drugset / Trial / NCT07679269
Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2027-01-01
- Primary completion
- 2031-06-27
- Completion
- 2031-07-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpelisib | Small molecule | — | Oral |
| Background | Fulvestrant | Small molecule | — | Intramuscular |
| Background | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Background | Pertuzumab | Monoclonal antibody | — | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | — | Intravenous |