Ribociclib (LEE011) Rollover Study for Continued Access
Running, not enrolling · Phase 2
Conditions studied: Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies
In brief
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.
Key facts
- Study ID
- NCT02934568
- Run by
- Novartis Pharmaceuticals
- People needed
- 22
- Starts
- 2016-12-15
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-04-16
Who can join
Age: any, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment.
- Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.
You may not qualify if…
- Patient has been permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason.
- Patients who do not meet parent protocol criteria to continue study treatment.
Where it is running
- University Of Alabama At Birmingham — Birmingham, Alabama, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- The Regents of the Uni of Michigan — Ann Arbor, Michigan, United States
- Broome Oncology — Johnson City, New York, United States
- St Jude Childrens Research Hospital — Memphis, Tennessee, United States
- Novartis Investigative Site — Lyon, France
- Novartis Investigative Site — Villejuif, France
- Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
- Novartis Investigative Site — Singapore, Singapore
- Novartis Investigative Site — Madrid, Spain
- Novartis Investigative Site — Madrid, Spain
- Novartis Investigative Site — Tainan, Taiwan
- Novartis Investigative Site — Taipei, Taiwan
Full record on ClinicalTrials.gov
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