8 results
Primary Objectives:To assess the incidence and the time to confirmed IFI in subjects treated pre-emptively with micafungin versus placebo.
Primary Objectives 1. To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage and identify covariates…
The primary objective of this study is to evaluate the safety and tolerability of trastuzumab emtansine.
Primary objective:To determine the effect of obesity (BMI > 40kg/m2) on the pharmacokinetics of micafungin and develop a dosing regimen for obese patients. Secondary objective:* To describe the pharmacokinetics of the approved dose of 200mg…
A number of anti-HER2 therapies have proven efficacy, are approved and part of the Standard of Care for HER2-positive BC and GC. In contrary, there is currently no clinical data on the potential therapeutic effect of trastuzumab emtansine treatment…
-To dertermine the objective response rate (ORR) and disease control rate (DCR) (according to RECIST v1.1) after 3 months of treatment with T-DM1 and osimertinib in patients with EGFR mutation positive NSCLC and HER2 bypass track activation-To…
Primary objective:1. To evaluate IDFS with T-DXd treatment as compared to T-DM1Secundary objectives:1. To evaluate DFS with T-DXd treatment as compared to T-DM12. To evaluate OS with T-DXd treatment as compared to T-DM13. To evaluate DRFI with T-DXd…
To evaluate efficacy of image-guided de-escalating chemotherapy in the presence of dual HER2-blockade with Herceptin® and pertuzumab in HER2-positive breast cancer, as measured by three-year event-free survival.Secondary objectives• To evaluate 3-…