34 results
To determine the efficacy and safety of MEDI4736 evaluated as a single agent or in combination with tremelimumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) whose disease has progressed on 5-FU-containing or gemcitabine-…
- To evaluate the change in cardiac hemodynamics from baseline to 3-month following switch from Flolan to EFI in patients with PAH.- To evaluate the safety and tolerability of switching from Flolan to EFI in patients with PAH.- To evaluate the…
(1) To assess [11C]laniquidar plasma and brain kinetics in healthy volunteer(s), including assessment of the presence of radioactive metabolites in plasma. (2) To develop a tracer kinetic model for [11C]laniquidar in humans. (3) To determine intra-…
Evaluation of the safety and tolerability of Bevacizumab added to standard induction chemotherapy. Evaluation of the effect of Bevacizumab on the CR rate
Comparison of single-dose pharmacokinetics of levetiracetam after rectal versus oral administration at healthy volunteers.
This study evaluates the difference in response to CRT between endocardial en epicardial left ventricular pacing. Secondly, we will evaluate the effect of simulated exercise by means of intravenous dobutamine on response to CRT and device…
To assess safety and tolerability of EFI patients with PAH.
The primary objective is to assess safety and efficacy of abiraterone acetate plus prednisone and abiraterone acetate plus prednisone plus exemestane, each compared with exemestane alone, in postmenopausal women with ER+ metastatic breast cancer…
In this trial will be investigated if a new formulation of valacyclovir, e.g. oral solution, is bioequivalent to valacyclovir tablets. This comparison will be made by determining pharmacokinetic parameters (AUC0-*, Cmax, and tmax) of both…
In this proposed study, we aim to test not only the safety and biodistribution of [68Ga]Sarabesin 3, but also its potential to visualise prostate cancer. If the peptide proves to be successful, a next study will be initiated to test the potential to…
Primary Objectives:*To explore whether early abiraterone exposure (AUC) is corre*lated to treatment response after 3 months and 6 months of therapy (primarily based on radiographic response (RECIST re*sponse: SD, PR, CR) and secondary on…
The main objective of this study is to investigate if the occurrence of cognitive impairment and functional reorganization *defined as increased functional activation in cognitively preserved patients- in MS can be explained by changes in GABA and…
To determine the efficacy (as assessed by rPFS) and safety of olaparib versus investigator choice of enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal…
Determine the efficacy and safety (using objective response rate) of tremelimumab in patients with advanced solid tumors (UBC, PDAC, TNBC).
The objective of the study is to investigate how quickly and to what extent balovaptan is absorbed and eliminated from the body (pharmacokinetics) when it is administered in combination with rifampicin. It will also be investigated to what extent…
The aim of this phase IVI, randomized, open-label study is to compare the efficacy of cabazitaxel versus an AR targeted agent, in patients previously treated with docetaxel and likely to have primary resistance to AR targeted agents.
Primary objective:To determine the equivalent dose of abiraterone when taken with a continental breakfast compared to 1000 mg in fasted stateSecondary objective:To evaluate the preference of the patients: intake of abiraterone with or without food
Primary:Evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in a previous dupilumab asthma study.Secondary:Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous…
To assess the safety and tolerability profile of durvalumab monotherapy, durvalumab + novel oncology therapy, durvalumab + chemotherapy, anddurvalumab + novel oncology therapy + chemotherapy combinations
Primary: To evaluate the efficacy of capmatinib plus pembrolizumab in comparison to pembrolizumab alone. Secondary: * To evaluate the anti-tumor activity of capmatinib plus pembrolizumab in comparison to pembrolizumab alone.* To characterize the…