GlioblastomaEarly Phase 1SENIPERANCT07284069
Senicapoc and Perampanel for Newly Diagnosed Glioblastoma
A Early Phase 1 study testing senicapoc and Perampanel in people with Glioblastoma, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- senicapoc and Perampanel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2026to 1 Nov 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- 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
- Eligibility for surgical resection and planned postoperative concomitant radiochemotherapy and adjuvant chemotherapy according to the Stupp regimen
- Eligible for safe postponement of surgery for 14 days from enrollment
- Life expectancy > 3 months
- WHO Performance Status ≤ 2.
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- Ability to provide written informed consent.
- Use of validated anti-conception for fertile female participants in concordance with guidelines provided by the Danish health and medicines authority.
- Signed written consent form.
Who cannot join
- Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy.
- Previous treatment with or allergic reaction to perampanel or senicapoc.
- Contraindications for senicapoc or perampanel treatment.
- Previous malignancy with completion of treatment within five years before inclusion, except for basal cell carcinoma.
- Concomitant intake of enzyme-inducing antiepileptic drugs (carbamazepine, phenytoin, phenobarbotal, or primidon).
- Significant co-morbidities, i.e.
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- Significant liver function impairment (ALAT > 210 umol/L for men and > 135 umol/L for women or total bilirubin > 25 umol/L)
- Significant renal impairment (eGFR < 60 mL)
- Coagulopathy (INR > 1.8 or APTT > 57s)
- Thrombocytopenia (platelet count < 100 x 103/μL = 100 x 109/L)
- Neutropenia (ANC < 1.5 x 103/μL = 1.5 x 109/L)
- Anemia (Hb < 10 g/L = 6.0 mmol/l)
- Severe cognitive impairment.
- Active participation in another therapeutic interventional clinical trial.
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital, Department of Neurosurgery
Aarhus, Denmark, 8200
Anders R Korshoej, MD, PhD, Associate Professor, (+45) 78450000, andekors@rm.dk
About this study
Official title: Phase 0/1 Randomized Clinical Trial of SENIcapoc and PERAmpanel Mono- and Combination Therapy of Newly Diagnosed Glioblastoma
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.
Read more
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.
- Conditions
- Glioblastoma
- Being tested
- senicapoc, Perampanel
- Keywords
- glioblastoma, senicapoc, perampanel, early-phase, cancer neuroscience, neuro-oncology, window-of-opportunity trial, pacemaker cells
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senicapocDrug
Senicapoc (ICA-17043) is a selective blocker of the intermediate-conductance calcium-activated potassium channel KCa3.1.
PerampanelDrug
Perampanel (Fycompa®) is a non-competitive AMPA-receptor antagonist approved for the treatment of focal and generalized tonic-clonic seizures.
| Study group | Role | What they receive |
|---|---|---|
| Senicapoc monotherapy (Group 1) | Active comparator | 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). Receives: Drug: senicapoc |
| Perampanel monotherapy (Group 2) | Active comparator | 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. Receives: Drug: Perampanel |
| Senicapoc and perampanel combination therapy (Group 3) | Active comparator | 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. Receives: Drug: senicapoc; Drug: Perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerable dose of senicapoc monotherapy (mg)
The primary endpoint of the study's Part A will be the maximum tolerable dose of senicapoc monotherapy (milligrams, first four weeks) when added to standard-of-care therapy.
Measured: First four weeks of treatment
Number of patients in each group (2 and 3) excluded from the study due to intolerability when exposed to perampanel at the lowest dose (2 mg)
The primary endpoint of Part B is the number of patients in each group (2 and 3) excluded from the study due to intolerability when exposed to perampanel at the lowest dose (2 mg) within the first 6 weeks of treatment.
Measured: First six weeks of treatment
Secondary outcomes (6)
Incidence and severity of adverse events
Safety will be measured as the risk of adverse events and serious adverse events in each group, evaluated continuously from inclusion until ~30 days after patient exclusion, graded by Common Terminology Criteria for Adverse Events version 5.0 and tabulated by type, grade, and attribution.
