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

ClinicalTrials.gov Identifier: NCT02934568

Novartis Reference Number: CLEE011X2X01B

Last Update: Sep 13, 2022

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.

Condition

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

Phase

Phase 2

Overall status

Recruiting

Start date

Dec 15, 2016

Completion date

Sep 03, 2024

Gender

All

Age(s)

80 Years and older (Child, Adult, Older Adult)

Interventions

Drug

LEE011

Single agent LEE011 or in combination with other treatments

Eligibility Criteria

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.