19 results
The primary objective of this study is to evaluate whether adding intensive local anti-inflammatory therapy (Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon dilatation reduces…
Primary:Dual-agent dose escalation part (Part 1):• To determine the maximum tolerated dose of oral, daily (qd) BEZ235 in combination with paclitaxel, qw in patients with advanced solid tumors(MTD1, Arm 1).• To determine the maximum tolerated dose of…
The purpose of this phase I/II is to characterize the safety, tolerability, preliminary activity, pharmacokinetic (PK) and pharmacodynamics (PD) profile of TKI258 administered orally on a 5 days on/2 days off dosing schedule in adult patients with…
Primary: Part 1: Safety and tolerability. Determine the MTD and/or RP2D of MAK683.Part 2: Anti-tumor activity of MAK683.Secondary: Part 1: Anti-tumor activity. Pharmacodynamics (PD). Pharmacokinetics (PK).Part 2: Safety and tolerability. PK, PD.
This trial aims to investigate if peroperative administration of TA can reduce the peroperative and postoperative hemorrhage rates in laparoscopic sleeve gastrectomy.
Primary objective: To estimate the MTD/RDE of LOP628 in solid tumors and AML, respectively.Secondary objectivesL:- To characterize the safety and tolerability of LOP628- To characterize the pharmacokinetic profile of LOP628- To assess emergence of…
* To demonstrate efficacy of budesonide (9 mg budesonide/d) vs. placebo for induction of remission in active incomplete microscopic colitis after 8 weeks of treatment* To study the maintenance of remission after end of treatment* To study safety and…
Primary: To determine the maximum tolerated dose (MTD) and thus the recommended phase IIdose and schedule of single agent oral BGJ398 in patients with advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation.Secundary objectives* to…
Primary:* To assess the efficacy of 2 x 1 mg/d budesonide effervescent tablets vs. placebo for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis (EoE).Secondary:* To study safety and tolerability…
Primary:* To assess the efficacy of a 48-week treatment with 2 x 0.5 mg/d or 2 x 1 mg/d budesonide effervescent tablets vs. placebo for the maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis (EoE).Secondary…
Primary: Phase 1: To estimate the RP2D and/or the MTD for PDR001.Phase II: To estimate the anti-tumor activity of PDR001.Secondary: Both phases: Safety and tolerability, PK profile, emergence of anti-PDR001 antibodies, other parameters for…
Primary: Phase Ib: To estimate the MTD(s) and/or RP2D(s) of the triple combination of WNT974, LGX818 andcetuximab in patients with BRAFV600-mutant CRC harboring Wnt pathway mutations.Phase II: To estimate the preliminary anti-tumor activity of the…
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…
To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.
Primary: Phase I: - To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. To further investigate the safety and tolerability of different doses of…
Secondary objectiveTo assess the safety and tolerability of the investigational treatments in patients with moderate to severe hidradenitis suppurativa (HS) by:• Number and severity of AEs • Physical examination, vital signs, safety laboratory…
Primary: To characterize the safety and tolerability of PDR001 and/or MBG453 in combination with decitabine or azacitidine in relapsed/refractory AML patients, de novo AML patients not candidates for standard induction therapy, or high risk or…
Primary: • Part 1:To evaluate the efficacy of NIR178 and PDR001 combination in patients with selected advanced solid tumors and diffuse large B cell lymphoma (DLBCL). • Part 2: To assess the efficacy of several intermittent dosing schedules of…
This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo metabolic surgery.