Managed Access Program (MAP) to Provide Access to Alpelisib (BYL719) for Patients With PIK3CA-Related Overgrowth Spectrum (PROS)

PIK3CA-Related Overgrowth Spectrum (PROS) Clinical Trial

Official title:
Managed Access Program (MAP) Cohort Treatment Plan CBYL719F12001M to Provide Access to Alpelisib (BYL719) for Patients With PIK3CA-Related Overgrowth Spectrum (PROS)

Status Available

Clinical Trial Summary

The purpose of this Cohort Treatment Plan is to allow access to alpelisib for patients diagnosed with PIK3CA-Related Overgrowth Spectrum (PROS) who fulfill certain eligibility criteria as specified in this document. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

PIK3CA-Related Overgrowth Spectrum (PROS)

Clinical Trial Details

NCT number	NCT04085653
Study type	Expanded Access
Source	Novartis
Contact	MAP requests are initiated by a licensed physician.https:// www.
Phone	1-888-669-6682
Email	novartis.email@novartis.com
Status	Available
Phase

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04285723` - Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib
Active, not recruiting	`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)	Phase 2
Completed	`NCT02428296` - Study of Sirolimus Therapy for Segmental Overgrowth Caused by Somatic PI3K Activation	Phase 2
Recruiting	`NCT04589650` - Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum	Phase 2
No longer available	`NCT03317366` - Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies