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alpelisib (BYL719)

DRUG3 trials

Sponsors

Novartis Pharmaceuticals, Centre Hospitalier Universitaire Dijon, Children's Hospital of Philadelphia

Conditions

Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)PI3K Pathway InhibitionPre-menopausal Breast CancerTIE2/PIK3CA Pathway Driven Vascular AnomaliesVascular AnomaliesVascular Anomaly

Phase 1

A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer
CompletedNCT02058381
Novartis PharmaceuticalsPI3K Pathway Inhibition, Pre-menopausal Breast Cancer
Start: 2014-05-06End: 2018-06-19Updated: 2020-03-09

Phase 2

Assessment of the Efficacy and Safety of Alpelisib (BYL719) in Pediatric and Adult Patients With Megalencephaly-CApillary Malformation Polymicrogyria Syndrome (MCAP)
RecruitingNCT05577754
Centre Hospitalier Universitaire DijonMegalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)
Start: 2022-11-28End: 2027-03-01Target: 20Updated: 2026-02-24
24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAs
Active, not recruitingNCT07543822
Children's Hospital of PhiladelphiaTIE2/PIK3CA Pathway Driven Vascular Anomalies, Vascular Anomalies, Vascular Anomaly
Start: 2025-08-27End: 2030-08-27Target: 61Updated: 2026-04-22

Related Papers

A phase II double-blind multicentre, placebo-controlled trial to assess the efficacy and safety of alpelisib (BYL719) in paediatric and adult patients with Megalencephaly-CApillary malformation Polymicrogyria syndrome (MCAP): the SESAM study protocol
BMJ Open2024-12-014 citations
Abstract P4-13-27: A phase Ib dose de-escalation study of combined tamoxifen and goserelin acetate with alpelisib (BYL719) or buparlisib (BKM120) in premenopausal patients with HR+/HER2– locally advanced or metastatic breast cancer
Cancer Research2016-02-154 citations