Trial intelligence / Profile preview

EPIK-P3: Long-term Safety and Efficacy of Alpelisib in PROS

NCT04980833Phase 2Active, not recruiting

Sponsor
Novartis
Start
Jan 2022
Primary completion
Jun 2027
Modality
Small Molecules
Countries
4
01

Overview

Phase 2, open-label, single-arm trial of alpelisib in PIK3CA-related overgrowth spectrum (PROS), sponsored by Novartis. Primary endpoint: Proportion of participants with new or worsening grade >=3 treatment emergent adverse events (AEs) at 5 years. Started Jan 2022; status: active, not recruiting.

02

Drugs

alpelisib
03

Conditions

PIK3CA-related overgrowth spectrum (PROS)

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