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).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05161195.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Active
Name Not Available
This is an open-label, multi-center, roll-over study to evaluate the long-term safety of
ribociclib in combination with other drugs in participants who are participating in a
Novartis sponsored global study, that has fulfilled requirements for its primary
objective(s), and who in the opinion of the Investigator, would benefit from continued
treatment.
This roll-over study will not include a screening phase, participants will directly
transfer at the completion of the parent study. Eligible participants will start
receiving ribociclib in combination with other drugs (as per parent protocol) only after
they have signed the Informed Consent and have met the selection criteria for this
roll-over study.
Participants should return to the study center for resupply of the study medication and
for safety and clinical benefit assessment, at a minimum, every 24 weeks, or more
frequently at any given time required as per local practice.
Lead OrganizationNovartis Pharmaceuticals Corporation