Overview

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

Status:
Recruiting
Trial end date:
2024-04-22
Target enrollment:
0
Participant gender:
Male
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Abiraterone Acetate
Niraparib
Prednisone
Criteria
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