5 results
Primary Objective: The primary objective of the study is to quantitatively determine the pharmacokinetics (absorption, distribution, metabolism, and excretion) of [14C]omacetaxine mepesuccinate and its metabolites in patients with relapsed and/or…
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…
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 use psilocybin as a research tool in order to enhance divergent thinking, and facilitate relative goal-directed versus habitual behaviour during and after drug intoxication, and to assess whether psilocybin will deter a stress…
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,…