Managed Access Programs for BYL719, Alpelisib

NCT04085653 | Unknown

• 1 other identifier: CBYL719F12001M
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this registration is to list Managed Access Programs (MAPs) related to BYL719, Alpelisib

Conditions

PIK3CA-Related Overgrowth Spectrum (PROS); Breast Cancer

Keywords

BYL719; alpelisib; MAP

Interventions

alpelisib DRUG

Patients receive alpelisib

Also known as: BYL719

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
• The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
• There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
• The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
• Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
• Managed Access provision is allowed per local laws/regulations.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Alpelisib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

MAP requests are initiated by a licensed physician. https// www.novart is.com/healthcare-professionals/managed-access-programs

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 11, 2019
• Last Updated: April 14, 2026

Record last verified: 2026-04