12 results
To establish the MTD and/or recommended phase II dose of the coadministration of LDE225 and INC424 in patients with MF, who have not previously received therapy with a JAK inhibitor
Primary: To estimate the MTD and/or RDE for each of the following three treatment arms in patients with myelofibrosis.* PIM447 plus ruxolitinib (doublet)* Ribociclib (LEE011) plus ruxolitinib (doublet)* PIM447 plus ruxolitinib and Ribociclib (LEE011…
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
Primary Objective: To investigate the effect of treatment with nebulized rhDNase on pulmonary function in children with asthma and persistent obstructive pulmonary function.Secondary Objectives: To investigate the effect of treatment with nebulized…
Primary objective: * To assess the treatment effect on progression-free survival in patients who receive AUY922 on a once-weekly schedule versus patients who receive docetaxel or irinotecanSecondary Objectives* To estimate the overall survival…
Primary Objective: To investigate the effect of treatment with nebulized rhDNase targeted to the peripheral airways compared to rhDNase targeted to the central airways on FEF75 in children with CF who are on maintenance treatment with rhDNase.…
To evaluate the efficacy of inhaled rhDNase in addition to conventional treatment in children with an atelectasis during mechanical ventilation.
Primary: To compare the efficacy of ruxolitinib versus Investigator*s choice Best Available Therapy (BAT) in patients with grade II-IV steroid refractory- acute graft vs host disease assessed by Overall Response Rate (ORR) at the Day 28.Secondary:…
The purpose of the study intends to assess safety, activity and pharmacokinetics of ruxolitinib treatment with corticosteroids in treatment-naïve and steroid refractory (SR)- acute Graft versus Host Disease (aGvHD) patients aged *28 days to <…
Primary: To compare the efficacy of ruxolitinib versus Investigator*s choice Best Available Therapy (BAT) in patients with moderate or severe SR-cGvHD assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 visit.Secondary: To compare the rate…
To assess the rate of complete response (CR) in Grades III and IV SR-aGVHD participants on Day 28 postrandomization.
To characterize the safety, tolerability, and recommended phase 2 dose (RP2D) of each combination partner used with ruxolitinib (Part 1)To evaluate the preliminary efficacy of each novel ruxolitinib combination treatment arm (Parts 2 & 3)