11 results
In this single centre pilot intervention study, we will investigate the effects of short-term administration of the angiotensin-receptor antagonist losartan on insulin sensitivity (assessed by using the homeostasis model assessment of insulin…
1. The effect of Losartan on the joint excursions and the Hardening of the skin in a patient with SSS.2. Gain insight in the pathogenesis of SSS3. Gain insight in the functional effect of Losartan in SSS.
Primary:• To evaluate the long-term safety and tolerability of seladelparSecondary:• To evaluate the long-term efficacy of seladelpar• To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)Exploratory• To evaluate the effect of…
Primary objectives• To identify the percentage of patients in which a drug resistant clone can be detected with ctDNA before the emergence of radiological progression.• To determine the success rate of crizotinib and osimertinib combination…
Primary: • To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placeboKey Secondary: • To evaluate the effect of seladelpar on…
The primary objective of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic NSCLC patients naive to ALK inhibitors, as evidenced by PFS.The secondary objectives of the study are:1. To…
This study will evaluate the efficacy and safety of entrectinib compared with crizotinib in patients who have NSCLC harboring ROS1 gene rearrangements with and without CNS metastases. Specific objectives and corresponding endpoints for the study are…
Primary Objective: • Efficacy: To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on alkalinephosphatase (ALP) and total bilirubin at 12 months of treatment compared to placebo• Safety:…
Primary• To determine the RP2D of crizotinib in combination with temsirolimus • To determine the safety and preliminary activity of single-agent crizotinib in ALK, MET or ROS1 positive tumors Secondary• To study the preliminary activity of…
To demonstrate that lorlatinib as a single agent (Arm A) is superior to crizotinib alone (Arm B) in prolonging Progression-Free Survival (PFS) in advanced ALK-positive NSCLC participants who are treatment naive.
Primary:To evaluate the efficacy and safety of Ensartinib vs. crizotinib in patients with ALK-positive NSCLC that have received up to 1 prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor (TKI).Secondary:To obtain additional…