15 results
Primary: The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs progression free survival (PFS) compared to treatment with placebo in combination with fulvestrant based on local radiological…
The primary objectives of this study consist of:1. To assess the accuracy of different pulse contour methods to measure CO compared to thermodilution CO measured with a PAC in major abdominal surgery patients.2. To assess the effect of propofol…
Primary: treatment effect of TKI258 in combination with fulvestrant vs. fulvestrant plus placebo on Progression-Free Survival (voor for each of the 2 groups, namely FGF pathway amplified and regardless of FGF pathway amplification status).Secondary…
Previous investigations in our lab have provided insight in the requirements for development of such a system and shown the feasibility of the paradigm (Blokland et al., 2011, Blokland et al., 2012). We have been able to optimize the settings of our…
The aim of this study is to quantify residual ER binding sites during fulvestrant therapy, compared to the tracer uptake prior to fulvestrant therapy.
Primary* To determine the maximum tolerated dose or recommended phase 2 dose of oral BYL719 as single agent and in combination with fulvestrantSecondary* To assess the overall safety and tolerability of BYL719 as single agent and in combination with…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…
To determine effective and safe age specific propofol dosing guidelines for neonates of different age groups (both gestational age and postnatal age). Secondary objective is to determine a new age specific PK/PD (pharmacokinetic/pharmacodynamic),…
The purpose of this studie is to evaluate the bioequivalence of canagliflozin.
1.To evaluate the influence of epidural blockade with ropivacaine on the pharmacokinetics of propofol.2.To evaluate the influence of epidural blockade with ropivacaine on the pharmacodynamics of propofol. This includes both the sedative and the…
The aim of this study is to determine the patients* and endoscopists experiences and patients* safety with different sedation protocols.
Primary ObjectiveThis is a confirmatory trial to establish non-inferior efficacy of remimazolam compared with propofol for induction and maintenance of GA for the purpose of elective surgery in patients classes III and IV based on the American…
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)
Primary: To compare PFS between ribociclib plus fulvestrant to fulvestrant monotherapy (plus placebo) among men and postmenopausal women with HR+, HER2-negative advanced breast cancer who received no or only one prior endocrine treatment for…