ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic … (NCT04737174) | Clinical Trial Compass
WithdrawnPhase 2
ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors
Stopped: Lack of identifiable patients
0Started 2021-03-25
Plain-language summary
Phase 2A single-arm exploratory clinical study in up to 12 adult subjects aged 18 and older with primary glioma, IDH1 mutation, and uncontrolled focal-onset seizure activity to determine the potential efficacy, safety and pharmacokinetics of ES-481 as adjunctive therapy in glioma-associated epilepsy and to assess for potential anti-tumorigenic effects.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects greater than 18 years of age
✓. Subjects with brain tumour-related epilepsy
✓. Subjects with a history of uncontrolled seizures (at least three focal-onset seizure per month over the last 28 days)
✓. Subjects currently being treated with at least one appropriate AED
✓. Subjects who have had a brain MRI performed in the last three months preceding the signing of informed consent
✓. Subjects with primary brain tumour with an IDH1 mutation (to be determined during the screening period)
✓. Subjects with satisfactory hematologic, renal and liver function, as assessed by the Principal Investigator
✓. Subject with a Karnofsky performance scale index (KPD) of \> 70%
Exclusion criteria
✕. Urgent need for surgical intervention
✕. Alanine aminotransferase or aspartate aminotransferase \> 10 times the upper reference limit at the screening visit
✕. Estimated glomerular filtration rate \< 60 mL/min (calculated using the using the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation) at the screening visit
✕. Any haematological National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 Grade ≥ 3 (with the exception of alopecia) at the screening visit
What they're measuring
1
Electroencephalogram Monitoring of epileptiform interictal and seizure discharge
✕. Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhoea, short bowel syndrome, and/or intestinal obstruction
✕. Hypertension that cannot be reduced to normal range with antihypertensive medication (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg)
✕. Concurrent active cancer that requires non-surgical treatment (e.g., chemotherapy, radiotherapy, adjuvant therapy)
✕. History of severe cardiovascular disease: myocardial ischemia or myocardial infarction of Grade 2 or above, poorly controlled arrhythmia (including QTc interval ≥450 ms for men, ≥470 ms for women); according to New York Heart Association standards, Grade 3 or 4 cardiac insufficiency, or colour doppler ultrasound examination of the left ventricular ejection fraction \< 50% as assessed at the screening visit