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.
Interventions
Anastrozole
Fulvestrant
Goserelin
Letrozole
Ribociclib
Tamoxifen
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 Location
Novartis Investigative Site
Recruiting
Sao Paulo,SP,01317 000,Brazil
Novartis Investigative Site
Recruiting
São Paulo,SP,03102,Brazil
Novartis Investigative Site
Recruiting
Ijuí,RS,98700-000,Brazil
Novartis Investigative Site
Recruiting
Sao Paulo,01255-000,Brazil
Novartis Investigative Site
Recruiting
Heraklion Crete,711 10,Greece
Novartis Investigative Site
Recruiting
Shatin New Territories,Hong Kong
Novartis Investigative Site
Recruiting
Meldola,FC,47014,Italy
Novartis Investigative Site
Recruiting
Seoul,03080,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,03722,Korea, Republic of
Novartis Investigative Site
Recruiting
El Chouf,LBN,1503201002,Lebanon
Novartis Investigative Site
Recruiting
Ashrafieh,166830,Lebanon
Novartis Investigative Site
Recruiting
Beirut,1107 2020,Lebanon
Novartis Investigative Site
Recruiting
Gdansk,80 952,Poland
Novartis Investigative Site
Recruiting
Lisboa,1400-038,Portugal
Novartis Investigative Site
Recruiting
Pretoria,0002,South Africa
Novartis Investigative Site
Recruiting
Taipei,103616,Taiwan
Novartis Investigative Site
Recruiting
Taipei,10041,Taiwan
Novartis Investigative Site
Recruiting
Izmir,35040,Turkey
Novartis Investigative Site
Recruiting
Kecioren Ankara,06010,Turkey
Novartis Investigative Site
Recruiting
Malatya,44280,Turkey
Novartis Investigative Site
Recruiting
Diyarbakir,21000,Turkey
Eastchester Center for Cancer Care
Recruiting
Bronx,Sujey Diaz (718-732-4000) email: sudi[email protected] -- Fabio Volterra,10469 - New York,United States
Mid Florida Hematology and Onc Ctr
Recruiting
Orange,David Edwards (386-774-1223) email: de[email protected] -- Santosh Nair,32763 - Florida,United States
Englewood Health
Recruiting
Englewood,Audrey Ades (201-568-5250) email: [email protected] -- Jill Morrison,07631 - New Jersey,United States
Oklahoma Cancer Specialists and Research Institute
Recruiting
Tulsa,Andrea Niceley (918-292-8085) email: Andrea.[email protected] -- Kevin Weibel,74136 - Oklahoma,United States
Millennium Research Clin Develop
Recruiting
Houston,(832-561-1840) -- Isaac Levy,77090 - Texas,United States
Highlands Oncology Group
Recruiting
Fayetteville,Adam Torres (479-587-1700) email: ator[email protected] -- J Thaddeus Beck,72703 - Arkansas,United States
Poudre Valley Hospital
Recruiting
Fort Collins,Ashley Swim (+1 970 297 6155) email: [email protected] -- Chelsea Dianne Gawryletz,80528 - Colorado,United States
Northern Light Mercy Hospital
Recruiting
Portland,(207-553-6868) -- Anna Niegowska,04102 - Maine,United States
Summit Cancer Care
Recruiting
Savannah,Rita Wiggins (912-651-5771) email: [email protected] -- Alison Spellman,31405 - Georgia,United States
Indiana University Health Goshen Center for Cancer
Recruiting
Goshen,Jeremy Messick (574-535-2888) email: [email protected] -- Ebenezer A Kio,46526 - Indiana,United States
The Valley Hospital / Luckow Pavillion
Recruiting
Paramus,Sheena Patel (201-634-5792) email: [email protected] -- Eleonora Teplinsky,07652 - New Jersey,United States
Ironwood Cancer and Research Centers
Recruiting
Chandler,Priscilla Callendar (480-855-2225) email: [email protected] -- Mikhail I Shtivelband,85224 - Arizona,United States
University Hospitals of Cleveland Seidman Cancer Center
Recruiting
Cleveland,Crystal Moore email: Crystal.M[email protected] -- Cynthia Owusu,44106 - Ohio,United States
John D Archbold Memorial Hospital
Recruiting
Thomasville,Kendall Fowler (229-228-2800) email: kbfow[email protected] -- Josh D Simmons,31792 - Georgia,United States
Beverly Hills Cancer Center
Recruiting
Beverly Hills,Noel Vargas (310-432-8900) email: nvargas@mednet.ucla.edu -- Linnea Chap,90211 - California,United States
Joliet Oncology-Hematology Associates
Recruiting
Joliet,Tonya Finger (815-730-3098) email: [email protected] -- Nafisa Burhani,60435 - Illinois,United States
Novartis Investigative Site
Recruiting
Hanoi,100000,Vietnam
Worldwide Contacts
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