6 results
Primary: To estimate the MTD or RDE and preferred dosing schedule of LJM716 when administered in combination with trastuzumab in patients with HER2 overexpressing metastatic breast cancer or gastric cancer.Secondary: Safety and tolerability, PK, PD…
Primary:*To identify the maximum tolerated dose (MTD) and to investigate the pharmacokinetics (PK) of a single dose of lanreotide PRF in subjects with acromegalySecondary:*To investigate the safety and tolerability of a single dose of lanreotide PRF…
The primary objective is to quantify the remimazolam exposure-response relationship with and without remifentanil in regard to various stages of MOAA/S for procedural and ICU sedation and general anaesthesiaSecondary objectives are:- Quantification…
Primary Objective* To describe the antitumour efficacy of LAN monotherapy plus BSC every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria,…
The objectives are:* to show non-inferiority of remimazolam compared with propofol in terms of successful maintenance of sedation defined as a Narcotrend index of 60 or less during at least 85% of the maintenance time without the use of rescue…
Primary ObjectiveThis is a confirmatory trial to establish non-inferior efficacy of remimazolam compared with propofol for induction and maintenance of GA for the purpose of elective surgery in patients classes III and IV based on the American…