5 results
MAIN OBJECTIVESDose escalation study:To establish the safe use of trastuzumab (Synthon BV, the Netherlands) in healthy volunteers at different dose levels up to 6 mg/kg.Bioequivalence study:Demonstrate bioequivalence between trastuzumab (Synthon BV…
See page 9Primary Objective:The primary objective of this study is to explore the relationship between MPH and academic activity and the mediating roles of ADHD behaviours, cognitive deficits and motivational deficits in this relationship. Therefore…
Pertuzumab is the investigational agent being studied for the treatment of HER2-positive gastric cancer. This study is to compare the overall survival (OS) in patients treated with pertuzumab in addition to trastuzumab (Herceptin®) plus cisplatin…
The primary objective of this study is to show equivalence of the total pathological complete response rate (tpCR) in patients treated withHD201 plus chemotherapy to that in patients treated with Herceptin® plus chemotherapy. tpCR will be assessed…
Primary ObjectivesSafety run-in Part 1:To confirm the recommended dose of alpelisib in combination with trastuzumab and pertuzumab for Part 2.Double-blind, randomized, placebo-controlled Part 2:To determine whether treatment with alpelisib in…