11 results
The objectives are:1. the effect of steady state concentrations of voriconazole and fluconazole on the steady-state pharmacokinetics of TMC125,2. the effect of steady-state concentrations of TMC125 on the steady-state pharmacokinetics of…
The objective of this study is to evaluate the concentrations in blood after a single administration of 100 mg TMC125. The various administration formulations will be compared to demonstrate that the formulations can be exchanged. The administration…
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…
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…
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…
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 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…
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 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…
The primary objective of this study is to determine the immune-activating capacity of treatment with pembrolizumab and carboplatin/paclitaxel in the neo-adjuvant setting of primary stage IV ovarian cancer as measured by the alteration in magnitude…
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…