A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Protocol # :
Prostatic Neoplasms
Disease Sites
Principal Investigator
Smith, Matthew, R.
Site Investigator
Bubley, Glenn
Pomerantz, Mark, M.
Site Research Nurses
Gundy, Kathryn, E.
Gurski, Carol
Leisner, Claire
Markt, Denise, A.
Walsh, Meghara

Trial Description

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of
niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and
deoxyribonucleic acid (DNA) repair anomalies.

Eligibility Requirements

Inclusion Criteria:

- Histologically confirmed prostate cancer (mixed histology is acceptable, with the
exception of the small cell pure phenotype, which is excluded)

- Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer
with evidence of disease progression on or after treatment, or discontinued from a
taxane-based chemotherapy due to an adverse event

- Received a second-generation or later androgen receptor (AR)-targeted therapy (for
example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the
treatment of metastatic prostate cancer with evidence of disease progression or
non-metastatic castration-resistant prostate cancer with evidence of subsequent

- Biomarker-positive by at least one of the following criteria: (a) Biallelic
deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or
tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test
(somatic local results must be confirmed as positive by the sponsor-validated assay
before dosing)

- Progression of metastatic prostate cancer in the setting of castrate levels of
testosterone or history of bilateral orchiectomy at study entry

Exclusion Criteria:

- Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP)

- Prior platinum-based chemotherapy for the treatment of prostate cancer

- Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid
leukemia (AML)

- Symptomatic or impending cord compression

- Symptomatic brain metastases