3 results
Primary:To assess the safety and tolerability of Firdapse after single and multiple doses Secondary:Part 1 only: To determine the dose-related PK profile of single, escalating doses of Firdapse;Part 2 only: To assess the steady-state plasma PK and…
The purpose of this study is to investigate how quickly and to what extent derazantinib is absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body. The pharmacokinetics of derazantinib when it is administered…
The primary objective is to compare the objective response rate (ORR) per Response Assessment in Neuro Oncology (RANO) criteria assessed by independent review committee (IRC) of DAY101 monotherapy versus standard of care (SoC) chemotherapy in…