14 results
1. To proof local delivery of intravenously administered liposomal glucocorticoids (Nanocort) in subjects with peripheral artery disease by demonstrating Nanocort in atherosclerotic tissue. 2. To determine the differences between cytokine production…
This study is designed to evaluate the effects of short-term liposomal glucocorticoid (Nanocort) infusion on atherosclerotic plaque inflammation in humans measured by 18FDG PET/CT
The primary objective is to evaluate the safety of PEG-liposomal prednisolone sodium phosphate (Nanocort) The secondary objectives of this study are:To explore the efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) To evaluate the…
Primary objective:- To assess the efficacy of niraparib in subjects with measurable mCRPC and who have either biallelic DNA-repair anomalies in BRCA (BRCA 1 and BRCA 2 or germline BRCA. Secondary objectives:- To assess the efficacy of niraparib in…
To demonstrate whether liposomal prednisolone is effective in promoting AVF maturation after surgical creation of a radiocephalic AVF.
To demonstrate that Nanocort is safe and effectively reduces the inflammatory signs and symptoms of active GO.
Primary objective: To assess efficacy and safety (treatment of signs and symptoms) of Nanocort in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation in comparison to a standard of care medication (Depo-Medrol).…
Objectives: The primary objectives of this study are: • Part 1 (dose-escalation): To evaluate the safety of SYD985 in combination with niraparib to determine the maximum tolerated dose (MTD) and recommended combination dose regimen for expansion (…
Primary Objectives:- To determine the BE of a RS FDC tablet formulation of niraparib and Abiraterone Acetate with respect to niraparib and Abiraterone Acetate co-administered as single agents at steady state under modified fasted conditions in…
Primary Objective• To compare the progression free survival (PFS) of programmed death-ligand 1 (PD-L1) positive patients with Stage III or IV high-grade nonmucinous epithelial ovarian cancer treated with platinum-based combination therapy,…
The purpose of this study is to investigate if niraparib added to a standard treatment (consisting of abiraterone acetate plus prednisone) will work better than abiraterone acetate and prednisone alone in treating men with metastatic prostate cancer…
Dual Primary Objectives:• To compare progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) of niraparib plus pembrolizumab versus placebo…
The purpose of this study is to understand if a new treatment for prostate cancer (niraparib) added to a standard treatment (abiraterone acetate plus prednisone) will work better than the standard treatment alone.Cohort 3: the purpose is to evaluate…
Primary objective:Evaulation of safety and tolerability of niraparibExploratory:Evaluation of the efficacy of niraparib relative to placebo as measured by disease-free survival (DFS)Evaluation of distant recurrence-free survival (DRFS)Time to first…