13 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…
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…
The primary objective is to determine the effect on progression-free survival (PFS) of adding MORAb-009 to the combination of pemetrexed and cisplatin in the treatment of subjects with unresectable malignant pleural mesothelioma (MPM). (Protocol ch…
The objective of this study is to investigate the added effect of an intramuscular (IM) gluteal corticosteroid injection above a placebo IM gluteal injection (saline) on pain symptoms in patients with hip OA, not responding satisfactory to the usual…
Scar volume and POSAS score will be measured in the Verapamil group, these will be compared to the scar volume and POSAS score in the Kenacort+Verapamil group and the Kenacort group. In addition, complications/ adverse effects will be reported.
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…
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 objective: to assess whether an intra-muscular gluteal corticosteroid injection is non-inferior to an intra-articular knee corticosteroid injection on knee pain in patients with knee osteoarthritis in general practice at 4 weeks follow-up.…
We will evaluate the clinical and cost-effectiveness of the two guideline recommended treatments for patients with persisting shoulder pain over a 12 month time period. Patients will be randomized to a local corticosteroid injection or referral for…