5 results
FT218 is a new formulation (composition) of the registered drug sodium oxybate. Sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid [GHB]) is registered under the name Xyrem® for the treatment of narcolepsy. The purpose of…
The primary objective is to determine the effect on progression-free survival (PFS) of adding MORAb-009 to the combination of pemetrexed and cisplatin in the treatment of subjects with unresectable malignant pleural mesothelioma (MPM). (Protocol ch…
Our objective is to map the pharmacokinetic / pharmacodynamic interaction between dexmedetomidine and remifentanil by observing changes in anesthetic depth, measured by hypnotic and analgesic endpoints such as modified observer*s assessment of…
The purpose of the study is to investigate how quickly and to what extent JZP-507 is absorbed and eliminated from the body (this is called pharmacokinetics). This will be compared to the pharmacokinetics of Xyrem®. If the results show that the…
Primary objectives:Cohorts 1 and 2Maintenance Arm(s) Combinations:-To assess efficacy of combination therapy with ONC201 and novel agent in participants with DMG based on median progression-free survival at 6 months (PFS6) Cohort 3-To assess…