5 results
The aim is to assess the long-term safety of topical use of ZORBLISA in patients with Epidermolysis Bullosa (EB).
The primary objective is to compare the efficacy and safety of SD-101-6.0vs. SD- 101-0.0 (placebo) in patients with Simplex, RecessiveDystrophic, or Junctional non Herlitz Epidermolysis Bullosa.The primary endpoint is the complete closure of the…
Primary Objective:• To assess and compare efficacy of sacituzumab govitecan to TPC as measured by progression free survival (PFS) as determined by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1…
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…
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…