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

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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.

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
Enrollment count 
50 participants
Start date 
Dec 15, 2016
Completion date 
Sep 01, 2021
Gender 
All
Age(s)
(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.

Study Locations

United States
Novartis Investigative Site
Completed
Birmingham, 35294-3300
Alabama
United States
Novartis Investigative Site
Active, not recruiting
Boston, 02215
Massachusetts
United States
Novartis Investigative Site
Recruiting
Ann Arbor, 48109-5930
Michigan
United States
Novartis Investigative Site
Active, not recruiting
Johnson City, 13790
New York
United States
Novartis Investigative Site
Active, not recruiting
Memphis, 38105
Tennessee
United States
France
Novartis Investigative Site
Active, not recruiting
Villejuif Cedex, 94805
-
France
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119228
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Active, not recruiting
Madrid, 28041
-
Spain
Novartis Investigative Site
Completed
Madrid, 28050
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Tainan, 70403
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]