Roll-over Study to Allow Continued Access to Ribociclib

Launched by NOVARTIS PHARMACEUTICALS · Dec 3, 2021

Keywords

ClinConnect Summary

This clinical trial is designed to study the long-term safety of a medication called ribociclib, which is used to treat metastatic breast cancer. In this study, patients who are already taking ribociclib as part of another research study can continue their treatment if their doctor believes it is still helping them. The trial will help researchers understand how safe ribociclib is when taken for a longer time, especially when combined with other medications.

To join this study, participants must currently be part of a Novartis-sponsored research study where they have been receiving ribociclib for at least six treatment cycles and are still benefiting from it. Unfortunately, those who have stopped taking ribociclib permanently or have unresolved side effects from the medication are not eligible. Participants can expect regular check-ups and monitoring to ensure the treatment continues to be safe and effective for them. This trial is open to all genders and is currently looking for participants aged between 65 and 74.

Gender

ALL

Eligibility criteria

• Key inclusion Criteria:
• • 1. Currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs, and the parent study has fulfilled its primary objective(s)
• • 2. Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study
• • 3. Currently has evidence of clinical benefit as determined by the Investigator
• Key exclusion Criteria:
• • 1. Permanent discontinuation of ribociclib in the parent study
• • 2. Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study 3. Local access to commercially available ribociclib and reimbursed
• • Other protocol-defined inclusion/exclusion criteria may apply at the end