Ribociclib (LEE011) Rollover Study for Continued Access

Description

This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.

Conditions

Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies

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Study Overview

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Study Details

Study overview

This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.

An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments

Ribociclib (LEE011) Rollover Study for Continued Access

Condition
Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies
Intervention / Treatment

-

Contacts and Locations

Birmingham

University Of Alabama At Birmingham, Birmingham, Alabama, United States, 35294-3300

Boston

Dana Farber Cancer Institute Main Site, Boston, Massachusetts, United States, 02215

Ann Arbor

The Regents of the University of Michigan, Ann Arbor, Michigan, United States, 48109-5930

Johnson City

Broome Oncology SC-2, Johnson City, New York, United States, 13790

Memphis

St Jude Childrens Research Hospital, Memphis, Tennessee, United States, 38105

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. Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment.
  • 2. Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.
  • 1. Patient has been permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason.
  • 2. Patients who do not meet parent protocol criteria to continue study treatment.

Ages Eligible for Study

to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Study Record Dates

2026-09-01