3 results
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
Primary ObjectivesTo assess the effects of pexidartinib on the PK parameters of single-dose midazolam and tolbutamide in patients.Secondary ObjectivesTo evaluate:- To determine the overall response rate (ORR) in patients with TGCT,kit-mutant…
Main objective: Proportion of subjects who remain treatment-free.Secondary objectives: - Change from Baseline in Patient Reported Outcomes (PROs) (PROMISPF, EQ-5D-5L)- Safety: Total number of subjects in the safety analysis set with any AEcollected…