Managed Access Programs for BYL719, Alpelisib
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT04085653
The Managed Access Programs provide alpelisib to patients with PIK3CA-Related Overgrowth Spectrum or HR-positive, HER2-negative advanced breast cancer with PIK3CA mutation. Eligibility requires a serious condition with no alternative therapy, inability to join clinical trials, and potential benefit outweighing risks. Local laws must permit access.
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Program Overview
The purpose of this registration is to list Managed Access Programs (MAPs) related to BYL719, Alpelisib
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
Eligibility Criteria
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.
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