A Safety and Pharmacokinetics Study of Niraparib Plus Apalutamide in Men With Metastatic Castration-Resistant Prostate Cancer
Summary
The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with apalutamide in men with metastatic castration resistant prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies.
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Prostatic Neoplasms
Intervention
Niraparib, Apalutamide
Location
West Hollywood
California
United States
Status
Not yet recruiting
Source
Janssen Research & Development, LLC
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT02924766
- ClinicalTrials.gov processed this data on October 05, 2016
Published on BioPortfolio: 2016-10-06T00:38:22-0400
Clinical Trials
Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients
A randomized phase II study comparing the sequential use of abiraterone followed after progression by apalutamide with alternating cycles of abiraterone and apalutamide
The purpose of this study is to establish the recommended phase 2 dose (RP2D) of niraparib combination therapies of Part 1 and to evaluate the antitumor activity and safety of niraparib co...
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...
This is a two stage, open label, randomized-sequence, single-crossover Phase 1 study to evaluate the relative bioavailability (BA) of niraparib administered as a tablet formulation compare...
This open-label, non-randomized study will investigate the use of niraparib in patients with tumors known to have mutations in BAP1 and other select DNA double-strand break repair pathway ...
PubMed Articles
A sensitive, specific, selective and rapid LC-ESI-MS/MS method has been developed and validated for the quantification of apalutamide in mice plasma using apalutamide-das an internal standard (I.S.). ...
Apalutamide: First Global Approval.
Apalutamide (Erleada) is a next-generation oral androgen receptor (AR) inhibitor that is being developed by Janssen for the treatment of prostate cancer (PC). It binds directly to the ligand-binding d...
Recent studies have demonstrated that most patients with mucinous prostatic adenocarcinoma may have a better prognosis than those with conventional prostatic adenocarcinoma; however, the mechanism rem...
To investigate the association between metabolic syndrome (MetS) and morphological features of benign prostatic enlargement (BPE), including total prostate volume (TPV), transitional zone volume (TZV)...
Prostatic artery embolization for benign prostatic hyperplasia: a review.
Over the last several years prostate artery embolization (PAE) has been developed as a minimally invasive technique for the treatment of benign prostatic hyperplasia induced lower urinary tract sympto...
Medical and Biotech [MESH] Definitions
Ultrasound, High-intensity Focused, Transrectal
Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).
Prostatic Neoplasms
Tumors or cancer of the PROSTATE.
Prostatic Intraepithelial Neoplasia
A premalignant change arising in the prostatic epithelium, regarded as the most important and most likely precursor of prostatic adenocarcinoma. The neoplasia takes the form of an intra-acinar or ductal proliferation of secretory cells with unequivocal nuclear anaplasia, which corresponds to nuclear grade 2 and 3 invasive prostate cancer.
Estramustine
A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.
Prostatic Neoplasms, Castration-resistant
Tumors or cancer of the PROSTATE which can grow in the presence of low or residual amount of androgen hormones such as TESTOSTERONE.
