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Clinical trial

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)

NCT04589650 is registered in ClinicalTrials.gov with Novartis Pharmaceuticals as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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)
Lead sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Overall status
Active, not recruiting
Start date
April 19, 2021
Completion date
January 9, 2031
Enrollment
236 (actual)
Sites
36

Conditions

As the registry lists them; a condition with its own page is linked.

pik3ca-related overgrowth spectrum (pros)