Continued Access to Ribociclib for Solid Cancers
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It seems focused on continuing ribociclib treatment for those already benefiting from it.
How does the drug ribociclib differ from other treatments for solid cancers?
Ribociclib is unique because it is a targeted therapy that works by inhibiting specific proteins (CDK4/6) involved in cell division, which can slow down or stop the growth of cancer cells. This mechanism is different from traditional chemotherapy, which generally targets all rapidly dividing cells.12345
Eligibility Criteria
This trial is for patients already participating in a Novartis-sponsored study using ribociclib (LEE011) alone or with other experimental treatments. They must be seeing positive results as judged by their doctor, and meet the original study's ongoing criteria.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Continued use of ribociclib (LEE011) as a single agent or in combination with other investigational treatments
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive ribociclib (LEE011) as long as they benefit from the treatment
Treatment Details
Interventions
- Ribociclib (LEE011)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD