Roll-over Study to Allow Continued Access to Ribociclib

Description

This is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.

Conditions

Metastatic Breast Cancer

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Study Overview

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Study Details

Study overview

This is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.

A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study

Roll-over Study to Allow Continued Access to Ribociclib

Condition
Metastatic Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Chandler

Ironwood Cancer and Research Centers, Chandler, Arizona, United States, 85224

Fayetteville

Highlands Oncology Group, Fayetteville, Arkansas, United States, 72703

Beverly Hills

Beverly Hills Cancer Center, Beverly Hills, California, United States, 90211

Fort Collins

Poudre Valley Hospital, Fort Collins, Colorado, United States, 80528

Orange

Mid Florida Hematology And Onc Ctr, Orange, Florida, United States, 32763

Savannah

Summit Cancer Care, Savannah, Georgia, United States, 31405

Thomasville

John D Archbold Memorial Hospital, Thomasville, Georgia, United States, 31792

Plainfield

Duly Health and Care, Plainfield, Illinois, United States, 60585

Goshen

Indian Univ Health Goshen Center forCancer, Goshen, Indiana, United States, 46526

Portland

Northern Light Mercy Hospital, Portland, Maine, United States, 04102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs, and the parent study has fulfilled its primary objective(s)
  • 2. Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study
  • 3. Currently has evidence of clinical benefit as determined by the Investigator
  • 1. Permanent discontinuation of ribociclib in the parent study
  • 2. Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study 3. Local access to commercially available ribociclib and reimbursed

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2028-02-16