Overseen ByNader Sanai, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Waitlist Available
Sponsor: Nader Sanai
No Placebo Group
Breakthrough Therapy
Approved in 5 jurisdictions
Trial Summary
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.
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.Participant Groups
The trial tests Ribociclib given orally in 5 doses before tumor removal surgery. Patients are enrolled sequentially based on time intervals rather than randomized. The last dose is timed at one of three set periods before the operation.
1Treatment groups
Experimental Treatment
Group I: Administration of ribociclibExperimental Treatment1 Intervention
Subjects will be administered ribociclib prior to surgical resection of their tumor. All patients will be orally-administered 5 doses of LEE011 (900 mg/d) with the final dose occurring at one of 3 following intervals before brain tumor resection:
Cohort 1: last ribociclib dose 2-4 hours prior to craniotomy for tumor resection
Cohort 2: last ribociclib dose 6-8 hours prior to craniotomy for tumor resection
Cohort 3: last ribociclib dose 23-25 hours prior to craniotomy for tumor resection
Ribociclib is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:
🇪🇺 Approved in European Union as Kisqali for:
- Breast cancer
🇺🇸 Approved in United States as Kisqali for:
- Hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer
🇨🇦 Approved in Canada as Kisqali for:
- Hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer
🇯🇵 Approved in Japan as Kisqali for:
- Hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer
🇨🇭 Approved in Switzerland as Kisqali for:
- Hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Barrow Brain and SpinePhoenix, AZ
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Who is running the clinical trial?
Nader SanaiLead Sponsor
NovartisIndustry Sponsor
Ivy Brain Tumor CenterCollaborator
Barrow Neurological InstituteCollaborator