6 results
To evaluate the long-term safety, tolerability and efficacy of ArikaceTM 590 mg for a maximum 12 cycles administered once daily, where each cycle consists of 28 days on treatment followed by 28 days off treatment.
To assess piperacillin concentrations during continuous dosing of P/T in critically ill patients; to determine PK variables, e.g. creatinine clearance, leading to a predictive mathematical model enabling TDM and ideally establishing better a priori…
Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…
The present study is aimed at identifying the specific routes of PM01183 excretion and elimination following its administration to patients with advanced tumors. Also, the study design may allow the identification and quantification, if possible, of…
Primary objective:To determine whether there is a difference in overall survival (OS) between lurbinectedin (PM01183)/doxorubicin (DOX) and a control armconsisting of best Investigator's choice between cyclophosphamide (CTX), doxorubicin (DOX)…
The objective of this study is to confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangiopancreatography (ERCP) or other duodenoscope-based procedures.