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Available NCT05038631

Managed Access Programs for LEE011, Ribociclib

Conditions: Breast Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Sponsor: Novartis Pharmaceuticals

Summary

The purpose of this registration is to list Managed Access Programs (MAPs) related to LEE011, Ribociclib

Eligibility Criteria

Inclusion Criteria: 1. An independent request was received from a licensed physician. 2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment. 3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial. 4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. 5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable). 6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program. 7. Managed Access provision is allowed per local laws/regulations.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05038631). StuddyBuddy aggregates publicly available trial information.