Abiraterone Acetate (AA): Abiraterone Acetate will be administered orally.
Prednisone: Prednisone will be administered orally.
Study summary
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).
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Maximum Observed Analyte Concentration at Steady State (Cmax,ss) of Niraparib and Abiraterone Acetate (AA) [Period 2 and Period 3] — Predose, up to 10 hour post dose Cmax,ss is defined as maximum observed analyte concentration at steady state.
Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours at Steady State (AUC [0-24h],ss) of Niraparib and AA (Period 2 and Period 3) — Predose, up to 24 hours post dose AUC (0-24h),ss is defined as area under the plasma concentration-time curve from time zero to 24 hours at steady state.
Ratio of Individual Cmax,ss Values Between Test and Reference Treatment (Period 2 and Period 3) — Predose, up to 10 hours post dose Ratio of individual Cmax,ss values between test and reference treatment will be assessed.
Ratio of individual AUC (0-24h),ss Values Between Test and Reference Treatment (Period 2 and Period 3) — Predose, up to 24 hours post dose Ratio of individual AUC (0-24h),ss values between test and reference treatment will be assessed.
Trial sites (16)
Facility
City
Region
Status
START Mountain Region
West Valley City
Utah
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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