6 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 increase the major pathological response rate (< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.
Primary Objectives:- To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in all randomized patients based on PFS (per RECIST 1.1 as assessed by BICR)- To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in…
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…
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…