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…
To protect children with hiv and children using immune-suppressive medication against hepatitis A and B, and to determine the immunogenicity of the combined hepatitis A and B vaccine in these children.
This first-in-man study will investigate the safety and tolerability as well as establish a recommended dose of INCB081776 as a monotherapy (Part 1) and then in combination with INCMGA00012 (Part 2) in participants with advanced malignancies. During…
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…
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,…