Managed Access Programs for LEE011, Ribociclib

Sponsor: Novartis Pharmaceuticals

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05038631

Provider View

This information is about special programs that allow patients to access the drug Ribociclib (also known as LEE011 or Kisqali®) when they have certain types of cancer and no other treatment options are available.

Patient Parameters

Program Overview

The purpose of these Managed Access Programs (MAPs) is to provide access to Ribociclib for patients with specific types of cancer who cannot be treated with standard therapies. These programs are designed for patients with advanced or metastatic cancer that is resistant to other treatments, as well as for those with early-stage hormone receptor-positive, HER2-negative breast cancer that requires additional treatment after surgery.

Description

There are two main programs for accessing Ribociclib:

  1. CLEE011A2408: This program is no longer available. It was designed to provide Ribociclib to patients with locally advanced or metastatic cancer that did not respond to other treatments and who were suitable for therapy with a CDK inhibitor. This includes cancers with specific genetic abnormalities.

  2. CLEE011A2006M: This program is currently available. It provides Ribociclib to patients with early-stage hormone receptor-positive, HER2-negative breast cancer (stages II and III) who need additional treatment after surgery, in combination with hormone therapy.

Eligibility Criteria

Inclusion Criteria

  • A licensed doctor must request the drug on behalf of the patient.
  • The patient has a serious or life-threatening condition with no other satisfactory treatment options.
  • The patient cannot join or continue in a clinical trial.
  • The potential benefits of using the drug outweigh the risks, considering the patient's condition.
  • The patient must meet any additional medical criteria set by experts or health authorities.
  • Providing the drug will not interfere with any ongoing or planned clinical trials by Novartis.
  • The program must comply with local laws and regulations.

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