Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Part A: Safusidenib Erbumine, Part B: Safusidenib Erbumine
Safusidenib Erbumine · 1 trial · 1 indication
Number of patients to complete all planned investigations and procedures
Total and unbound AB-218 in tumour tissue
Total and unbound AB-218 in CSF
Number of adverse events (AEs) according to NCI CTCAE v 5
Drug related adverse events
Dose limiting toxicity events
| Arm | Type | Description |
|---|---|---|
| Safusidenib Erbumine (AB-218) | EXPERIMENTAL | Part A: Peri-operative treatment (Phase 0); Part B: Post operative adjuvant therapy (phase 2) |
| Name | Type | Description |
|---|---|---|
| Biopsy | PROCEDURE | Patients will undergo stereotactic biopsy by craniotomy or burr hole. |
| Part A: Safusidenib Erbumine | DRUG | Part A: Safusidenib Erbumine orally 250 mg BID for 28 days. |
| Surgery (maximal resection) | PROCEDURE | Surgery: Maximal safe resection, within 24 hours of last dose of Safusidenib Erbumine. |
| Part B: Safusidenib Erbumine | DRUG | 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. |
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. ...