Roll-over Study to Allow Continued Access to Ribociclib

A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study

ClinicalTrials.gov Identifier: NCT05161195

Novartis Reference Number: CLEE011A2412B

Last Update: Nov 14, 2022

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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 is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.

Condition 
Metastatic Breast Cancer
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Jul 07, 2022
Completion date 
Feb 16, 2028
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Ribociclib
Participants continue ribociclib as was administered in their parent study
Drug
Letrozole
Participants continue ribociclib in combination with letrozole as was administered in their parent study
Drug
Anastrozole
Participants continue ribociclib in combination with anastrozole as was administered in their parent study
Drug
Goserelin
Participants continue ribociclib in combination with goserelin as was administered in their parent study
Drug
Tamoxifen
Participants continue ribociclib in combination with tamoxifen as was administered in their parent study
Drug
Fulvestrant
All participants continue ribociclib in combination with fulvestrant as was administered in their parent study

Eligibility Criteria

Key inclusion Criteria:

Currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs, and the parent study has fulfilled its primary objective(s)
Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study
Currently has evidence of clinical benefit as determined by the Investigator

Key exclusion Criteria:

Permanent discontinuation of ribociclib in the parent study
Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study 3. Local access to commercially available ribociclib and reimbursed

Other protocol-defined inclusion/exclusion criteria may apply at the end

Study Locations

United States
Ironwood Cancer and Research Centers
Recruiting
Chandler, 85224 - Arizona
Contact: Jessica Lopez (480-855-2225) - [email protected] - Mikhail I Shtivelband
United States
Highlands Oncology Group
Recruiting
Fayetteville, 72703 - Arkansas
Contact: Adam Torres (479-587-1700) - [email protected] - J. Thaddeus Beck
United States
Beverly Hills Cancer Center
Recruiting
Beverly Hills, 90211 - California
Contact: Diana Amaya (310-432-8900) - [email protected] - Linnea Chap
United States
Poudre Valley Hospital
Recruiting
Fort Collins, 80528 - Colorado
Contact: (970-297-6155) Diana Medgyesy
United States
Mid Florida Hematology and Oncology Center
Recruiting
Orange City, 32763 - Florida
Contact: David Edwards (386-774-1223) - [email protected] - Santosh Nair
United States
Summit Cancer Care
Recruiting
Savannah, 31405 - Georgia
Contact: Rita Wiggins (912-651-5771) - [email protected] - Alison Spellman
United States
John D Archbold Memorial Hospital
Recruiting
Thomasville, 31792 - Georgia
Contact: Kendall Fowler (229-228-2800) - [email protected] - Josh D. Simmons
United States
Joliet Oncology-Hematology Associates
Recruiting
Joliet, 60435 - Illinois
Contact: Tonya Finger (815-730-3098) - [email protected] - Nafisa Burhani
United States
Indiana University Health Goshen Center for Cancer
Recruiting
Goshen, 46526 - Indiana
Contact: Jillian Kimp (574-535-2888) - [email protected] - Ebenezer A Kio
United States
Northern Light Mercy Hospital
Recruiting
Portland, 04102 - Maine
Contact: (207-553-6868) Anna Niegowska
United States
Englewood Health
Recruiting
Englewood, 07631 - New Jersey
Contact: Audrey Ades (201-568-5250) - [email protected] - Jill Morrison
United States
The Valley Hospital / Luckow Pavillion
Recruiting
Paramus, 07652 - New Jersey
Contact: (201-634-5792) Eleonora Teplinsky
United States
Eastchester Center for Cancer Care
Recruiting
Bronx, 10469 - New York
Contact: Ida Rivera (718-732-4000) - [email protected] - Fabio Volterra
United States
University Hospitals of Cleveland Seidman Cancer Center
Recruiting
Cleveland, 44106 - Ohio
Contact: Crystal Moore - [email protected] - Cynthia Owusu
United States
Oklahoma Cancer Specialists and Research Institute
Recruiting
Tulsa, 74136 - Oklahoma
Contact: Andrea Niceley (918-292-8085) - [email protected] - Kevin Weibel
United States
Millennium Research Clin Develop
Recruiting
Houston, 77090 - Texas
Contact: (832-561-1840) Isaac Levy
United States
Brazil
Novartis Investigative Site
Recruiting
Ijuí, 98700-000
RS
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 01317 000
SP
Brazil
Novartis Investigative Site
Recruiting
São Paulo, 03102
SP
Brazil
Hong Kong
Novartis Investigative Site
Recruiting
Hong Kong,
-
Hong Kong
Novartis Investigative Site
Recruiting
Shatin, New Territories,
-
Hong Kong
Italy
Novartis Investigative Site
Recruiting
Meldola, 47014
FC
Italy
Japan
Novartis Investigative Site
Recruiting
Osaka-city, 540-0006
Osaka
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113-8431
Tokyo
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113-8677
Tokyo
Japan
Novartis Investigative Site
Recruiting
Koto ku, 135 8550
Tokyo
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03722
-
Korea, Republic of
Poland
Novartis Investigative Site
Recruiting
Gdansk, 80 952
-
Poland
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119228
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Sant Joan Despi, 08970
Barcelona
Spain
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10041
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei,
-
Taiwan
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35040
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]