Access Programs for Alpelisib (BYL719)
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT04085653
This program provides access to the medication Alpelisib (BYL719) for patients with specific conditions who cannot participate in clinical trials.
Patient Parameters
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Program Overview
The Managed Access Programs (MAPs) are designed to provide the medication Alpelisib (BYL719) to patients with certain medical conditions who do not have other treatment options available. This includes patients with PIK3CA-Related Overgrowth Spectrum (PROS) and those with HR-positive, HER2-negative advanced breast cancer that has a specific genetic mutation and has worsened after previous treatment.
Description
There are two main programs under this access initiative:
- For patients with PIK3CA-Related Overgrowth Spectrum (PROS), a condition involving abnormal growth due to a genetic mutation.
- For patients with HR-positive, HER2-negative advanced breast cancer that has a mutation in the phosphoinositide 3-kinase gene and has progressed after treatment with aromatase inhibitors (AI).
These programs aim to provide Alpelisib (BYL719) to patients who meet specific criteria and do not have other treatment options.
Eligibility Criteria
Inclusion Criteria
- A licensed doctor has requested access on behalf of the patient.
- The patient has a serious or life-threatening condition with no other satisfactory treatment options.
- The patient cannot join or continue in a clinical trial.
- The potential benefits of using the medication outweigh the risks, considering the patient's condition.
- The patient meets any additional medical criteria set by experts or health authorities.
- Providing the medication will not disrupt any ongoing or planned clinical trials by Novartis.
- The program complies with local laws and regulations.
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