5 results
To assess the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified, stenotic, de novo coronary lesions prior to stenting.
Part 1In Part 1 of the study, no study compound will be administered, but a bone marrow aspiration and a blood sample will be taken to evaluate an assay that will be used for Part 2 and Part 3 of the study. Because no nirogacestat is given, we can…
DOSE EXPLORATION:Primary:To determine the safety and tolerability of GSK2857916 in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each sub-study combination treatment.Secondary:…
To compare ACM at Day 42 following treatment with olorofim versus treatment with AmBisome® followed by SOC in the intent-to-treat (ITT) population of patients with IFD caused by proven IA at any site or probable lower respiratory tract disease (LRTD…
Primary:To determine the efficacy (as defined by progression-free survival [PFS]) of nirogacestat in adult participants with progressing DT/AF.Secondary:To evaluate the safety and tolerability of nirogacestat in adult participants with progressing…