Managed Access Program (MAP) to Provide Alpelisib (BYL719) for Patients With PIK3CA-Related Overgrowth Spectrum (PROS)
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|ClinicalTrials.gov Identifier: NCT04085653|
Expanded Access Status : Available
First Posted : September 11, 2019
Last Update Posted : February 17, 2020
|First Submitted Date||September 5, 2019|
|First Posted Date||September 11, 2019|
|Last Update Posted Date||February 17, 2020|
|Brief Title||Managed Access Program (MAP) to Provide Alpelisib (BYL719) for Patients With PIK3CA-Related Overgrowth Spectrum (PROS)|
|Brief 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|
|Detailed Description||Not Provided|
|Study Type||Expanded Access|
|Expanded Access Type||Treatment IND/Protocol|
Alpelisib will be provided as 50 mg and 200 mg film coated tablets as individual patient supply and will be dosed on a flat scale of mg/day.
In Adult patients, alpelisib will be administered at a starting dose of 250 mg orally once daily on a continuous dosing schedule and can be adjusted for toxicity per the recommendations in this treatment plan.
In Pediatric patients, alpelisib will be administered at a starting dose of 50 mg orally once daily on a continuous dosing schedule and can be interrupted for toxicity per the recommendations in this treatment plan; no dose reductions are allowed.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Available|
|Listed Location Countries||Canada|
|Removed Location Countries|
|Responsible Party||Novartis ( Novartis Pharmaceuticals )|
|Study Sponsor||Novartis Pharmaceuticals|
|Verification Date||February 2020|