14 results
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 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.
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…
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: The primary objective of this prospective clinical trial is to determine the pharmacokinetic variability of SXT (960 mg) in patients receiving TB treatment. With these pharmacokinetic parameters, a population model and limited…
5. Study objective(s) and hypothesis:The aim of this study is to assess the value of early, intensive and efficient treatment of patients with recent acquired arthritis, in preventing progression into destructive RA
In this study we want to assess the hepatic cyst penetration capacity of intravenously administered antibiotics (ciprofloxacin, co-trimoxazole, doxycycline and piperacillin/tazobactam) by comparing blood and cyst fluid concentrations in patients…
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…
The aim of the CO-PRINCE study is to establish the efficacy and safety of long-term antibiotic prophylaxis with co-trimoxazolein children with recurrent upper and/or lower respiratory tract infections (including ear-nose-throat (ENT)).
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…
We hypothesize that treatment of RA can be individualized by taking into account the presence of autoantibodies and quick response to glucocorticoids and JAK inhibitors. Therefore, the aims of this randomized controlled trial are: 1. To compare…
- To assess the effectiveness of rectal culture-guided antimicrobial prophylaxis for transrectal prostate biopsy (random ultrasound-guided, targeted MRI-guided or targeted MRI-ultrasound fusion guided) on infectious complications. - To compare the…
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…
Primary: To determine whether three months of prophylactic treatment with co-trimoxazole causes a reduction in the number of days a child experiences at least two RTI symptoms in children aged 6 months to <=10 years with recurrent RTIs, when…