search
Back to results

Abemaciclib in Newly Diagnosed Meningioma Patients

Primary Purpose

Meningioma

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Abemaciclib
Placebo
Sponsored by
Nader Sanai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant with an intracranial WHO Grade 3 meningioma or lower grade meningioma that has progressed to WHO grade 3 that have received prior radiation therapy. Resected tissue must demonstrate: (a) RB positivity on immunohistochemistry (IHC); or, no RB mutations on next-generation sequencing (NGS). A washout period of 14 to 35 days is required between end of RT and Day 1 and must be fully recovered from the acute effects of RT. Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable). Participant has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Participant must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures. Age ≥18 years at time of consent. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale. Ability to swallow oral medications. Participant has adequate bone marrow and organ function Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause. For females of reproductive potential: use of highly effective contraception during study participation and for an additional 3 weeks after the end of treatment administration. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 3 weeks after the end of treatment administration. Exclusion Criteria: Prior history of cancer with ongoing treatment of disease. Current use of coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed. Pregnancy, breastfeeding or lactation. Known allergic reactions to components of the abemaciclib. Active infection or fever >38.5°C requiring systemic antibiotic, antifungal or antiviral therapy within 4 weeks of Day 1. Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis. Known active systemic bacterial infection, fungal infection, or detectable viral infection . Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study. Prior therapy with any CDK4/6 inhibitor. Treatment with another investigational drug within 5 half-lives of the investigational product. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.

Sites / Locations

  • St. Joseph's Hospital and Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Treatment (Abemaciclib)

Placebo

Arm Description

Administered twice daily on days 1-28 of each 28-day cycle.

Administered twice daily on days 1-28 of each 28-day cycle.

Outcomes

Primary Outcome Measures

Progression-free survival
Progression free survival (PFS24) rate measured from the time of surgery to date of recurrence

Secondary Outcome Measures

Drug-related toxicity
Incidence of drug-related toxicity
Adverse Events
Number of adverse events through study completion
Deaths
Number and incidence of deaths
Incidence of clinical laboratory abnormalities per CTCAE
Clinical laboratory abnormalities per CTCAE
Progression-free survival in participants
12 month progression-free survival (PFS12) rate measured from the time of surgery to date of recurrence.
Overall Survival
Overall survival at 24 months
Median Overall Survival
Median overall survival

Full Information

First Posted
July 4, 2023
Last Updated
September 15, 2023
Sponsor
Nader Sanai
Collaborators
Eli Lilly and Company, Barrow Neurological Institute, Ivy Brain Tumor Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05940493
Brief Title
Abemaciclib in Newly Diagnosed Meningioma Patients
Official Title
A Phase 2 Multicenter, Double-blind, Randomized-controlled Study of Abemaciclib (CDK4 and 6 Inhibitor) in Newly Diagnosed RB-proficient Grade 3 Meningioma Participants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
June 30, 2031 (Anticipated)
Study Completion Date
December 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nader Sanai
Collaborators
Eli Lilly and Company, Barrow Neurological Institute, Ivy Brain Tumor Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is being done to learn about how an investigational drug called abemaciclib works in treating patients with a newly-diagnosed grade 3 meningioma. Abemaciclib is a drug that is approved by the FDA, but not for brain tumors. Participants who consent to the trial will have surgical tissue collected from the planned surgical resection and tested. If the tissue shows positive results for RB cells and participants are qualified, they will be enrolled and receive study treatment two to five weeks after completing standard-of-care radiation therapy. This is a randomized clinical trial which means that participants will be randomly assigned to a treatment based on chance, like a flip of a coin. Neither the participant nor the researcher chooses the assigned group. Randomization will help the researchers study how the drug works by comparing the difference between the study drug and the placebo and how they work in treating brain tumors. This is a double-blinded study, which means that neither the participant nor the study team will know which treatment the participant is receiving.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All site study personnel, except the unblinded dispenser and verifier, will be aware of whether participants are receiving abemaciclib or placebo until the study is formally unblinded.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment (Abemaciclib)
Arm Type
Experimental
Arm Description
Administered twice daily on days 1-28 of each 28-day cycle.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered twice daily on days 1-28 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Abemaciclib placebo
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Progression free survival (PFS24) rate measured from the time of surgery to date of recurrence
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Drug-related toxicity
Description
Incidence of drug-related toxicity
Time Frame
Up to 30 days after last study dose
Title
Adverse Events
Description
Number of adverse events through study completion
Time Frame
Up to 30 days after last study dose
Title
Deaths
Description
Number and incidence of deaths
Time Frame
24 months
Title
Incidence of clinical laboratory abnormalities per CTCAE
Description
Clinical laboratory abnormalities per CTCAE
Time Frame
Up to 30 days after last study dose
Title
Progression-free survival in participants
Description
12 month progression-free survival (PFS12) rate measured from the time of surgery to date of recurrence.
Time Frame
12 months
Title
Overall Survival
Description
Overall survival at 24 months
Time Frame
24 months
Title
Median Overall Survival
Description
Median overall survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant with an intracranial WHO Grade 3 meningioma or lower grade meningioma that has progressed to WHO grade 3 that have received prior radiation therapy. Resected tissue must demonstrate: (a) RB positivity on immunohistochemistry (IHC); or, no RB mutations on next-generation sequencing (NGS). A washout period of 14 to 35 days is required between end of RT and Day 1 and must be fully recovered from the acute effects of RT. Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable). Participant has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Participant must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures. Age ≥18 years at time of consent. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale. Ability to swallow oral medications. Participant has adequate bone marrow and organ function Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause. For females of reproductive potential: use of highly effective contraception during study participation and for an additional 3 weeks after the end of treatment administration. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 3 weeks after the end of treatment administration. Exclusion Criteria: Prior history of cancer with ongoing treatment of disease. Current use of coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed. Pregnancy, breastfeeding or lactation. Known allergic reactions to components of the abemaciclib. Active infection or fever >38.5°C requiring systemic antibiotic, antifungal or antiviral therapy within 4 weeks of Day 1. Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis. Known active systemic bacterial infection, fungal infection, or detectable viral infection . Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study. Prior therapy with any CDK4/6 inhibitor. Treatment with another investigational drug within 5 half-lives of the investigational product. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivy Research Navigator
Phone
602-406-8605
Email
research@ivybraintumorcenter.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nader Sanai, MD
Organizational Affiliation
Ivy Brain Tumor Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Navigator
Phone
602-406-8605
Email
research@ivybraintumorcenter.org
First Name & Middle Initial & Last Name & Degree
Nader Sanai, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Abemaciclib in Newly Diagnosed Meningioma Patients

We'll reach out to this number within 24 hrs