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Managed Access Program (MAP) Cohort Treatment Plan CLEE011A2408 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)

Trial Profile

Managed Access Program (MAP) Cohort Treatment Plan CLEE011A2408 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)

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 12 Dec 2024

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At a glance

  • Drugs Ribociclib (Primary)
  • Indications Cancer; HER2 negative breast cancer
  • Focus Expanded access; Therapeutic Use
  • Sponsors Novartis Pharmaceuticals

Most Recent Events

  • 03 Nov 2023 CLEE011A2006M is added for providing expanded access of ribociclib as adjuvant therapy for early-stage HR+HER2 breast cancer.
  • 03 Nov 2023 Status changed from completed to recruiting.
  • 15 Feb 2022 Status changed from recruiting to completed.

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