drugset / Trial / NCT07679269

Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.

NCT07679269

Phase 2 Not yet recruiting 51 enrolled Novartis Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
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