drugset / Trial / NCT04264143

CED of MTX110 Newly Diagnosed Diffuse Midline Gliomas

NCT04264143

Phase 1 Completed 9 enrolled Luca Szalontay Midatech Pharma US Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

The blood brain barrier (BBB) prevents some drugs from successfully reaching the target source. Convection-Enhanced Delivery (CED) is a method of direct infusion of drugs under controlled pressure to the tumor that may reduce systemic side effects of drugs in the patient. The purpose of this Phase I study is to find the maximum tolerated dose of MTX110 (a water-soluble Panobinostat nanoparticle formulation) and Gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor over 9-11 days.

Timeline

Start
2020-03-10
Primary completion
2022-04-25
Completion
2023-11-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Gadolinium Diagnostic / imaging agent Other
Subject Panobinostat Small molecule 30 unknown Other
Subject Panobinostat Small molecule 60 unknown Other
Subject Panobinostat Small molecule 90 unknown Other