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

Janssen-Cilag International N.V.0 sites289 target enrollmentAugust 15, 2016

Overview

No summary available.

Registry

who.int

Start Date

August 15, 2016

End Date

TBD

Last Updated

5 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 to be excluded).
•5\.3\. Criterion modified per Amendment 6
•5\.4\. 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
•6\.4\. Criterion modified per Amendment 7\.
•6\.5\. Received a second\-generation or later 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 metastasis.
•7\.1\. Criterion modified per Amendment 7
•7\.2 Biomarker\-positive by at least one of the following criteria:
•a. Biallelic DNA\-repair anomaly (refer to Table 5\) based on a sponsor\-validated blood or tissue assay.

•1\. Prior treatment with a PARP inhibitor.
•2\. Prior platinum\-based chemotherapy for the treatment of prostrate cancer.
•3\. Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
•4\. Symptomatic or impending cord compression, except if subject has received definitive treatment for this and demonstrates evidence of clinically stable disease.
•5\. Symptomatic brain metastases.
•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 or sponsor, 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.
•9\. Active cancer (other than prostate cancer; or basal cell or squamous cell skin cancer, non\-muscle invasive bladder cancer \[stages pTaG1 and pTaG2], or any other cancer in situ currently in complete remission) within 2 years prior to Cycle 1 Day 1\.
•10\.Prior palliative radiotherapy \=7 days prior to Cycle 1 Day 1 Radiotherapy given \>7 days prior to Cycle 1 Day 1 is permitted as long as any AEs associated with radiotherapy have resolved to Grade 1 or