Ribociclib for Brain Cancer

Overseen By Phase 0 Navigator

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.

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

You are 18 years old or older.

Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable)

Patient has voluntarily agreed to participate by giving written informed consent (personally or via legally-authorized representative(s), and assent if applicable)

Exclusion Criteria

You have a history of being infected with HIV.

You have been treated with ribociclib before.

You have had another type of cancer within the past 3 years, except for certain types of skin cancer or cervical cancer that has been successfully treated.

Treatment Details

Interventions

• Ribociclib (CDK4/6 Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Administration of ribociclib Experimental Treatment 1 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 Canada, Japan, Switzerland for the following indications:

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

Who Is Running the Clinical Trial?

Nader Sanai

Lead Sponsor

Trials

11

Recruited

440+

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

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

Trials

12

Recruited

910+

Barrow Neurological Institute

Collaborator

Trials

27

Recruited

7,100+