← Back to Search

CDK4/6 Inhibitor

Ribociclib (LEE011) Treatment for Brain Tumor

Phase 1
Waitlist Available
Led By Camilo Fadul, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 1 year, which is expected average length of participation per patient
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This is a single-institution, open-label, early-phase study to assess the ability of ribociclib (LEE011) to inhibit CDK4/CDK6/Rb/E2F signaling and cell proliferation/viability in core and infiltrating tumor tissues obtained from patients with recurrent glioblastoma or anaplastic glioma compared to the baseline/primary pathologic tumor specimen. Abundant preclinical evidence indicates that Rb-deficient cancer cells are resistant to CDK4/6 inhibition and ongoing trials with CDK4/6 inhibitors exclude patients with Rb-deficient tumors. The investigators will evaluate 10 patients with Rb-positive glioblastoma or anaplastic glioma in this study. Given that a minority of glioblastomas ha Rb loss the investigators anticipate enrolling a maximum of 20 patients, to meet our goal of 10 patients with Rb-positive tumors.

Eligible Conditions
  • Brain Tumor
  • Glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 1 year, which is expected average length of participation per patient
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 1 year, which is expected average length of participation per patient for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Inhibition of CDK4/CDK6 Signaling Pathway in Cell Proliferation
Secondary study objectives
Ribociclib Concentration in Plasma
Ribociclib Concentration in Tissues
Ribociclib Safety Profile
+2 more
Other study objectives
Identifying Treatment Induced Changes in Oncogenic Pathways
Ribociclib Concentrations in Cerebrospinal Fluid (CSF)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ribociclib (LEE011) TreatmentExperimental Treatment1 Intervention
Patients will be treated with ribociclib (LEE011) (recommended phase 2 dose of 600 mg/day) for 8-21 days prior to surgery. For preliminary evaluation of efficacy and toxicity, patients with Rb-positive tumors will resume treatment with ribociclib at 14-28 days post-surgery on a schedule of 21 days on, 7 days off in a 28-day cycle. Patients will be treated until unacceptable toxicity is observed, or until disease progression as assessed by radiographic or clinical metrics.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
FDA approved

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
781 Previous Clinical Trials
1,315,667 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,907 Previous Clinical Trials
4,209,633 Total Patients Enrolled
Camilo Fadul, MDPrincipal InvestigatorUniversity of Virginia
3 Previous Clinical Trials
22 Total Patients Enrolled
~0 spots leftby Nov 2025