4 results
For Part A: the purpose of this part is to investigate the effect of multiple oral doses of the new study drug on how quickly and to what extent glimepiride is absorbed and eliminated from the body (this is called pharmacokinetics), if glimepiride…
Part I (dose-escalation): to evaluate the safety of SYD985 and to determine the Maximum Tolerated Dose and Recommended Phase 2 DosePart II (expanded cohorts): to evaluate the Objective tumour Response Rate
PRIMARYTo demonstrate an effect of recAP on 28-day all-cause mortality.SECONDARY1. To investigate the effect of recAP on long-term Major Adverse Kidney Events (MAKE).2. To investigate the effect of recAP on use of organ support, i.e., mechanical…
The primary objective of this study is to demonstrate that SYD985 is superior to physician*s choice in prolonging progression-free survival (PFS) on the basis of the blinded independent central review of tumour assessment.The secondary objectives of…