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).
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. This roll-over study will not include a screening phase, participants will directly transfer at the completion of the parent study. Eligible participants will start receiving ribociclib in combination with other drugs (as per parent protocol) only after they have signed the Informed Consent and have met the selection criteria for this roll-over study. Participants should return to the study center for resupply of the study medication and for safety and clinical benefit assessment, at a minimum, every 24 weeks, or more frequently at any given time required as per local practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
134
Participants continue ribociclib as was administered in their parent study
Participants continue ribociclib in combination with letrozole as was administered in their parent study
Participants continue ribociclib in combination with anastrozole as was administered in their parent study
Percentage of participants with treatment-emergent adverse events (AES)
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
Time frame: From day of first dose of study medication to 30 days after last dose of study medication, up to 8 years
Clinical benefit rate
Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits
Time frame: Up to 8 years
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Participants continue ribociclib in combination with goserelin as was administered in their parent study
Participants continue ribociclib in combination with tamoxifen as was administered in their parent study
All participants continue ribociclib in combination with fulvestrant as was administered in their parent study
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
...and 63 more locations