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

Janssen-Cilag International N.V.0 sites100 target enrollmentAugust 17, 2016

Overview

No summary available.

Registry

who.int

Start Date

August 17, 2016

End Date

TBD

Last Updated

9 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).
•5\. At least 1 line of taxane\-based chemotherapy for the treatment of prostate cancer.
•6\. At least 1 line of AR\-targeted therapy (eg, abiraterone acetate, enzalutamide, apalutamide) for prostate cancer.
•7\. Biomarker\-positive sample 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. The PSA level at the screening visit should be \=2 µg/L (2 ng/mL).
•b. Radiographic progression of soft tissue or bone disease by Prostate Cancer
•Working Group 3 (PCWG3\) criteria.

•1\. Prior treatment with a PARP inhibitor.
•2\. Prior platinum\-based chemotherapy.
•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.
•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 radiotherapy \=15 days prior to Cycle 1 Day 1, with the exception of a single fraction of radiotherapy for the purposes of palliation, which is permitted.