Ribociclib (LEE011) Rollover Study for Continued Access

Launched by NOVARTIS PHARMACEUTICALS · Oct 13, 2016

Keywords

ClinConnect Summary

This clinical trial is called the Ribociclib Rollover Study, and it aims to give patients continued access to a treatment called ribociclib (LEE011). This study is for people who are already participating in another study where they have been receiving ribociclib and are seeing positive results. The goal is to allow these patients to keep using ribociclib, either on its own or with other new treatments, even after the original study has finished or been stopped.

To be eligible for this trial, patients must currently be enrolled in a Novartis-sponsored study and be benefiting from ribociclib treatment as determined by their doctor. However, those who have been permanently taken off ribociclib in the original study cannot participate. The trial is open to all ages and genders, and it is currently recruiting new participants. By joining this study, patients can continue receiving a treatment that has been helping them manage their advanced cancer or bulky tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment.
• • 2. Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.
• Exclusion Criteria:
• • 1. Patient has been permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason.
• • 2. Patients who do not meet parent protocol criteria to continue study treatment.