RecruitingEarly Phase 1NCT07284069

Senicapoc and Perampanel for Newly Diagnosed Glioblastoma

Phase 0/1 Randomized Clinical Trial of SENIcapoc and PERAmpanel Mono- and Combination Therapy of Newly Diagnosed Glioblastoma


Sponsor

Aarhus University Hospital

Enrollment

36 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Glioblastoma is the most common and aggressive form of brain cancer in adults. Despite surgery, radiotherapy, and chemotherapy, most patients only live about one year after diagnosis. There is an urgent need for new and better treatments. Recent research has shown that glioblastoma cancer cells communicate with surrounding brain cells through electrical signals that help the tumor grow and resist treatment. Two existing drugs, perampanel (used for epilepsy) and senicapoc (previously tested for blood disorders), may block these harmful signals. Laboratory studies suggest that combining these two drugs could slow tumor growth and make cancer cells more sensitive to standard therapy. The SENIPERA trial will test whether perampanel and senicapoc, alone and in combination, are safe and well tolerated when added to standard treatment for newly diagnosed glioblastoma. The study will also measure how well these drugs reach the brain and tumor, and how they affect tumor biology. The study has two parts: Part A: Tests different doses of senicapoc alone to find the maximum tolerable dose. Part B: Randomly assigns patients to receive either perampanel alone or perampanel together with senicapoc. Participants will all receive standard therapy, including surgery, radiochemotherapy, and adjuvant chemotherapy. During surgery, small samples of tumor and fluid will be collected safely to study how the drugs act in the body and how tumor cells respond. Participants will be closely monitored for side effects and followed with regular clinical visits and MRI scans. The trial will take place at Aarhus University Hospital, Denmark, from February 2026 to November 2028 and will enroll 27-36 adult patients. The study aims to identify safe and biologically active treatment combinations that could be tested in larger trials to improve future glioblastoma care.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether two repurposed drugs — senicapoc and perampanel — taken before and alongside standard treatment can slow or stop the growth of glioblastoma, an aggressive brain tumor. **You may be eligible if...** - You are 18 or older - Imaging strongly suggests you have glioblastoma (confirmed by a multidisciplinary tumor board) - You are scheduled for surgical removal followed by the standard combined radiation and chemotherapy regimen - Surgery can safely be delayed by up to 14 days after enrollment - Your life expectancy is more than 3 months - Your general health is rated WHO performance status 2 or lower - You agree to use contraception during the study **You may NOT be eligible if...** - You are not a surgical candidate or not eligible for standard post-op chemoradiation - Surgery cannot be safely delayed for the pre-treatment period - You have other serious health conditions that could interfere with treatment - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsenicapoc

Senicapoc (ICA-17043) is a selective blocker of the intermediate-conductance calcium-activated potassium channel KCa3.1.

DRUGPerampanel

Perampanel (Fycompa®) is a non-competitive AMPA-receptor antagonist approved for the treatment of focal and generalized tonic-clonic seizures.


Locations(1)

Aarhus University Hospital, Department of Neurosurgery

Aarhus, Denmark, Denmark

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NCT07284069


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