6 results
PRIMARY OBJECTIVEPart 1: Safety Run-in PhaseThe primary objective for Part 1 of this study is to determine the safety and tolerability of pertuzumab in combination with either topotecan or paclitaxel.Part 2The primary objective for Part 2 of this…
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…
Primary:To investigate the safety and tolerability of single oral administration of study medication in healthy postmenopausal females (Part I)To investigate the general safety and tolerability of the study medication in healthy postmenopausal…
Primary:To characterize the dose response of danirixin compared with placebo on the incidence and severity of respiratory symptoms in subjects with COPD and to compare the safety of danirixin with placebo.Secondary:To assess the annual rate of…
Primary:To assess the efficacy of treatment with IV danirixin twice daily given with oral oseltamivir compared to oral oseltamivir twice daily on time to clinical response (TTCR)Secondary:Time to respiratory response (TTRR), clinical measures of…
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…