intervention Type DRUG

Prednisone will be administered orally.

Treatment Sequence CDB

Participants will receive Treatment C in Treatment Period 1, followed by Treatment D in Treatment Period 2, followed by Treatment B in Treatment Period 3. From Period 2 onwards and during Extension and Long-term Extension Phases, all participants will continue to receive treatment with niraparib and AAP or AAP alone.

Group Type EXPERIMENTAL

Niraparib

Intervention Type DRUG

Niraparib will be administered orally.

Abiraterone Acetate (AA)

Intervention Type DRUG

Abiraterone Acetate will be administered orally.

Prednisone

Intervention Type DRUG

Prednisone will be administered orally.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Niraparib

Niraparib will be administered orally.

Intervention Type DRUG

Abiraterone Acetate (AA)

Abiraterone Acetate will be administered orally.

Intervention Type DRUG

Prednisone

Prednisone will be administered orally.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Diagnosed with metastatic castration-resistant prostate cancer (mCRPC), who in the opinion of the investigator may benefit from treatment in this study
* Able to continue gonadotropin-releasing hormone analogues (GnRHa) therapy during the study if not surgically castrate (that is, participants who have not undergone bilateral orchiectomy)
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (\<=) 1
* Willing to provide a tumor sample (archival) for determination of homologous recombination repair (HRR) gene alteration status

Exclusion Criteria

* Symptomatic brain metastases
* Prior disease progression during treatment with abiraterone acetate (AA) alone or when combined with a poly adenosine diphosphate (ADP)-ribose polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi related toxicity.
* History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)
* Known allergies, hypersensitivity, or intolerance to niraparib or AA or the corresponding excipients of niraparib/AA
* Any medical condition that would make prednisone/prednisolone use contraindicated
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

START Mountain Region

West Valley City, Utah, United States

Site Status

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status

GZA Ziekenhuizen- Campus St Augustinus

Wilrijk, , Belgium

Site Status

Institut Bergonié, Centre de Lutte Contre le Cancer

Bordeaux, , France

Site Status

HIA Begin

Saint-Mandé, , France

Site Status

Arensia Exploratory Medicine

Tbilisi, , Georgia

Site Status

Arensia Exploratory Medicine

Chisinau, , Moldova

Site Status

Erasmus MC

Rotterdam, , Netherlands

Site Status

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Site Status

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, , Poland

Site Status

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Site Status

Hosp Univ Hm Sanchinarro

Madrid, , Spain

Site Status

Hosp Virgen de La Victoria

Málaga, , Spain

Site Status

Karolinska Universitetssjukhuset Solna

Stockholm, , Sweden

Site Status

ARENSIA Exploratory Medicine Unit

Kyiv, , Ukraine

Site Status

Sir Bobby Robson Unit, Northern Centre for Cancer Care

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Romania Russia United States Belgium France Georgia Moldova Netherlands Poland Spain Sweden Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Yu A, Hazra A, Jiao JJ, Hellemans P, Mitselos A, Tian H, Ruixo JJP, Haddish-Berhane N, Ouellet D, Russu A. Demonstrating Bioequivalence for Two Dose Strengths of Niraparib and Abiraterone Acetate Dual-Action Tablets Versus Single Agents: Utility of Clinical Study Data Supplemented with Modeling and Simulation. Clin Pharmacokinet. 2024 Apr;63(4):511-527. doi: 10.1007/s40262-023-01340-5. Epub 2024 Mar 4.

Reference Type DERIVED
PMID: 38436924 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

67652000PCR1001

Identifier Type: OTHER

Identifier Source: secondary_id

2019-000137-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-508150-26-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR108783

Identifier Type: -

Identifier Source: org_study_id