4 results
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…
Our primary objective is to evaluate the effect of perioperative enteral and parenteral nutrition on amino acid profile and cardiomyocytes functioning in the cardiac surgical patient. Our secondary objective is to study the effect of the (par)…
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,…
The primary endpoint is the evaluation of the safety and toxicity of TIL with nivolumab and, thereafter, the safety and toxicity of the combination of PEG-IFNa, nivolumab plus TIL. Safety and toxicity will be evaluated according to CTCAE 4.0…