Continued access to ribociclib for patients benefiting from prior treatment

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

This study lets patients who are doing well on ribociclib continue their treatment, either alone or with other new therapies, to help manage their advanced solid tumors.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: N/A to 80 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Locations: 13 sites (Birmingham, Alabama and 12 other locations)
• Trial ID: NCT02934568 on ClinicalTrials.gov

What this trial studies

This study allows patients who are currently benefiting from ribociclib (LEE011) in a Novartis-sponsored study to continue receiving the treatment, either as a single agent or in combination with other investigational therapies. It is designed for individuals whose previous studies have reached their primary objectives or have been halted for other reasons. The goal is to provide ongoing access to a potentially effective treatment for advanced solid tumors and malignancies.

Who should consider this trial

Good fit: Ideal candidates are patients currently enrolled in a Novartis-sponsored study who are receiving ribociclib and deriving clinical benefit from it.

Not a fit: Patients who have been permanently discontinued from ribociclib in the parent protocol or do not meet the criteria for continued treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide patients with continued access to a treatment that is currently benefiting them.

How similar studies have performed: Other studies involving ribociclib have shown promise, indicating that this approach may build on existing successful treatments.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

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.

Where this trial is running

Birmingham, Alabama and 12 other locations

• University Of Alabama At Birmingham — Birmingham, Alabama, United States (Completed)
• Dana Farber Cancer Institute Main Site — Boston, Massachusetts, United States (Completed)
• The Regents of the University of Michigan — Ann Arbor, Michigan, United States (Completed)
• Broome Oncology SC-2 — Johnson City, New York, United States (Completed)
• St Jude Childrens Research Hospital — Memphis, Tennessee, United States (Recruiting)
• Novartis Investigative Site — Lyon, France (Completed)
• Novartis Investigative Site — Villejuif, France (Completed)
• Novartis Investigative Site — Singapore, Singapore (Completed)
• Novartis Investigative Site — Barcelona, Catalunya, Spain (Withdrawn)
• Novartis Investigative Site — Madrid, Spain (Active_not_recruiting)
• Novartis Investigative Site — Madrid, Spain (Completed)
• Novartis Investigative Site — Tainan, Taiwan (Recruiting)
• Novartis Investigative Site — Taipei, Taiwan (Completed)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Continued Access to Study Treatment, Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies; Ribociclib; LEE011