5 results
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:…
The primary objective is to assess the usability and feasibility of the VITAAAL intervention as blended-care intervention. Secondary/exploratory objectives are to evaluate clinical outcomes (e.g. Time in Range, estimated HbA1c, body weight, and…
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…
Phase 1. The primary objective is to asses the usability of the Diameter in secondary care to solve main user problems before the start of the second phase. Phase 2. The primary objective is to assess intervention usage and acceptability of the…