5 results
PrimaryTo assess the efficacy of LEE011 compared to placebo in patients with relapsed/refractory teratoma with recent progressionSecondaryTo assess other measures of efficacy of LEE011 compared with placebo To assess safety and tolerability of…
Primary objective: To estimate the difference in anti-proliferative activity of LEE011 600 mg QD and LEE011 400 mg QD in combination with letrozole 2.5 mg QD vs single agent letrozole 2.5 mg QD as measured by changes in Ki-67 levels from baseline to…
The primary objective is to investigate if there is an incremental inhibiting effect on MSNA by increasing dosage valsartan above the presently advised dosage. We hypothesize that there will be a further decrease in MSNA as compared to the MSNA…
Primary objective: Progression free survival (PFS) of treatment with letrozole plus LEE011 compared to treatment with letrozole plus placebo .Secondary objectives: Overall survival (OS), overall response rate (OR), overall clinical benefit rate,…
Among patients under treatment for depression, we will select 140 persons with IMD. In this specific group of patients, we will test whether celecoxib add-on (400 mg/d) is more effective than placebo in the treatment of depression through a 12-week…