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Roll-over Study to Allow Continued Access to Ribociclib
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).
Official title: A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2022-07-07
Completion Date
2030-08-14
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Ribociclib
Participants continue ribociclib as was administered in their parent study
Letrozole
Participants continue ribociclib in combination with letrozole as was administered in their parent study
Anastrozole
Participants continue ribociclib in combination with anastrozole as was administered in their parent study
Goserelin
Participants continue ribociclib in combination with goserelin as was administered in their parent study
Tamoxifen
Participants continue ribociclib in combination with tamoxifen as was administered in their parent study
Fulvestrant
All participants continue ribociclib in combination with fulvestrant as was administered in their parent study
Locations (73)
Ironwood Cancer and Research Centers
Chandler, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Mid Florida Hematology And Onc Ctr
Orange, Florida, United States
Summit Cancer Care
Savannah, Georgia, United States
John D Archbold Memorial Hospital
Thomasville, Georgia, United States
Duly Health and Care
Plainfield, Illinois, United States
Indian Univ Health Goshen Center forCancer
Goshen, Indiana, United States
Northern Light Mercy Hospital
Portland, Maine, United States
Englewood Health
Englewood, New Jersey, United States
The Valley Hospital-Luckow Pavillion
Paramus, New Jersey, United States
Eastchester Center for Cancer Care
The Bronx, New York, United States
University Hospitals of Cleveland Seidman Cancer Center
Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States
Millennium Research Clin Develop
Houston, Texas, United States
Novartis Investigative Site
San Juan, Argentina
Novartis Investigative Site
Natal, Rio Grande do Norte, Brazil
Novartis Investigative Site
Ijuí, Rio Grande do Sul, Brazil
Novartis Investigative Site
Florianópolis, Santa Catarina, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Sao Jose Rio Preto, Brazil
Novartis Investigative Site
São Paulo, Brazil
Novartis Investigative Site
Chongqing, Chongqing Municipality, China
Novartis Investigative Site
Shijiazhuang, Hebei, China
Novartis Investigative Site
Harbin, Heilongjiang, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Suzhou, Jiangsu, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Kunming, Yunnan, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Qingdao, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
San José, Costa Rica
Novartis Investigative Site
Heraklion Crete., Greece
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Bhubaneswar, Odisha, India
Novartis Investigative Site
Delhi, India
Novartis Investigative Site
Meldola, FC, Italy
Novartis Investigative Site
Osaka, Osaka, Japan
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan
Novartis Investigative Site
Koto Ku, Tokyo, Japan
Novartis Investigative Site
El Chouf, LBN, Lebanon
Novartis Investigative Site
Beirut, Lebanon
Novartis Investigative Site
Beirut, Lebanon
Novartis Investigative Site
San Pedro G G, Mexico
Novartis Investigative Site
Trujillo, La Libertad, Peru
Novartis Investigative Site
San Borja, Lima region, Peru
Novartis Investigative Site
Gdansk, Poland
Novartis Investigative Site
Lisbon, Portugal
Novartis Investigative Site
Loures, Portugal
Novartis Investigative Site
Porto, Portugal
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Cape Town, South Africa
Novartis Investigative Site
Johannesburg, South Africa
Novartis Investigative Site
Pretoria, South Africa
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Sant Joan Despí, Barcelona, Spain
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Malatya, Battalgazi, Turkey (Türkiye)
Novartis Investigative Site
Diyarbakır, Sur, Turkey (Türkiye)
Novartis Investigative Site
Izmir, Turkey (Türkiye)
Novartis Investigative Site
Kecioren Ankara, Turkey (Türkiye)
Novartis Investigative Site
Hanoi, Vietnam