A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies - A study to understand the effect of Niraparib in men with end-stage PCA+

JANSSEN CILAG INTERNATIONAL NV0 sites160 target enrollmentJanuary 20, 2022

Overview

No summary available.

Registry

who.int

Start Date

January 20, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•2\. \>18 years of age (or the legal age of consent in the jurisdiction in
•which the study is taking place).
•3\. Signed main study ICF indicating that the subject understands the purpose of, and procedures required for, the study and is willing to participate in the study.
•4\. Histologically confirmed prostate cancer (mixed histology is
•acceptable, with the exception of the small cell pure phenotype, which is be excluded).
•5\. Documented evidence of disease progression while on treatment with at least 1 taxane\-based chemotherapy for prostate cancer
•6\. Documented evidence of disease progression while on treatment with at least 1 AR\-targeted therapy (eg, abiraterone acetate, enzalutamide, apalutamide) for prostate cancer.
•7\. Tumor that is biomarker\- positive for DNA\-repair anomalies.
•8\. Progression of metastatic prostate cancer in the setting of castrate levels of testosterone \=50 ng/dL on a gonadotropin releasing hormone analog (GnRHa), or history of bilateral orchiectomy at study entry defined as having one or more of the following:
•a. PSA progression defined by a minimum of 2 rising PSA levels with an interval of \=1 week between each determination (per Prostate Cancer Working Group 3 \[PCWG3] criteria). The PSA level at the screening visit should be \=2 µg/L (2 ng/mL).

•1\. Prior treatment with a PARP inhibitor.
•2\. Prior platinum\-based chemotherapy for the treatment of prostate cancer.
•3\. Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
•4\. Known symptomatic or impending cord compression, except if subject has received definitive treatment for this and demonstrates evidence of clinically stable disease.
•5\. Known symptomatic uncontrolled brain or leptomeningeal metastases (controlled is defined as CNS disease which has undergone treatment
•\[eg, radiation or surgery] at least 15 days prior to Cycle 1 Day 1\).
•6\. Known allergies, hypersensitivity, or intolerance to niraparib or its excipients (refer to Investigator's Brochure).
•7\. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well\-being) or that could prevent, limit, or confound the
•protocol\-specified assessments.
•8\. Known disorder affecting gastrointestinal absorption.