EPIK-P2: A Phase II double-blind study with an upfront, 16-week randomized, placebo-controlled period, to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS).
What is the goal of the study?
This Clinical Trial shall investigate the safety, efficacy and/or related properties of one or more active ingredients (each a ?Study Drug?), alone or in comparison to a placebo and/or one or more other active ingredients (each a ?Comparator Drug?). It is understood that various formulations of the Study Drug and Comparator Drug may be used in the Clinical Trial and, except where the contrary is clear from the context, the terms ?Study Drug? and ?Comparator Drug? mean each formulation actually used in the Clinical Trial and each active ingredient thereof.
Who can participate in the study?
Please contact the study team listed below to learn more.