Managed Access Program (MAP) to Provide Access to Alpelisib (BYL719) for Patients With PIK3CA-Related Overgrowth Spectrum (PROS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04085653 |
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Expanded Access Status :
Available
First Posted : September 11, 2019
Last Update Posted : September 14, 2022
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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| Tracking Information | |||||||||
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| First Submitted Date | September 5, 2019 | ||||||||
| First Posted Date | September 11, 2019 | ||||||||
| Last Update Posted Date | September 14, 2022 | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Managed Access Program (MAP) to Provide Access to 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 | ||||||||
| Intervention | Drug: alpelisib
Alpelisib will be provided as 50 mg, 125mg and 200 mg film coated tablets as individual patient supply, and will be dosed on a flat scale of mg/day not to be adjusted to body weight or surface area. 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 maximum 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. Other Name: BYL719
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Expanded Access Status | Available | ||||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||||
| Removed Location Countries | Argentina, Australia, Belgium, Canada, Croatia, Denmark, Finland, Germany, Greece, India, Ireland, Israel, Korea, Republic of, Malaysia, Mexico, Netherlands, Poland, Russian Federation, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United States | ||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04085653 | ||||||||
| Current Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Novartis Pharmaceuticals | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Novartis | ||||||||
| Verification Date | September 2022 | ||||||||