Measured: From inclusion until 30 days after treatment completion (approximately 150 days total).
Overall survival
Overall survival is defined as the time from randomization to death from any cause. Patients still alive at End-of-trial or lost to follow-up will be censored at the date of last contact. End-of-trial is defined as 1 year after the last patient completes treatment in Part B, with an estimated maximum follow-up of approximately 24 months per participant.
Measured: From randomization until death from any cause or End-of-trial (defined as 1 year after the last patient completes treatment in Part B), with an estimated maximum follow-up of approximately 24 months.
Progression-free survival
Progression-free survival is defined as the time from randomization to first documented disease progression according to RANO 2.0 criteria or death from any cause, whichever occurs first. Patients without progression or death at End-of-trial or lost to follow-up will be censored at the date of last contact. End-of-trial is defined as 1 year after the last patient completes treatment in Part B, with an estimated maximum follow-up of approximately 24 months per participant.
Measured: From randomization until first documented disease progression, death from any cause, or End-of-trial (defined as 1 year after the last patient completes treatment in Part B), with an estimated maximum follow-up of approximately 24 months.
Objective response rate
Objective response rate is defined as the proportion of patients achieving complete or partial response according to RANO 2.0 criteria. Response is assessed relative to the postoperative baseline MRI obtained within 48 hours after surgery. Patients without a documented response at End-of-trial or lost to follow-up will be censored at the date of last contact. End-of-trial is defined as 1 year after the last patient completes treatment in Part B, with an estimated maximum follow-up of approximately 24 months per participant.
Measured: From postoperative baseline MRI until documented disease progression or End-of-trial (defined as 1 year after the last patient completes treatment in Part B), with an estimated maximum follow-up of approximately 24 months.
Tumor volume
Tumor volume will be quantified based on manual or semiautomated segmentation of T2 FLAIR hyperintense and T1 contrast-enhancing lesions. Preoperative tumor volumes obtained approximately on day 10-14 will be compared to baseline postoperative MRI volumes obtained within 48 hours after surgery. Postoperative tumor volumes assessed on follow-up MRIs will be compared to this postoperative baseline. Aggregated volumes and volume changes compared to baseline will be reported for each time-point.
Measured: From postoperative baseline MRI (<48h) until radiological progression, death, or End-of-trial (1 year after last patient completes Part B), with an estimated maximum follow-up of ~24 months.
Perampanel dose levels
In Part B, the mean maximum tolerated daily dose of perampanel achieved during the first six weeks of treatment will be recorded for each participant and compared between groups 2 (perampanel monotherapy) and 3 (perampanel + senicapoc).
Measured: First six weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Mar 2026
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two parts enrolling a total of 27-36 patients: 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, University of Copenhagen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284069
- Sponsor's protocol ID
- 2025-522605-37-00
- Other IDs
- 2025-522605-37-00, 2025
- Acronym
- SENIPERA
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data (IPD) and relevant study documents will be shared in accordance with FAIR principles through open-access repositories (e.g., Zenodo.org) after publication of the primary results. Data will include de-identified participant-level information, study protocol, and statistical analysis plan. Access to additional de-identified data may be granted upon reasonable request to the sponsor in compliance with applicable data protection regulations (GDPR) and Danish law.
Publications
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.
