Managed Access Programs for BYL719, Alpelisib

April 9, 2026 updated by: Novartis Pharmaceuticals
The purpose of this registration is to list Managed Access Programs (MAPs) related to BYL719, Alpelisib

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 11, 2019

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBYL719F12001M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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