25 results
Primary ObjectivesIn patients with primary hypercholesterolemia and high cardiovascular risk with LDL-C >=100 mg/dL (2.59 mmol/L) and <=160 mg/dL (4.14 mmol/L), to evaluate:1)at the end of Phase I, the additional LDL-C percentage…
The primary objective of this study is:* To evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of…
The primary objective of this study is:* To evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College 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…
The primary objective of this study is:* To evaluate the long-term safety and tolerability of filgotinib in subjects who have completed one of the parent studies of filgotinib in RA.The secondary objectives of this study are:* To evaluate the long-…
The overall objective of the study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of remission in subjects with moderately to severely active Ulcerative Colitis (UC). Subjects who are biologic-naïve and…
The purpose of this study is to see how filgotinib, the experimental drug, affects male sperm and to see if it is a safe and effective treatment for men with moderately to severely active inlammatory bowel disease.
We hypothesize that treatment of RA can be individualized by taking into account the presence of autoantibodies and quick response to glucocorticoids and JAK inhibitors. Therefore, the aims of this randomized controlled trial are: 1. To compare…
To assess uptake of 11C-osimertinib in tumor lesions of T790M double positive patients and T790M double negative patients, thereby evaluating specific and aspecific (off-target) 11C-osimertinib accumulation in tumor tissue.
Primary objectiveTo assess the efficacy of the combination of osimertinib and bevacizumab versus osimertinib alone in terms of progression-free survival (PFS) assessed by RECIST 1.1.Secondary Objectives:To compare short and long term clinical…
To investigate the effect of a CYP3A4 inhibitor (itraconazole) on the PK of AZD9291.
To assess the efficacy of AZD9291 compared to placebo as measured by disease free survival (DFS)Protocol v1.0, 4Jun2015, p30
To investigate the effect of a CYP3A4 inducer (rifampicin) on the PK of AZD9291.
The hypothesis is that the amivantamab and lazertinib combination (Arm A) will demonstrate superior PFS compared with single-agent osimertinib (Arm B).
The objective of this trial is to evaluate safety (in terms of grade >=2 pneumonitis, requiringmedical treatment) and efficacy (in terms of PFS) in patients with synchronous oligometastatic EGFR-mutant NSCLC treated with osimertinib and…
The main objective of this pilot study is to determine the intratumoral concentrations of osimertinib upon 1 week of treatment in peritoneal metastasis of patients who are candidate for CRS-HIPEC treatment (group 1) and in liver metastasis of…
The main objective of this study is to assess the efficacy of tepotinib combined with osimertinib inparticipants with advanced or metastatic EGFRm+ NSCLC and MET amplification, determined centrally by FISH.The secondary objectives are the following:…
The primary objective of this study is:* To evaluate the effect of filgotinib compared to placebo in active psoriatic arthritis (PsA) as assessed by the American College of Rheumatology 20% improvement (ACR20) response at Week 12Secondary objectives…
• to assess the efficacy of the sequential combination strategy of front-line afatinib-chemo, followed by a treatment with osimertinib-chemo in those patients that develop a T790M mutation as a mechanism of resistance.
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in
Subjects with Ulcerative Colitis
The primary objective of this study is:* To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-Sponsored filgotinib treatment study in UCThe…