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Managed Access Programs for BYL719, Alpelisib | Clinical Trials | Clareo Health

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AVAILABLENCT04085653

Managed Access Programs for BYL719, Alpelisib

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

Lead sponsor: Novartis Pharmaceuticals•View source on ClinicalTrials.gov

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Contacts

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

CONTACT

1-888-669-6682 [email protected]

Novartis Pharmaceuticals

CONTACT

Sponsors

Lead Sponsor

Novartis Pharmaceuticals

CBYL719F12001M - Available - Managed Access Program (MAP) Cohort to provide access to Alpelisib (BYL719) for patients with PIK3CA-Related Overgrowth Spectrum (PROS) CBYL719C2001M - Available - Managed Access Program (MAP) Cohort to provide access to alpelisib (BYL719) for patients with HR-positive, HER2-negative advanced breast cancer with mutated phosphoinositide 3-kinase who progressed on or after AI treatment

Age

All ages

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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.

Exclusion Criteria

•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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 14, 2026Terms

Trial snapshot

StatusAVAILABLE

Phase—

Enrollment—

Start date—

Last updatedApr 14, 2026

Condition

PIK3CA-Related Overgrowth Spectrum (PROS)Breast Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2026Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions