5 results
- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 7 days per dosing cycle - Evaluate the pharmacokinetics of gemcitabine and 2',2'-difluorodeoxyuridine (dFdU, a gemcitabine-related metabolite) exposure in…
The objectives of this study are to:- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 21 days per dosing cycle.- Evaluate the pharmacokinetics of gemcitabine and 2', 2'-difluorodeoxyuridine (dFdU, a…
To investigate the safety and efficacy of quizartinib in children and adolescents with newly diagnosed FLT3-ITD positive AML with normal NPM1.
Primary Objectives:• Phase 1 Only: To determine the recommended Phase 2 dose(RP2D) of quizartinib, in combination with chemotherapy, forsubjects in the older (>=1 year old to <=21 years old) and younger(>=1 month old to <…
Primary ObjectiveThe primary objective of this study is to determine whether nSTRIDE APS is superior to HA in mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 pain score (change from baseline to 12 months post-…