64 results
The main objective of this pilot study is to determine the biological impact of treatment with targeted agents at the systemic and local tissue level in relation to toxicity.
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…
To determine the dose limiting toxicity (DLT) and the maximum tolerated dose and recommended dose of the combination of everolimus orally once daily and metformin orally BID to patients with advanced solid tumors.
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 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…
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…
The objective of this study is to determine whether influencing the protein pathway thought to underlie TSC by Everolimus treatment will improve cognitive abilities in these children.
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…
Primary objectivesThe primary objective is to assess the progression-free survival (PFS) of patients who receive bi-monthly rotations of Pazopanib and Everolimus versus patients who receive Pazopanib as a first line treatment. Secondary…
To determine the relation between tumor tissue phosphoproteomic profiles and progression-free survival (PFS) in patients with advanced RCC
PrimaryTo estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced PNET and to assess the predictive probability of success in a…
The primary objective of the study is to evaluate additional safety of RAD001 in patients with MRCC who are intolerant of or whose disease has progressed despite any available prior VEGF receptor tyrosine kinaseinhibitor therapy.
Primary objective: To determine the efficacy of RAD001 in patients with progressive irresectable recurrent or metastatic differentiated thyroid carcinoma Secondary objectives:-To determine maximum percentage of tumor reduction-To describe activity…
Objective: To investigate the safety and efficacy of a therapy consisting Everolimus and corticosteroids maintenance immunosuppressive regime twelve months after renal transplantation in recipients of donor kidney graft on graft function and acute…
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…
To evaluate the efficacy of the dose level/regimen(s) of RAD001recommended from the phase I with HT therapy. This will bebased on the evaluation of overall response rate according toRECIST [Post-Text Supplement 1].
To compare overall survival between RAD001+BSC and placebo+BSC in patients with advanced gastric cancer after progression on prior systemic chemotherapy.
To select targeted treatment based on ex vivo kinase activity inhibition profiles to targeted agents of tumor tissue from patients with advanced cancer for whom no standard treatment is available.
Primary objective: To demonstrate superior renal allograft function in de novo renal transplant recipients after early CNI to everolimus conversion assessed by Glomerular Filtration Rate (eGFR) estimated by the Modification of Diet in Renal Disease…
To evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients at Month 36 post-transplantation.