NCT04577833Active, not recruitingPhase 1
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 136 (actual)
- First submitted
- 5 Oct 2020
- Start date
- 13 Nov 2020
- Primary completion date
- 15 Oct 2021
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Prostate cancer
- NCT number
- NCT04577833
- EU CT number
- 2023-508150-26-00
- EudraCT number
- 2019-000137-39
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 136
- From 13 Nov 2020 to the primary completion date, 15 Oct 2021
- 14 sites in 11 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.
Other illness
- 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
Other
- Symptomatic brain metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| GZA Ziekenhuizen- Campus St Augustinus Coordinator of this site? Confirm its status | Wilrijk | Belgium | Unknown status |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Institut BERGONIE Centre de Lutte Contre le Cancer Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| HIA Begin Coordinator of this site? Confirm its status | Saint-Mandé | France | Unknown status |
| Sir Bobby Robson Unit, Northern Centre for Cancer Care Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Arensia Exploratory Medicine 1 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| ARENSIA Exploratory Medicine Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Karolinska Universitetssjukhuset Solna Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| ARENSIA Exploratory Medicine Unit Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| START Mountain Region Coordinator of this site? Confirm its status | West Valley City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.