15 results
Part 1:Primary objective:• To evaluate the PK profile of a single oral dose of ESB1609 jetmilled Form A in plasma and compare this profile with the PK profile of ESB1609 monohydrate Form B with 30% SLS.• To compare the PK profile of different…
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…
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…
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
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: 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…
1) Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating the effect of treatment on ACF number, size and rate of dysplasia, relative to the placebo group. 2) Gain mechanistic insight into the chemopreventive properties of 5-ASA…
To compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight plus budesonide (9mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. To study safety and…
In the Netherlands, approximately 500 patients with FAP have been recognized, who are at high risk for developing duodenal carcinoma. Better insights in the pathogenesis of duodenal cancer and development of chemoprevention strategies are of pivotal…
First, to demonstrate whether UDCA-therapy is effective in reducing total liver volume in PLD patients. Second, we want to assess if UDCA modifies quality of life. Finally, we want to assess safety and tolerability.
The primary objective is to evaluate the effect of UDCA and ezetimibe on cholesterol elimination assessed as total faecal sterol concentration. Secondary objective is to assess the effect of UDCA and ezetimibe on plasma lipid profile/composition.
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:…
This study is designed to provide evidence regarding the prophylactic use of UDCA in preventing symptomatic gallstone disease after RYGB and Sleeve Gastrectomy.
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)