Senicapoc and Perampanel for Newly Diagnosed Glioblastoma
NCT ID: NCT07284069
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
36 participants
INTERVENTIONAL
2026-02-01
2028-11-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Part A is an initial dose-escalation phase (3+3 design) to determine the maximum tolerated dose of senicapoc when added to standard-of-care therapy.
Following completion of Part A, Part B is conducted as a randomized, parallel-group phase in which patients are assigned 1:1 to receive standard-of-care therapy plus perampanel monotherapy or standard-of-care therapy plus the combination of perampanel and senicapoc at the established maximum tolerated dose.
TREATMENT
NONE
Study Groups
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Senicapoc monotherapy (Group 1)
Dose escalation will follow a conventional 3 + 3 design to establish the maximum tolerated dose of senicapoc monotherapy, starting at the lowest dose level (DL 1) and proceeding stepwise according to observed dose-limiting toxicities. The maximum tolerable dose is defined as the highest dose level at which fewer than two of six patients experience a dose-limiting toxicity during the first four weeks of treatment. Senicapoc will be administered orally twice daily from the day of inclusion (Days 1-2) and continued until 30 days after completion of radiochemotherapy (approximately day 120-130).
senicapoc
Senicapoc (ICA-17043) is a selective blocker of the intermediate-conductance calcium-activated potassium channel KCa3.1.
Perampanel monotherapy (Group 2)
Perampanel dose-escalation will begin at 2 mg once daily and increase by 2 mg per week up to a maximum of 10 mg/day, depending on individual tolerability.
Perampanel
Perampanel (Fycompa®) is a non-competitive AMPA-receptor antagonist approved for the treatment of focal and generalized tonic-clonic seizures.
Senicapoc and perampanel combination therapy (Group 3)
Patients will receive senicapoc at the maximum tolerable dose defined in Group 1 in Part A, together with perampanel titrated as described for Group 2.
senicapoc
Senicapoc (ICA-17043) is a selective blocker of the intermediate-conductance calcium-activated potassium channel KCa3.1.
Perampanel
Perampanel (Fycompa®) is a non-competitive AMPA-receptor antagonist approved for the treatment of focal and generalized tonic-clonic seizures.
Interventions
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senicapoc
Senicapoc (ICA-17043) is a selective blocker of the intermediate-conductance calcium-activated potassium channel KCa3.1.
Perampanel
Perampanel (Fycompa®) is a non-competitive AMPA-receptor antagonist approved for the treatment of focal and generalized tonic-clonic seizures.
Eligibility Criteria
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Inclusion Criteria
2. Presumed GBM as determined by an expert multidisciplinary neuro-oncological tumor board, including participants from neurosurgery, neuro-oncology, neurology, and neuroradiology. The assessment should be based on a whole-brain MRI according to the consensus recommendations for a standardized brain tumor imaging protocol in clinical trials, not older than 4 weeks from the assessment
3. Eligibility for surgical resection and planned postoperative concomitant radiochemotherapy and adjuvant chemotherapy according to the Stupp regimen
4. Eligible for safe postponement of surgery for 14 days from enrollment
5. Life expectancy \> 3 months
6. WHO Performance Status ≤ 2.
7. Ability to provide written informed consent.
8. Use of validated anti-conception for fertile female participants in concordance with guidelines provided by the Danish health and medicines authority.
9. Signed written consent form.
Exclusion Criteria
2. Previous treatment with or allergic reaction to perampanel or senicapoc.
3. Contraindications for senicapoc or perampanel treatment.
4. Previous malignancy with completion of treatment within five years before inclusion, except for basal cell carcinoma.
5. Concomitant intake of enzyme-inducing antiepileptic drugs (carbamazepine, phenytoin, phenobarbotal, or primidon).
6. Significant co-morbidities, i.e.
1. Significant liver function impairment (ALAT \> 210 umol/L for men and \> 135 umol/L for women or total bilirubin \> 25 umol/L)
2. Significant renal impairment (eGFR \< 60 mL)
3. Coagulopathy (INR \> 1.8 or APTT \> 57s)
4. Thrombocytopenia (platelet count \< 100 x 103/μL = 100 x 109/L)
5. Neutropenia (ANC \< 1.5 x 103/μL = 1.5 x 109/L)
6. Anemia (Hb \< 10 g/L = 6.0 mmol/l)
7. Severe cognitive impairment.
7. Active participation in another therapeutic interventional clinical trial.
8. Any condition that might affect the absorption, distribution, metabolism, or excretion of the trial drugs (including malabsorption states as Whipple's disease, short bowel syndrome, etc.).
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
University of Copenhagen
OTHER
Aarhus University Hospital
OTHER
Responsible Party
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Locations
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Aarhus University Hospital, Department of Neurosurgery
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Pan C, Winkler F. Insights and opportunities at the crossroads of cancer and neuroscience. Nat Cell Biol. 2022 Oct;24(10):1454-1460. doi: 10.1038/s41556-022-00978-w. Epub 2022 Sep 12.
Other Identifiers
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2025-522605-37-00
Identifier Type: CTIS
Identifier Source: secondary_id
2025-522605-37-00
Identifier Type: -
Identifier Source: org_study_id