5 results
Primary objective:•To establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with relapsed/refractory AML Secondary objectives:•To determine the safety and tolerability of this combination•To determine…
To evaluate the long-term safety and tolerability of TAK-861.
Primary:- To assess the effect of TAK-861 on EDS as measured by sleep latency from the MWT.Secondary:- To assess the effect of TAK-861 on EDS as measured by the Epworth Sleepiness Scale (ESS) total score. - To evaluate the safety and tolerability of…
Primary Objective:- Achieving an event-free survival, which is not inferior to the ML-DS 2006 trial (87±3%)Secondary Objective(s):- Reduction of toxicity: severe adverse events (CTCAE v4.0 grade III or higher)- Evaluation of response- Identification…
This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 as a single agent (Phase Ia) or in combination with a checkpoint inhibitor targeting the PD-L1/PD-1 axis (Phase Ib) in patients with locally advanced or…