Ribociclib (LEE011) Rollover Study for Continued Access

Status:	Active, not recruiting
Conditions:	Cancer, Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	8/30/2018
Start Date:	December 15, 2016
End Date:	January 21, 2019

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

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.

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.

We found this trial at

sites

Novartis Investigative Site

Villejuif Cedex, 94805

from

Villejuif Cedex,