Ribociclib (LEE011) Rollover Study for Continued Access

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies

Intervention / Treatment
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* Drug: LEE011


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEE011<br>All patients in all combinations with LEE011 will be entered in one arm. | Drug: LEE011<br>* Single agent LEE011 or in combination with other treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients enrolled and received LEE011 | Continued access to study treatment as a single agent or in combination with other investigational treatments until patients discontinue study | up to 5 years (study duration) | 
| Length of time receiving study treatment | Assessed by duration in days from start of study treatment until study treatment discontinuation | up to 5 years (study duration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and nature of adverse events (AEs), serious adverse events (SAEs), non-fatal SAEs and liver function assays. | The data include only AEs that started or worsened during the on-treatment-period, the treatment-emergent AEs. | up to 5 years (study duration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ribociclib, LEE011