Trial purpose
Cancer treatment
Tumor type
Brain and Spinal
Age
18 - 40
Trial acronym
AB218 gloma (Anheart)
Clinical summary
Summary
Eligible participants will receive treatment in two parts. In Part A, participants will undergo a biopsy, followed by one cycle (28 days) of treatment with AB-218, an orally available, small molecule inhibitor of mutated IDH1, and then a safe maximal resection (surgery) of the tumour. In Part B, following recovery from surgery, participants will receive up to 12 cycles of AB-218.
Conditions
This trial is treating people with IDH1 mutated Low Grade Glioma
Eligibility
Inclusion
- Patients will have a radiological diagnosis of LGG or a previously confirmed LGG and be planned for elective, non-urgent resection of the tumour
- Patients who do not require urgent resection for mass effect, cerebral oedema or hydrocephalus in the opinion of the treating neurosurgeon
- Tumour size 2 - 5 cm
- Measurable and/or evaluable disease as per LGG-RANO criteria
- Willing to undergo planned surgical procedures
-
Routine trial inclusion criteria
- Adults ≥ 18 < 40 years of age
- ECOG performance score 0 - 1
- Life expectancy of at least 24 months
- Haematological and renal function as prescribed
- Hepatic function with prescribed limits
- Reproductive and contraception criteria as prescribed
Exclusion
Patients who meet any of the following criteria will be excluded from participation in the study:
- Patients who require urgent resection due to degree of mass effect, oedema, hydrocephalus or symptoms
- Patients who have received chemotherapy or radiation for the diagnosis of LGG
- Tumour involves cerebellum or brainstem
-
Routine trial exclusion criteria
- Any significant Intracranial bleeding in the opinion of the principal investigator
- Prior malignancy
- Significant co-morbidity
- ECG abnormalities
- Recent surgery
- Known allergy or sensitivity to any of the excipients in the investigational product
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Melbourne Health
Scientific Title
A Phase 0/2 Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma
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