16 results
Earlier research nas shown the emerging efficacy and safety profile for INC424, which supports further studies in PV subjects who demonstrate resistance or intolerance to HU therapy [Barosi et al.2009]. This pivotal phase III trial (CINC424B2301) is…
Primary Objectives:- To evaluate and compare the overall survival (OS) of subjects with advanced or metastatic adenocarcinoma of the pancreas when treated with JAK 1/2 Inhibitor in combination with capecitabine versus capecitabine alone.Secondary…
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
Optimizing orthotic management in children with cerebral palsy to improve mobility and participation
The primary objective of this study is to evaluate AFO efficacy in children with spastic CP using outcome measures related to ICF the components of *body functions and structures* and *activities and participation*. The secondary aim is to identify…
This study will consist of two parts. In the primary observational part we will assess kinematic and kinetic walking patterns in Duchenne Muscular Dystrophy. Goal is to asses the correlation between progressive contractures and gait patterns. This…
In this study the effectiveness of an ankle-foot orthosis on the walking ability and coordination in patients with Huntington's disease will be evaluated. Subject will be the question of the clinical relevance of wearing an AFO according to…
Primary Objectives:• Part 1: To evaluate the safety and tolerability of ruxolitinib in combination with pemetrexed/cisplatin and select a dose for further evaluation• Part 2: To evaluate and compare the overall survival of subjects with nonsquamous…
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…
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 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 determine whether AFOs optimized for stiffness in patients with calf muscle weakness are superior to standard AFOs in reducing walking effort, as measured by energy cost of walking (ECW, in Jkg-1m-1), and 2) to build a model to predict required…
The objective of this study is the determination of the diagnostic quality (sensitivity, specificity, positive predictive value, negative predictive value) for the detection of malignant or pre-malignant tumor with the DELSENI in comparison with…
To evaluate the added value of nCLE-imaging to conventional bronchoscopic peripheral lung lesion analysis on the diagnostic yield.
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 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)