Senicapoc and Perampanel for Newly Diagnosed Glioblastoma
ConditionGlioblastoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
senicapoc
DrugSenicapoc (ICA-17043) is a selective blocker of the intermediate-conductance calcium-activated potassium channel KCa3.1.
Perampanel
DrugPerampanel (Fycompa®) is a non-competitive AMPA-receptor antagonist approved for the treatment of focal and generalized tonic-clonic seizures.
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Senicapoc monotherapy (Group 1)Active comparator 1 intervention
Group B: Perampanel monotherapy (Group 2)Active comparator 1 intervention
Group C: Senicapoc and perampanel combination therapy (Group 3)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
First four weeks of treatment2
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.
Time frame
First six weeks of treatmentSecondary outcomes
1
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.
Time frame
From inclusion until 30 days after treatment completion (approximately 150 days total).2
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.
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.3
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.
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.4
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.
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.Other outcomes
1
Peak plasma concentration (Cmax) of senicapoc
Cmax of senicapoc measured in serial blood samples using validated UHPLC-MS/MS methods. Samples are collected at predefined visits throughout the treatment period
Time frame
From Day 0 to ~30 days after last study-drug dose (blood samples at enrollment on Day 0, Days 12-14, Day 14, Days 14-16, Days 35-42, Days 90-100, Days 120-130, and up to 30 days post-treatment).2
Peak plasma concentration (Cmax) of perampanel
Cmax of perampanel measured in serial blood samples using validated HPLC-MS methods. Samples are collected at predefined visits throughout the treatment period.
Time frame
From Day 0 to ~30 days after last study-drug dose (blood samples at enrollment on Day 0, Days 1-3, Days 12-14, Day 14, Days 14-16, Days 35-42, Days 90-100, Days 120-130, and up to 30 days post-treatment).3
Area under the plasma concentration-time curve (AUC) of senicapoc
AUC of senicapoc measured in serial blood samples using validated UHPLC-MS/MS methods. Samples are collected at predefined visits throughout the treatment period.
Time frame
From Day 0 to ~30 days after last study-drug dose (blood samples at enrollment on Day 0, Days 1-3, Days 12-14, Day 14, Days 14-16, Days 35-42, Days 90-100, Days 120-130, and up to 30 days post-treatment).4
Area under the concentration-time curve (AUC) of perampanel
AUC of perampanel measured in serial blood samples using validated HPLC-MS methods. AUC will be estimated using non-compartmental analysis based on predefined serial blood sampling throughout the treatment period.
Time frame
From Day 0 to ~30 days after last study-drug dose (blood samples at enrollment on Day 0, Days 1-3, Days 12-14, Day 14, Days 14-16, Days 35-42, Days 90-100, Days 120-130, and up to 30 days post-treatment).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aarhus University Hospital
Lead sponsor
University of Aarhus
Collaborator
University of Copenhagen
Collaborator
Source ClinicalTrials.gov