8 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
The primary objective of this study is to compare the acute effects of single doses of methadone (5 and 10 mg) and buprenorphine (0.2 and 0.4 mg) with placebo on driving performance and cognition. Secondary objective is to study the pharmacokinetics…
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 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…
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…
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:…
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)