NCT04980833 - Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 27, 2022

Primary Completion Date

July 22, 2027

Study Completion Date

July 22, 2027

Conditions

PIK3CA-related Overgrowth Spectrum (PROS)

Interventions

DRUG

Alpelisib

Participant's treatment plan has been established by the treating physician, within the global compassionate use framework. Doses permitted are 50, 125, 200 and 250 mg.

Trial Locations (6)

12

Novartis Investigative Site, Dublin

21034

Novartis Investigative Site, Dijon

28046

Novartis Investigative Site, Madrid

34295

Novartis Investigative Site, Montpellier

75015

Novartis Investigative Site, Paris

02215

Boston Childrens Hospital, Boston