6 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…
To assess the effect of a Roux-en-Y gastric bypass on the pharmacokinetics of a single oral dose of 1000 mg paracetamol
In this study, the main clinical hypothesis is that the TIMI clinically significant bleeding rates will not be different between the rivaroxaban and VKA treatment strategy groups at Month 12.
To assess the effect of a Roux-en-Y gastric bypass on the pharmacokinetics of a single oral dose of 1000 mg paracetamol before the surgery. within one month after the surgery and 6 months after the surgery.
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,…