5 results
To assess whether in women with early PPROM tocolytics improve perinatal outcome.
Primary objective:To demonstrate that Eziclen, given on the day before colonoscopy has non-inferior efficacy to Klean-Prep on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight > 40 kg, scheduled to undergo a…
Primary Objective:Part 1:- To determine the MTD and recommended phase 2 dose (RP2D) of avapritinib.- To determine the safety and tolerability of avapritinib.Part 2:* To determine the overall response rate (ORR) by RECIST criteria at the MTD/RP2D of…
Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…
Primary:1. To characterize the safety and tolerability of multiple oral doses of K-196 alone and in combination with naproxen/omeprazole in healthy subjects.Secondary:1. To assess the effects of K-196 compared to placebo on the proportion of…