Ribociclib (LEE011) Rollover Study for Continued Access

• Status: Recruiting
• Trial end date: 2024-09-03
• Target enrollment: 0
• Participant gender: All

Summary

This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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.