Managed Access Programs for LEE011, Ribociclib

Sponsor: Novartis Pharmaceuticals

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05038631

Patient View

The Managed Access Programs for Ribociclib include CLEE011A2408, now closed, for advanced/metastatic cancer, and CLEE011A2006M, open for early-stage HR+HER2 breast cancer needing adjuvant ET. Eligibility requires a physician's request, no alternative therapy, and potential benefit-risk balance. Ribociclib is provided without affecting Novartis trials, adhering to local laws.

Patient Parameters

Program Overview

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 - 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

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.

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