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

2019-09-15 03:11:35 | BioPortfolio

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

Study Design

Conditions

PIK3CA-Related Overgrowth Spectrum (PROS)

Intervention

alpelisib

Status

Available

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-15T03:11:35-0400

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Medical and Biotech [MESH] Definitions

These disorders are related to both SCHIZOPHRENIA SPECTRUM AND RELATED DISORDERS and DEPRESSIVE DISORDERS in terms of symptomatology, family history, and genetics. (DSM-V) .

A malabsorption syndrome that is associated with a blind loop in the upper SMALL INTESTINE that is characterized by the lack of peristaltic movement, stasis of INTESTINAL CONTENTS, and the overgrowth of BACTERIA. Such bacterial overgrowth interferes with BILE SALTS action, FATTY ACIDS processing, MICROVILLI integrity, and the ABSORPTION of nutrients such as VITAMIN B12 and FOLIC ACID.

A complex of three different closely related aminoglycoside sulfates, Gentamicins C1, C2, and C1(subA), obtained from Micromonospora purpurea and related species. They are broad-spectrum antibiotics, but may cause ear and kidney damage. They act to inhibit protein synthesis (GENETIC TRANSLATION).

A broad-spectrum 6-fluoronaphthyridinone antibacterial agent (FLUOROQUINOLONES) structurally related to NALIDIXIC ACID.

A benzimidazole broad-spectrum anthelmintic structurally related to MEBENDAZOLE that is effective against many diseases. (From Martindale, The Extra Pharmacopoeia, 30th ed, p38)

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