RECRUITING

Ribociclib (LEE011) Rollover Study for Continued Access

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2016-12-15
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02934568

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.

Ages Eligible for Study:Not specified to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.
  1. 1. Patient has been permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason.
  2. 2. Patients who do not meet parent protocol criteria to continue study treatment.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
Novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Study Locations (Sites)

University Of Alabama At Birmingham
Birmingham, Alabama, 35294-3300
United States
Dana Farber Cancer Institute Main Site
Boston, Massachusetts, 02215
United States
The Regents of the University of Michigan
Ann Arbor, Michigan, 48109-5930
United States
Broome Oncology SC-2
Johnson City, New York, 13790
United States
St Jude Childrens Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-12-15
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2016-12-15
Study Completion Date2026-09-01

Terms related to this study

Keywords Provided by Researchers

  • Ribociclib
  • LEE011

Additional Relevant MeSH Terms

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