PubMed 36097070
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0/1 Randomized Clinical Trial of SENIcapoc and PERAmpanel Mono- and Combination Therapy of Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT07284069
- Acronym / sponsor ID
- SENIPERA / 2025-522605-37-00
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, senicapoc, perampanel, early-phase, cancer neuroscience, neuro-oncology, window-of-opportunity trial, pacemaker cells
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, University of Copenhagen
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study consists of two parts enrolling a total of 27-36 patients: 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.
| Arm | Type | Receives |
|---|---|---|
| Senicapoc monotherapy (Group 1) | Active comparator | Drug: senicapocDose 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). |
| Perampanel monotherapy (Group 2) | Active comparator | Drug: PerampanelPerampanel 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. |
| Senicapoc and perampanel combination therapy (Group 3) | Active comparator | Drug: senicapoc, Drug: PerampanelPatients will receive senicapoc at the maximum tolerable dose defined in Group 1 in Part A, together with perampanel titrated as described for Group 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older
- 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
- Eligibility for surgical resection and planned postoperative concomitant radiochemotherapy and adjuvant chemotherapy according to the Stupp regimen
- Eligible for safe postponement of surgery for 14 days from enrollment
- Life expectancy > 3 months
Key exclusion criteria (15 listed)
- Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy.
- Previous treatment with or allergic reaction to perampanel or senicapoc.
- Contraindications for senicapoc or perampanel treatment.
- Previous malignancy with completion of treatment within five years before inclusion, except for basal cell carcinoma.
- Concomitant intake of enzyme-inducing antiepileptic drugs (carbamazepine, phenytoin, phenobarbotal, or primidon).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| senicapocSenicapoc (ICA-17043) is a selective blocker of the intermediate-conductance calcium-activated potassium channel KCa3.1. | Drug | Senicapoc and perampanel combination therapy (Group 3), Senicapoc monotherapy (Group 1) |
| PerampanelPerampanel (Fycompa®) is a non-competitive AMPA-receptor antagonist approved for the treatment of focal and generalized tonic-clonic seizures. | Drug | Perampanel monotherapy (Group 2), Senicapoc and perampanel combination therapy (Group 3) |
Primary outcome
Maximum tolerable dose of senicapoc monotherapy (mg)
Time frame: First four weeks of treatment
The primary endpoint of the study's Part A will be the maximum tolerable dose of senicapoc monotherapy (milligrams, first four weeks) when added to standard-of-care therapy.
Number of patients in each group (2 and 3) excluded from the study due to intolerability when exposed to perampanel at the lowest dose (2 mg)
Time frame: First six weeks of treatment
The primary endpoint of Part B is the number of patients in each group (2 and 3) excluded from the study due to intolerability when exposed to perampanel at the lowest dose (2 mg) within the first 6 weeks of treatment.
6 secondary outcomes
Incidence and severity of adverse events
Time frame: From inclusion until 30 days after treatment completion (approximately 150 days total).
Overall survival
Time frame: From randomization until death from any cause or End-of-trial (defined as 1 year after the last patient completes treatment in Part B), with an estimated maximum follow-up of approximately 24 months.
Progression-free survival
Time frame: From randomization until first documented disease progression, death from any cause, or End-of-trial (defined as 1 year after the last patient completes treatment in Part B), with an estimated maximum follow-up of approximately 24 months.
Objective response rate
Time frame: From postoperative baseline MRI until documented disease progression or End-of-trial (defined as 1 year after the last patient completes treatment in Part B), with an estimated maximum follow-up of approximately 24 months.
Tumor volume
Time frame: From postoperative baseline MRI (<48h) until radiological progression, death, or End-of-trial (1 year after last patient completes Part B), with an estimated maximum follow-up of ~24 months.
Perampanel dose levels
Time frame: First six weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 36097070Pan 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.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data (IPD) and relevant study documents will be shared in accordance with FAIR principles through open-access repositories (e.g., Zenodo.org) after publication of the primary results. Data will include de-identified participant-level information, study protocol, and statistical analysis plan. Access to additional de-identified data may be granted upon reasonable request to the sponsor in compliance with applicable data protection regulations (GDPR) and Danish law.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing senicapoc and Perampanel in people with Glioblastoma, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders R Korshoej, MD, PhD, Associate professor ((+45) 78450000, andekors@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerable dose of senicapoc monotherapy (mg) (time frame: First four weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07284069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.