Roll-over Study to Allow Continued Access to Ribociclib
- Conditions
- Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT05161195
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
The purpose of this study is to evaluate long-term safety and provide continued treatment to participants who are currently receiving ribociclib in combination with other drugs in a parent study, that has fulfilled requirements for its primary objective(s), and in the opinion of the Investigator, would benefit from continuing treatment at time of discontinuation from the parent study
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 137
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ribociclib Goserelin All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study. Ribociclib Ribociclib All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study. Ribociclib Fulvestrant All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study. Ribociclib Letrozole All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study. Ribociclib Anastrozole All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study. Ribociclib Tamoxifen All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study.
- Primary Outcome Measures
Name Time Method Percentage of participants with treatment-emergent adverse events (AES) From day of first dose of study medication to 30 days after last dose of study medication, up to 5 years The percentage of participants with treatment-emergent adverse events will be summarized, including significant adverse events leading to discontinuation, and adverse events leading to dose adjustment
- Secondary Outcome Measures
Name Time Method Clinical benefit rate Up to 5 years Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits
Trial Locations
- Locations (17)
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
🇻🇳Hanoi, Vietnam
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
🇺🇸Bronx, New York, United States