A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Running, not enrolling · Phase 1
Conditions studied: Prostatic Neoplasms
In brief
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).
Key facts
- Study ID
- NCT04577833
- Run by
- Janssen Research & Development, LLC
- People needed
- 136
- Starts
- 2020-11-13
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- START Mountain Region — West Valley City, Utah, United States
- Universitair Ziekenhuis Gent — Ghent, Belgium
- GZA Ziekenhuizen- Campus St Augustinus — Wilrijk, Belgium
- Institut Bergonié, Centre de Lutte Contre le Cancer — Bordeaux, France
- HIA Begin — Saint-Mandé, France
- Arensia Exploratory Medicine 1 — Tbilisi, Georgia
- Arensia Exploratory Medicine — Chisinau, Moldova
- Erasmus MC — Rotterdam, Netherlands
- Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy — Warsaw, Poland
- Hosp Univ Fund Jimenez Diaz — Madrid, Spain
- Hosp Univ Hm Sanchinarro — Madrid, Spain
- Hosp Virgen de La Victoria — Málaga, Spain
- Karolinska Universitetssjukhuset Solna — Stockholm, Sweden
- ARENSIA Exploratory Medicine Unit — Kyiv, Ukraine
- Sir Bobby Robson Unit, Northern Centre for Cancer Care — Newcastle upon Tyne, United Kingdom
Full record on ClinicalTrials.gov
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