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CDK4/6 Inhibitor

Ribociclib (LEE011) Treatment for Glioblastoma

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

Study 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
  • Glioblastoma
  • Brain Tumor

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

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

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
754 Previous Clinical Trials
1,245,070 Total Patients Enrolled
6 Trials studying Glioblastoma
206 Patients Enrolled for Glioblastoma
Novartis PharmaceuticalsIndustry Sponsor
2,857 Previous Clinical Trials
4,197,804 Total Patients Enrolled
23 Trials studying Glioblastoma
1,689 Patients Enrolled for Glioblastoma
Camilo Fadul, MDPrincipal InvestigatorUniversity of Virginia
3 Previous Clinical Trials
22 Total Patients Enrolled
2 Trials studying Glioblastoma
19 Patients Enrolled for Glioblastoma

Frequently Asked Questions

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~0 spots leftby Apr 2025