7 results
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…
The aim of this study is to quantify residual ER binding sites during fulvestrant therapy, compared to the tracer uptake prior to fulvestrant therapy.
1) identifying new predictors of ST, in particular of late and very late ST and drug eluting stent thrombosis2) to observe clinical outcome after an episode of a ST
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 test the suitability of OCT for in vivo imaging of the vascularisation and surrounding tissue of burn wounds and scars.
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…
To identify and define characteristics of ILD on the pCLE and pOCT image of airway wall mucosa and the alveolar compartment and compare this to HRCT imaging and pathology.