A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma (NCT05577416) | Clinical Trial Compass
CompletedEarly Phase 1
A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma
Australia14 participantsStarted 2022-10-11
Plain-language summary
The aim of this clinical trial is to evaluate the feasibility of undertaking a Phase 0 surgical study in patients with diagnosis of a IDH1 mutated Low Grade Glioma (LGG) who have not received prior radiation or chemotherapy and are planned to undergo surgical resection.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed LGG or new diagnosis of LGG based on MRI
✓. Tumours suitable for biopsy and safe for maximal resection in the opinion of the treating neurosurgeon
✓. Patients who in the consensus of the treating neurosurgeon require resection of the brain tumour.
✓. Patients who do not require immediate definitive resection of the brain tumour in the opinion of the treating neurosurgeon
✓. Measurable and/or evaluable disease as per LGG-RANO criteria
✓. Age ≥ 18 years of age.
✓. ECOG performance score 0-1
✓. Life expectancy of at least 24 months, in the opinion of the investigator
Exclusion criteria
✕. Patients who require immediate definitive resection due to degree of mass effect or symptoms
✕. Multicentric / multifocal tumour
✕. Tumour involves cerebellum or brainstem
✕. Patients who have undergone surgery for glioma within 24 months of study enrolment
✕. Patients who have received prior chemotherapy and / or radiation for a diagnosis of glioma
What they're measuring
1
Phase 0: Feasibility of Phase 0 study in patient population
Timeframe: 14 months
2
Phase 0: pharmacokinetic analysis of tumour tissue
Timeframe: 4 weeks
3
Phase 0: pharmacokinetic analysis of cerebrospinal fluid (CSF)