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ACTIVE NOT RECRUITING
NCT05161195
PHASE4

Roll-over Study to Allow Continued Access to Ribociclib

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

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

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