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Protein Kinase Inhibitor

Multiple Targeted Therapies for Meningioma

Phase 2
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic documentation: histologically proven intracranial meningioma as documented by central pathology review
Molecular documentation: Presence of SMO, PTCH1, NF2, CDKN2A, AKT1, PIK3CA, PTEN mutations, CDKN2A copy number loss, CDK4, CDK6, CCND1, CCND2, CCND3, or CCNE1 copy number gain in tumor sample as documented specifically by the central laboratory, regardless of whether prior genotype testing outside of the central laboratory was performed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying how well vismodegib, FAK inhibitor GSK2256098, and capivasertib work in treating patients with progressive meningioma.

Who is the study for?
This trial is for adults with progressive meningiomas, including those with neurofibromatosis and stable CNS tumors. Participants can have had prior treatments and must have measurable disease growth documented by MRI or CT scans. Specific genetic alterations are required, and there's no limit on the number of previous therapies. Exclusions include uncontrolled gastric ulcers, allergies to similar drugs, certain medication restrictions based on genetics, recent major surgery, uncontrolled hypertension, and recent abdominal complications.Check my eligibility
What is being tested?
The study tests how well four drugs—Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib—work in treating growing or worsening meningiomas. These drugs aim to halt tumor cell growth by blocking enzymes needed for cell proliferation.See study design
What are the potential side effects?
Potential side effects may include digestive issues like ulcers or perforations (especially if pre-existing), allergic reactions to the drug components (for those with a history), blood sugar level changes requiring diabetic status considerations before joining the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor has been confirmed as meningioma by a pathology review.
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My tumor has specific genetic changes identified by a central lab.
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My cancer is visible on scans and has grown or remained after surgery.
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My cancer has grown by 25% or more in less than 25 months.
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My meningioma has grown after radiation, and it's been weeks since my last treatment.
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My cancer can be seen and measured on a scan.
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I have received treatment before.
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I may or may not have had previous medical treatments.
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I have had multiple treatments for my condition.
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I haven't had chemotherapy or experimental treatments in the last 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival (PFS)
Response rate defined as a confirmed complete response (CR) or partial response (PR)
Secondary outcome measures
Incidence of adverse events according to National Cancer Institute CTCAE version 4.0
Overall survival (OS)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm D (abemaciclib)Experimental Treatment1 Intervention
Patients receive abemaciclib PO Q12H. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm C (capivasertib)Experimental Treatment1 Intervention
Patients receive capivasertib PO BID on days 1-4. Treatment repeats every 7 days for up to 1 cycle (28 days) in the absence of disease progression or unacceptable toxicity.
Group III: Arm B (FAK inhibitor GSK2256098)Experimental Treatment1 Intervention
Patients receive FAK inhibitor GSK2256098 PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL JULY 2017)
Group IV: Arm A (vismodegib)Experimental Treatment1 Intervention
Patients receive vismodegib PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL FEBRUARY 2018)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vismodegib
2015
Completed Phase 4
~1880
Capivasertib
2021
Completed Phase 1
~130
Abemaciclib
2019
Completed Phase 2
~1710

Find a Location

Who is running the clinical trial?

Brain Science FoundationUNKNOWN
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,692 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,019 Total Patients Enrolled
1 Trials studying Meningioma
18 Patients Enrolled for Meningioma

Media Library

Abemaciclib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02523014 — Phase 2
Meningioma Research Study Groups: Arm D (abemaciclib), Arm B (FAK inhibitor GSK2256098), Arm A (vismodegib), Arm C (capivasertib)
Meningioma Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT02523014 — Phase 2
Abemaciclib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02523014 — Phase 2
Meningioma Patient Testimony for trial: Trial Name: NCT02523014 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the highest number of participants included in this research endeavor?

"The medical trial requires the enrollment of 124 eligible participants, who can partake from two separate locations: Overlook Hospital in Summit, New jersey and Montefiore Medical Center-Einstein Campus in Bronx, New york."

Answered by AI

Are there any additional research projects that have utilized FAK Inhibitor GSK2256098?

"Currently, 121 clinical trials are actively studying FAK Inhibitor GSK2256098. Of those active studies, 20 have reached Phase 3 status. Although the majority of these investigations take place in Alicante and Pamplona/Iruña, there are 8747 other medical sites conducting this particular trial worldwide."

Answered by AI

What therapeutic purpose does FAK Inhibitor GSK2256098 serve?

"Patients who are at risk for recurrent breast cancer and have already established advance directives may benefit from treatment with the FAK Inhibitor GSK2256098."

Answered by AI

Can members of the public join this research endeavor?

"Per the data provided by clinicaltrials.gov, enrolment for this study is currently underway. The trial was initiated on August 1st of 2015 and latest modified on September 25th 2022."

Answered by AI

Does GSK2256098 present any risks to those taking it as a FAK Inhibitor?

"After careful review, our experts at Power concluded that GSK2256098 should receive a rating of two due to the presence of Phase 2 data indicating safety but no evidence for efficacy."

Answered by AI

Are there any medical institutions conducting this research experiment throughout North America?

"Currently, there are 100 clinical sites enrolling participants in this trial. Certain metropolitan areas such as Summit, Bronx and Cincinnati have dedicated locations but other cities across the United States may also be hosting a site. It is recommended to select the most convenient location for yourself to reduce transportation costs if you join this study."

Answered by AI

Who else is applying?

What state do they live in?
West Virginia
New York
Virginia
Other
How old are they?
65+
18 - 65
What site did they apply to?
Palo Alto Medical Foundation-Sunnyvale
Boca Raton Regional Hospital
Other
University of Virginia Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

I am trying to get into this trial for my disease. I have had two surgeries and two courses of radiation, and hope this therapy helps.
PatientReceived no prior treatments
I had my first meningioma removed when I was 37 (2015). It was 5”x3”x5”. My neurosurgeon believed it had been in me since I was 22/23yrs old. By the time they found it I was catatonic. Did not have a great primary. Was in and out of hospitals and was treated as a psychiatric case. Even with my 9 day in a row migraines no scans were ever done. After the tumor was removed I went back to work as a veterinary nurse and proceeded to have 10 more surgeries on my head. 3 of which were to remove bone due to osteomyelitis. I’ve had 2 prosthetics both of which have failed. The first after 46wks. The 2nd after about 10 days. The second was removed 12/25/2019. I started getting extreme migraines, worse than I could keep up with and pain in my gut like I used to before we had found the original tumor. My pain management doctor recommended I go back my original neurologist I had from when my tumor was removed. He found a regrow in my tumor in the original spot plus a smaller one in falx region. We’ve been doing mris w/contrast every 6 months, but my original neurosurgeon retired and no neurosurgeon in town will touch me or even see me. It has grown larger, I keep getting mixed results from my consults from the mri. I am on Medicaid at this point. I have developed seizures trigeminal neuralgia (but I can’t nevere medications because they make me psychotic)hand tremors, neuropathy in both arms and legs, severe brain fog, loss of bowls, and basically all quality of life. I had to take leave from word in March of 2021 and not been able to work since. I need help, and I have no idea we’re to find it. Most of my doctors say look for studies like these, so I hope I can be apart of your study and help both us.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What information do you need from me?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. University of Virginia Cancer Center: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
2015. "Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02523014.
All > Minnesota > Neurofibromatosis
~6 spots leftby Oct 2024
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