27 results
2.1 Primary objectiveTo assess the rate of no progression (NPR) at 8 weeks following treatment with the combination of gefitinib and fulvestrant in EGFR mutated patients who failed previous treatment with reversible EGFR TKI*s (gefitinib or…
The primary objective of this study is to show bioequivalence between nitisinone oral suspension and nitisinone capsules.Secondary objectives of this study are:- To assess the effect of food on the bioavailability of nitisinone oral suspension.- To…
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…
Objective is to show equivalence with respect to the efficacy of sugammadex in subjects with normal or severely impaired renal function, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.
To investigate the potential of an interaction between 4 mg/kg and 16 mg/kg sugammadex and enoxaparin or UFH on anticoagulant activity in young healthy male volunteers.
Primary Trial Objective:To assess the effect of reversal of neuromuscular blockade with sugammadex 4 mg.kg-1 compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of adjudicated postsurgical events of…
The main aim of the present study is i)To assess whether sugammadex has a positive effect on the post-operative alertness of the patients, and ii) to assess the nature, magnitude and the time of onset of this effect (if any).
The aim of this study is to quantify residual ER binding sites during fulvestrant therapy, compared to the tracer uptake prior to fulvestrant therapy.
The primary purpose of the study is to investigate whether the new 20 mg capsule of Orfadin® (nitisinone) has a similar bioavailability in the body (gives the same concentration in the blood) as two of the marketed capsules of 10 mg. The secundary…
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…
The effect of deep muscle relaxation on the abdominal working space during laparosopy, measured by MRI.
- To establish the relationship between the use of deep neuromuscular blockade (NMB) with low pressure pneumoperitoneum (PNP) and the quality of recovery after RARP.- To establish the relationship between the use of deep neuromuscular blockade (NMB…
Evaluate the efficacy of the ER-antagonist Fulvestrant in women with estrogen receptor positive (ER+) low grade gynecological cancers
The current trial aims to demonstrate that sugammadex is generally safe and effective for reversing both moderate and deep block after rocuronium or vecuronium induced NMB in term neonates and young children.
To assess (i) the effect of partial neuromuscular blockade (NMB; TOF ratio 0.7) induced by low-dose rocuronium on the ventilatory response to isocapnic hypoxia and (ii) the effect of the reversal by sugammadex, neostigmine or placebo in healthy…
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…
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 investigate prospectively how the "TAMRO-profile" performs in a pre-operative treatment setting. In addition we can examine whether the profile is specific for tamoxifen or is predictive for endocrine resistance in general. Also the…
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…
To establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) -with standard pressure pneumoperitoneum- and the early quality of recovery.