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NCT05038631 Clinical Trial

Managed Access Programs for LEE011, Ribociclib

Breast Cancer Clinical Trial

Official title:
Managed Access Programs for LEE011, Ribociclib

Clinical Trial Details — Status: Temporarily not available

Administrative data
NCT number NCT05038631
Other study ID # CLEE011A2408
Secondary ID
Status Temporarily not available
Phase
First received
Last updated

Study information
Verified date April 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

Description:

CLEE011A2408 - No longer available - Managed Access Program (MAP) Cohort to provide access to ribociclib (LEE011, Kisqali®), for locally advanced or metastatic cancer resistant or refractory to available treatment options and candidate for therapy with a CDK inhibitor (including tumors with D-cyclin-CDK4/6-INK4a-Rb pathway abnormalities) CLEE011A2006M - Temporarily not available - Managed Access Program (MAP) Cohort to provide access to Ribociclib for patients diagnosed with early-stage HR+HER2 (stages II and III) - breast cancer requiring adjuvant treatment with an ET based regimen

Recruitment information / eligibility
Status Temporarily not available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ribociclib
Patients receive ribociclib

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals
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