Adding senicapoc and perampanel to standard treatment for newly diagnosed glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase 1 trial adds the drugs perampanel and senicapoc to standard therapy for adults newly diagnosed with glioblastoma. Participants who are planned for surgical resection and the Stupp regimen may receive perampanel or senicapoc alone or both, given around the time of surgery and during standard chemoradiation. The study focuses on safety and tolerability, measures drug levels in blood and tumor to determine brain and tumor penetration, and examines effects on tumor biology. Initial dosing and combination tolerability will guide whether further trials are warranted.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older
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:

1. Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy.
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.).

Where it's running

• Aarhus University Hospital, Department of Neurosurgery
  Aarhus, Denmark, Denmark Recruiting

Study contacts

• Study coordinator: Anders R Korshoej, MD, PhD, Associate professor
• Email: andekors@rm.dk
• Phone: (+45) 78450000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.