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RecruitingLast updated: 2 February 2024

AB218 gloma (Anheart): This early phase I study is assessing the feasibility of treatment with targeted therapy (AB-218) prior to surgery in people with IDH1 mutated brain cancer (glioma)A Phase 0/2 Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma

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 patients with IDH1 mutated Low Grade Glioma

Cancer

Brain and Spinal Cancers Brain and Spinal

Age

People18 - 40

Phase

I

Trial Acronym

AB218 gloma (Anheart)

More information

Trial Identifiers

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Trial sponsor

Melbourne Health

Scientific Title

A Phase 0/2 Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma

Eligibility

Inclusion

  1. Patients will have a radiological diagnosis of LGG or a previously confirmed LGG and be planned for elective, non-urgent resection of the tumour
  2. Patients who do not require urgent resection for mass effect, cerebral oedema or hydrocephalus in the opinion of the treating neurosurgeon
  3. Tumour size 2 - 5 cm
  4. Measurable and/or evaluable disease as per LGG-RANO criteria
  5. Willing to undergo planned surgical procedures
  6. Routine trial inclusion criteria

    1. Adults ≥ 18 < 40 years of age
    2. ECOG performance score 0 - 1
    3. Life expectancy of at least 24 months
    4. Haematological and renal function as prescribed
    5. Hepatic function with prescribed limits
    6. Reproductive and contraception criteria as prescribed

Exclusion

Patients who meet any of the following criteria will be excluded from participation in the study:

  1. Patients who require urgent resection due to degree of mass effect, oedema, hydrocephalus or symptoms
  2. Patients who have received chemotherapy or radiation for the diagnosis of LGG
  3. Tumour involves cerebellum or brainstem
  4. Routine trial exclusion criteria

    1. Any significant Intracranial bleeding in the opinion of the principal investigator
    2. Prior malignancy
    3. Significant co-morbidity
    4. ECG abnormalities
    5. Recent surgery
    6. 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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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