Breast Cancer Clinical Trial
Roll-over Study to Allow Continued Access to Ribociclib
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.
Full 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
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
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There are 25 Locations for this study
Fayetteville Arkansas, 72703, United States More Info
Principal Investigator
Beverly Hills California, 90211, United States More Info
Principal Investigator
Fort Collins Colorado, 80528, United States More Info
Principal Investigator
Orange City Florida, 32763, United States More Info
Principal Investigator
Savannah Georgia, 31405, United States More Info
Principal Investigator
Thomasville Georgia, 31792, United States More Info
Principal Investigator
Joliet Illinois, 60435, United States More Info
Principal Investigator
Goshen Indiana, 46526, United States More Info
Principal Investigator
Portland Maine, 04102, United States More Info
Principal Investigator
Englewood New Jersey, 07631, United States More Info
Principal Investigator
Paramus New Jersey, 07652, United States More Info
Principal Investigator
Bronx New York, 10469, United States More Info
Principal Investigator
Cleveland Ohio, 44106, United States More Info
Principal Investigator
Tulsa Oklahoma, 74136, United States More Info
Principal Investigator
Houston Texas, 77090, United States More Info
Principal Investigator
Hong Kong , , Hong Kong
Meldola FC, 47014, Italy
Osaka-city Osaka, 540-0, Japan
Bunkyo ku Tokyo, 113-8, Japan
Bunkyo ku Tokyo, 113-8, Japan
Koto ku Tokyo, 135 8, Japan
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Gdansk , 80 95, Poland
Singapore , 11922, Singapore
Sant Joan Despi Barcelona, 08970, Spain
Izmir , 35040, Turkey
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