21 results
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…
The purpose of the study is to investigate to what extent FE 201836 is tolerated. It will also be investigated how quickly and to what extent FE 201836 is absorbed and eliminated from the body (this is called pharmacokinetics). Also the effect on…
The purpose of the study is to investigate to what extent FE 202217 is tolerated. It will also be investigated how quickly and to what extent FE 202217 is absorbed and eliminated from the body (this is called pharmacokinetics). Also the effect on…
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 objectives:1) Describe the PD effects on plasma ACTH and serum cortisol upon 100 µg hCRH injection with or without a preceding injection of 10 µg dDAVP 2 hours earlier and study the PK-PD relationship (*Block B*). In particular, the outcome…
The aim of this study is to investigate the influence of statin therapy on DDAVP mediated release of VWF and F VIII. We aim to investigate this by measuring F VIII and VWF levels by means of a prolonged DDAVP test prior and after 6 weeks of statin…
This proposal centers on hormone-behavior dynamics in paternal caregiving, with the goal of gaining a better understanding of the development of human paternal caregiving. There is limited information on the hormonal basis of caregiving patterns in…
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…
This study aims to collect biochemical evidence for the pro-hemostatic capacity of DDAVP in patients with cirrhosis, in order to proceed towards a more rational clinical use of this drug.
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 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: 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: 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…
To show a reduction in FVIII-concentrate consumption with perioperative desmopressin and FVIII concentrate combination treatment compared to FVIII concentrate monotherapy, without decreasing the effectivity of treatment.
1) To evaluate the safety and tolerability of MLT*s npMNAs2) To evaluate the pharmacokinetics of intradermal desmopressin administration via MLT*s npMNAs
The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) compared to other chemotherapy drugs of physician*s choice (which includes Capecitabine, Eribulin, Gemcitabine…
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.
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: 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 evaluate the effectiveness of the GerOnTe, ICT-based, integrated care pathway to improve patient 6-month quality of life, in Belgium and the Netherlands.SECONDARY OBJECTIVES• Evaluate the effectiveness of the GerOnTe patient-…