drugset / Trial / NCT05161195

Roll-over Study to Allow Continued Access to Ribociclib

NCT05161195

Phase 4 Active not recruiting 134 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).

Timeline

Start
2022-07-07
Primary completion
2030-06-28
Completion
2030-08-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Ribociclib Small molecule
Background Anastrozole Other / unclassified
Background Fulvestrant Small molecule
Background Goserelin Other / unclassified
Background Letrozole Other / unclassified
Background Tamoxifen Small molecule