Ribociclib for Brain Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires that certain medications be stopped before starting the study drug. If you are taking tamoxifen or toremifene, a washout period (time without taking the medication) of 5 half-lives is needed. Additionally, medications that strongly affect liver enzymes (CYP3A4/5) or those with a risk of heart rhythm issues must be stopped 7 days before starting the study drug.
What data supports the effectiveness of the drug Ribociclib for brain cancer?
Is ribociclib safe for use in humans?
Ribociclib, also known as Kisqali, has been studied for safety in patients with advanced breast cancer. Common side effects include low white blood cell counts, nausea, tiredness, diarrhea, hair loss, vomiting, constipation, headache, and back pain. These side effects are generally manageable with careful monitoring and dose adjustments.12678
What makes the drug Ribociclib unique for treating brain cancer?
What is the purpose of this trial?
In the proposed trial, patients will be administered ribociclib prior to surgical resection of their tumor. Patients will be enrolled in time-intervals sequentially (non-randomized). All patients will be orally-administered 5 doses of LEE011 (900 mg/d) with the final dose occurring at one of 3 intervals before brain tumor resection.
Research Team
Nader Sanai, MD
Principal Investigator
Deputy Director of the Ivy Brain Tumor Center
Eligibility Criteria
Adults with recurrent glioma or meningioma who've had one prior surgery, can sign consent, and meet specific lab criteria. They must not have used ribociclib before, have other recent cancers (except certain skin/cervical cancers), significant heart issues, uncontrolled medical conditions, known hypersensitivity to ribociclib's components or be pregnant/nursing.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgical Treatment
Participants receive 5 doses of ribociclib (900 mg/d) prior to surgical resection of their tumor
Surgical Resection
Surgical resection of the brain tumor is performed after the final dose of ribociclib
Post-surgical Treatment
Patients with positive PK and PD effects continue treatment with ribociclib (21 days on, 7 days off) until unacceptable toxicity or disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment using radiographic and clinical response metrics
Treatment Details
Interventions
- Ribociclib
Ribociclib is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:
- Breast cancer
- Hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer
- Hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer
- Hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer
- Hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nader Sanai
Lead Sponsor
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania
Ivy Brain Tumor Center
Collaborator
Barrow Neurological Institute
Collaborator