23 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…
Primary Objective- Compare the safety and efficacy of subcutaneous somavaratan and daily rhGH during 12 months of treatment.Secondary Objective-Evaluate and compare changes in pharmacodynamic responses (IGF-I, IGF binding protein-3 (IGFBP-3), growth…
The primary objective of this study is to assess the relation between the short term metabolic changes after start of rhGH therapy and the long term change in height SDS after one and two years of treatment. Secondly, we want to assess the effects…
To assess the impact of 7 daily subcutaneous gifts of GH on circulating Klotho levels in human sugjects with CKD stage III and healthy age-matched controls.
The primary objective of this study is to assess the effect of individualizing the growth hormone dose versus standard treatment with 1 mg/m2/day on adult height and the first and five year growth response. Secondly, we want to assess the long term…
to evaluate the effects of GH versus withdrawal of GH, after final height is reached, on weight, body composition, psychosocial functioning, carbohydrate metabolism, circulating lipids, and respiratory function during transition period until the age…
Primary objective: Assessment of the value of the short-term (2 weeks) response of IGF-I (peak IGF-I SDS) to GH in a dosage of 1.4 mg/m2/day (as part of a dose-escalation IGF-I generation test) in comparison to baseline IGF-I to predict the 1 year…
The primary objective of this study is to assess the effect of individualizing the growth hormone dose versus standard treatment with 1 mg/m2/day on adult height. Secondly, we want to assess the first and five year growth response, the long term…
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.
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…
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: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…
To evaluate whether GH substitution in patients with an isolated GHD after TBI could reverse the severity of symptoms which characterize GHD.
The aim of this study is to measure the results of refractive surgery with aspherical intra-ocular lenses quickly and reliably.
To investigate the effects of GH treatment on body composition, psychosocial development, psychomotor development, growth, glucose metabolism, serum lipids, cognition, behaviour, bone mineral density, quality of life and safety parameters in…
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…
To evaluate the effects of GH, after final height is reached, on weight, body composition, psychosocial functioning, carbohydrate metabolism and serum lipids. To find an optimal dose growth hormone for adults with PWS. We aimed to stabilize the body…
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…