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Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.
Official title: An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2026-12-15
Completion Date
2032-04-20
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
Alpelisib
Administered as oral tablets at dose levels as per the parent study, taken once daily.
Fulvestrant
Administered as an intramuscular injection at dose levels and dosing schedule as per standard of care, in accordance with the parent study.
Trastuzumab
Administered as an intravenous infusion of a reconstituted lyophilized powder at dose levels as per the parent study, given every 21 days.
Pertuzumab
Administered as an intravenous infusion of a solution concentrate at dose levels as per the parent study, given every 21 days.
Letrozole
Administered as oral tablets at a dose of 2.5 mg, taken once daily, as per the parent study.