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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05577416




Registration number
NCT05577416
Ethics application status
Date submitted
19/09/2022
Date registered
13/10/2022
Date last updated
10/06/2024

Titles & IDs
Public title
A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma
Scientific title
A Phase 0/2 Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma
Secondary ID [1] 0 0
2022.003
Universal Trial Number (UTN)
Trial acronym
AB-218-IIT-201
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Biopsy
Treatment: Drugs - Part A: Safusidenib Erbumine
Treatment: Surgery - Surgery (maximal resection)
Treatment: Drugs - Part B: Safusidenib Erbumine

Experimental: Safusidenib Erbumine (AB-218) - Part A: Peri-operative treatment (Phase 0); Part B: Post operative adjuvant therapy (phase 2)


Treatment: Surgery: Biopsy
Patients will undergo stereotactic biopsy by craniotomy or burr hole.

Treatment: Drugs: Part A: Safusidenib Erbumine
Part A: Safusidenib Erbumine orally 250 mg BID for 28 days.

Treatment: Surgery: Surgery (maximal resection)
Surgery: Maximal safe resection, within 24 hours of last dose of Safusidenib Erbumine.

Treatment: Drugs: Part B: Safusidenib Erbumine
Part B: Safusidenib Erbumine orally 250 mg BID for 28 days for a minimum of 12, 28-day cycles subject to ongoing documented evidence of clinical benefit, until disease progression or unacceptable toxicity.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 0: Feasibility of Phase 0 study in patient population
Timepoint [1] 0 0
14 months
Primary outcome [2] 0 0
Phase 0: pharmacokinetic analysis of tumour tissue
Timepoint [2] 0 0
4 weeks
Primary outcome [3] 0 0
Phase 0: pharmacokinetic analysis of cerebrospinal fluid (CSF)
Timepoint [3] 0 0
4 weeks
Primary outcome [4] 0 0
Phase 2: Number of Adverse events
Timepoint [4] 0 0
up to 30 days after last study dose
Primary outcome [5] 0 0
Phase 2: Incidence of drug related adverse events
Timepoint [5] 0 0
up to 30 days after last study dose
Primary outcome [6] 0 0
Phase 2: Incidence of dose limiting toxicity
Timepoint [6] 0 0
up to 30 days after last study dose
Secondary outcome [1] 0 0
Phase 0: Incidence of treatment emergent Adverse events
Timepoint [1] 0 0
during 1 cycle of AB-128, prior to maximal resection (4 weeks)
Secondary outcome [2] 0 0
Phase 0: Safety of planned craniotomy and resection after stereotactic biopsy and treatment with AB-218
Timepoint [2] 0 0
30 days after maximal resection
Secondary outcome [3] 0 0
Phase 0: Pharmacodynamic (PD) analysis of AB-218 in tumour
Timepoint [3] 0 0
after maximal resection (4 weeks), at progression (optional)
Secondary outcome [4] 0 0
Phase 0: Pharmacodynamic (PD) analysis of AB-218 in cerebrospinal fluid (CSF)
Timepoint [4] 0 0
after maximal resection (4 weeks), at progression (optional)
Secondary outcome [5] 0 0
Phase 0: Pharmacodynamic (PD) analysis of AB-218 in plasma
Timepoint [5] 0 0
after maximal resection (4 weeks), monthly during treatment, at progression (optional)
Secondary outcome [6] 0 0
Phase 0: anti-tumour activity
Timepoint [6] 0 0
4 weeks
Secondary outcome [7] 0 0
Phase 0: Identify factors that can improve the patient experience quality of the service provided to participants using Research Participant Perception Survey short form (RPPS)
Timepoint [7] 0 0
4 months post op
Secondary outcome [8] 0 0
Phase 2: Identify factors that can improve the patient experience quality of the service provided to participants using Research Participant Perception Survey short form (RPPS)
Timepoint [8] 0 0
4 months post op
Secondary outcome [9] 0 0
Phase 2: anti-tumour activity
Timepoint [9] 0 0
12 weekly until progression

Eligibility
Key inclusion criteria
1. Histologically confirmed LGG or new diagnosis of LGG based on MRI
2. Tumours suitable for biopsy and safe for maximal resection in the opinion of the treating neurosurgeon
3. Patients who in the consensus of the treating neurosurgeon require resection of the brain tumour.
4. Patients who do not require immediate definitive resection of the brain tumour in the opinion of the treating neurosurgeon
5. Measurable and/or evaluable disease as per LGG-RANO criteria
6. Age = 18 years of age.
7. ECOG performance score 0-1
8. Life expectancy of at least 24 months, in the opinion of the investigator
9. Adequate haematological, renal and hepatic function
10. Reproductive and contraception criteria as prescribed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who meet any of the following criteria will be excluded from participation in the study:

1. Patients who require immediate definitive resection due to degree of mass effect or symptoms
2. Multicentric / multifocal tumour
3. Tumour involves cerebellum or brainstem
4. Patients who have undergone surgery for glioma within 24 months of study enrolment
5. Patients who have received prior chemotherapy and / or radiation for a diagnosis of glioma
6. Patients with contraindications to MRI or unwilling to undergo MRI
7. History of central nervous system bleeding as defined by stroke within 6 months before enrolment
8. Evidence of acute intracranial / intra-tumoural haemorrhage, except for participants with stable grade 1 haemorrhage
9. Other general criteria including:

i) ECG abnormalities ii) significant comorbidity or infection iii) Prior malignancy iv) Recent surgery v) Known allergy or sensitivity to any of the excipients in the investigational product vi) no contraindicated concomitant medications
10. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to participant safety or interfere with the study evaluation, procedures or completion

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Walter and Eliza Hall Institute of Medical Research
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
AnHeart Therapeutics Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05577416
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kate Drummond, Prof
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kate Drummond, Prof
Address 0 0
Country 0 0
Phone 0 0
+61 3 9345 2767
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05577416