11 results
The present study protocol proposes a novel cGMP Enhancing Therapeutic Strategy (cGETS) to 1) enhance plasma levels of cGMP, 2) to increase cGMP-related control of the myocardial response to low dose dobutamine stress testing, 3) to improve…
Primary objectives:- To evaluate the effect of old age (* 70 years) on everolimus pharmacokinetics (AUC0-24hr)- To evaluate the effect of obesity (BMI * 30 kg/m2) on everolimus pharmacokinetics (AUC0-24hr)Secondary objectives:- To evaluate whether…
Primary: To allow continued use of everolimus to patients receiving everolimus in a Novartis-sponsoredstudy which has reached its objectives and who are benefitting from treatment with everolimus as defined in the parent protocolSecondary: To…
Primary objective:Analyze the value of pneumoproteins, everolimus exposure, pulmonary function tests, distinct radiological patterns, baseline patient characteristics and the development of skin toxicity or oral mucositis for the prediction of the…
Primary: To compare the reduction in frequency of partial-onset seizures on each of two trough ranges of everolimus (3-7 ng/mL and 9-15 ng/mL) versus placebo in patients with TSC who are taking one to three AEDs. Key secondary: Ability to completely…
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…
Primary: to evaluate the effect of everolimus with reduced exposure CNI versus MPA with standard exposure CNI on the binary composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50mL/min/1.73m2 at Month 12 post-transplantation.…
Phase Ib:Estimate the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of AEB071 and everolimus combination therapy inpatients with DLBCLPhase II:Assess the preliminary evidence for anti-tumor activity at R2PD for AEB071 and…
The objective of this study is to evaluate the effect of cabozantinib compared with everolimus on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine…
To evaluate the efficacy of pasireotide LAR and everolimus alone or in combination in progressive patients with a well differentiated neuroendocrine tumor of the lung or thymus.
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…