Clinical Trials in Spain / NCT04577833
Active, not recruiting
Phase 1
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
NCT04577833 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Prostatic Neoplasms
Investigational drug(s) / intervention(s)
Niraparib: Niraparib will be administered orally.
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
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 | Newcastle upon Tyne | United Kingdom |
More Janssen Research & Development, LLC trials in Spain
Other trials for the same condition
Official registry record
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.
View NCT04577833 on ClinicalTrials.gov ↗ ← All trials in Spain