5 results
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 purpose of this study is to evaluate the safety of darbepoetin alfa, inclusive of the effects on survival and cancer progression, and the necessity of blood transfusions.
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…
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…
Co-primary (tested in parallel for non-inferiority):- To compare daprodustat to rhEPO for CV safety (non-inferiority)- To compare daprodustat to rhEPO for Hgb efficacy(non-inferiority)