Last Update: Apr 26, 2024
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
ClinicalTrials.gov Identifier:
NCT02934568
Novartis Reference Number:CLEE011X2X01B
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies
Phase2
Recruiting
50
Dec 15, 2016
Sep 01, 2026
All
- 80 Years (Child, Adult, Older Adult)

Interventions

Drug

LEE011

Single agent LEE011 or in combination with other treatments

Eligibility Criteria

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.

Worldwide Contacts

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Novartis Pharmaceuticals

+41613241111

Novartis Pharmaceuticals

1-888-669-6682