Clinical trial · Interventional
Ribociclib (LEE011) Rollover Study for Continued Access
An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LEE011 | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LEE011
- description
- All patients in all combinations with LEE011 will be entered in one arm.
- interventionNames
- Drug: LEE011
Primary outcomes (2)
- measure
- Number of Patients enrolled and received LEE011
- timeFrame
- up to 5 years (study duration)
- description
- Continued access to study treatment as a single agent or in combination with other investigational treatments until patients discontinue study
- measure
- Length of time receiving study treatment
- timeFrame
- up to 5 years (study duration)
- description
- Assessed by duration in days from start of study treatment until study treatment discontinuation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available