12 results
Step 1 Primary objective: To describe the population pharmacokinetics of flucloxacillin for non-critically ill patients and determine the influence of covariates (demographics and renal function) on the kinetics of flucloxacillin. Step 2Primary…
To demonstrate that crizotinib (Arm A) is superior to first-line chemotherapy, pemetrexed/cisplatin or pemetrexed/carboplatin (Arm B), in prolonging PFS in patients with advanced non-squamous NSCLC whose tumors harbor a translocation or inversion…
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…
To determine whether 4 weeks of total antibiotic treatment duration is non-inferior to 6 weeks in patients with complicated SAB who have responded well to the initial treatment.
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.
The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…
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 purpose of this study is to investigate how quickly and to what extent GS-4224 is absorbed and eliminated from the body. We study this when the study compound is administered alone and together with compounds that influence the activity of a…
The primary objective is to determine the absorption of orally administered antibiotics in patients with SBS, to guide in clinical decision making when faced with catheter related infections.
Primary objective* To study the antitumor activity and safety of crizotinib across predefined tumor types in patients whose tumors are harboring specific alterations in ALK and/or METSecondary objectives* To study the specificity of the kinase…
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…
: Our aim is to evaluate whether the current flucloxacillin absorption test is able to adequately predict the absorption of flucloxacillin compared to an absorption test after switch to oral therapy, and identify co-variants in order to improve the…