Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03893487 | Fimepinostat in Treating Brain Tumors in Children and Young Adults | EARLY_PHASE1 | ACTIVE NOT_RECRUITING | 30 | — | — | Aug 7, 2019 | Aug 31, 2027 | Jul 11, 2025 | 19 | United States, Switzerland |
Will be analyzed using descriptive statistics from results of fimepinostat concentrations measured within the tumor tissue collected at the time of a standard of care surgery or biopsy. Within each strata, Simon's two-stage design will be used.
| Arm | Type | Description |
|---|---|---|
| Treatment (fimepinostat, tumor resection) | EXPERIMENTAL | Patients receive fimepinostat by mouth once daily, on Days -2 to 0. Within 2 hours of receiving fimepinostat on Day 0, patients undergo tumor resection or biopsy as part of their standard of care. MAINTENANCE PHASE: Patients receive fimepinostat by mouth, once daily for days 1-5 each week. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for up to 12 months from the time treatment begins. Should patients continue to derive clinical benefit, and not experience excess toxicity or progression, patients can continue to receive drug for up to 24 months or longer pending discussion with study chairs and study sponsor. |
| Name | Type | Description |
|---|---|---|
| Fimepinostat | DRUG | Fimepinostat capsules |
| Therapeutic Conventional Surgery | PROCEDURE | Undergo surgery |
Inclusion Criteria: * Patients must have one of the following histologically confirmed diagnoses (histologic confirmation from initial diagnosis acceptable, as appropriate): * Stratum A: Newly diagnosed diffuse intrinsic pontine glioma (WHO grade II-IV) - this stratum does not require tissue con...