19 results
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…
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…
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…
Study Objectives:Primary Objective* To determine the safety profile of long-term MLN0002 treatmentResource Utilization and Patient-Reported Outcome Objectives* To determine the effect of long-term MLN0002 treatment on time to major inflammatory…
Primary Objective• To determine the effect of vedolizumab induction treatment on clinical remission at Week 6 in the subgroup of patients defined as having failed tumor necrosis factor alpha (TNFa) antagonist therapy (TNFa subpopulation)Secondary…
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 Objective for the Induction Phase* To determine the effect of MLN0002 induction treatment on clinical response at 6 weeksPrimary Objective for the Maintenance Phase* To determine the effect of MLN0002 maintenance treatment on clinical…
Primary Objective for the Induction Phase* To determine the effect of MLN0002 induction treatment on clinical remission at 6 weeksPrimary Objective for the Maintenance Phase* To determine the effect of MLN0002 maintenance treatment on clinical…
The primary objective of this prospective open label study is to assess the ability of vedolizumab to promote clinical, endoscopic and histological remission in patients with active UC in an 'early' and a 'late' disease…
Primary: To evaluate the effects of multiple subcutaneous (SC) doses of elamipretide on left ventricular end systolic volume (LV ESV) assessed by cardiac Magnetic Resonance Imaging (MRI)Secondary:* To evaluate the safety and tolerability of multiple…
Primary Objectives:To evaluate the proportion of subjects with fistula healing at Week 30 with 2 different dose regimens of vedolizumab IV 300 mg in subjects with perianal fistulizing CD.Secondary Objective:To evaluate fistula healing over a 30-week…
Primary Objective:To compare the efficacy of vedolizumab IV and placebo in terms of the percentage of subjects with chronic or recurrent pouchitis achieving clinically relevant remission.Secondary Objectives:To assess the efficacy of vedolizumab IV…
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: 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…
The sponsor is developing a compound (PB016) similar to Entyvio® (vedolizumab, hereafter referred to as Entyvio). As part of medical-scientific studies to confirm the similarity of the biological products, the sponsor wants to compare PB016 with EU-…
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…
The primary objective of this prospective placebo-controlled study is to assess the ability of vedolizumab to prevent postoperative endoscopic recurrence of Crohn*s disease in the neoterminal ileum.
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…