16 results
Primary: to estimate progression-free survival in patients treated with everolimus + letrozole in the first line setting.Secondary: overall response rate, clinical benefit rate, overall survival in the first line setting, progression free survival…
To describe and compare pharmacokinetics of everolimus in a 10 mg QD and everolimus 5mg BID schedule, evaluated PK parameters will be a.o. Cmax/Cmin ratio, AUC, Cmax, Cmin, Tmax.
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…
Primary objective: To determine the effect of hyperbilirubinemia on systemic activation of the innate immune response induced by a lipopolysaccharide (LPS) challenge. Secondary Objective(s): - To determine if hyperbilirubinemia shifts the pro-anti…
To compare the combination treatment of everolimus and exemestane to exemestane alone with respect to progression-free survival in postmenopausal women with estrogen receptor positive breast cancer that is refractory to non-steroidal aromatase…
This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time…
Primary objective: to evaluate safety of everolimus in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer that is refractory to NSAIs.Secondary objective: to evaluate adverse events grade 3 and 4 in the…
To evaluate the effects of LCZ696 compared to valsartan on cognitive function over 3 years in patients with HFpEF as assessed by the CogState cognitive assessment battery.
The purpose of this study is to evaluate the efficacy and safety of LCZ696 compared to ramipril, in reducing the occurrence of cardiovascular (CV) death, heart failure (HF) hospitalization and outpatient HF (time-to-first event analysis) in post-AMI…
Primary:- To elucidate the change in physical activity as assessed by the distance walked in meters during the 6-minute walk test between baseline and 12weeks of study drug treatment in sacubitril/valsartan vs. enalapril patients.- To assess changes…
The primary objective:To compare LCZ696 to valsartan in reducing the rate of the composite endpoint of cardiovascular death andtotal (first and recurrent) heart failure (HF) hospitalizations, in HF patients (NYHA Class II-IV) with preserved EF (LVEF…
The primary objective of this study is to assess the safety and tolerability of sacubitril/valsartan compared with standard of care used for treating BP in patients that have been implanted with the HM3 LVAD.
The primary objectives of this study are:- To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NT proBNP from baseline after 12 weeks of treatment in patients with HFpEF.- To demonstrate that LCZ696…
In this side-study proposal we plan to gain more insight in tumor characteristics in order to predict which patients will have a high chance of a long progression-free survival. Study objectives: 1. It is proposed to compare progression-free…
To compare the antiproteinuric effects of sacubitril/valsartan (ARNI) and valsartan (ARB).
MAIN OBJECTIVEDose escalation phase :- To determine the MTD and/or RDE of alpelisib (BYL719) in combination with everolimus, and the MTD and/or RDE of alpelisib in combination with everolimus and exemestaneDose expansion part:- To describe safety…