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Treatment with MTX110 · 1 trial · 1 indication
Anew neurological deficit will be defined as new cranial neuropathy, change in level of consciousness, motor weakness, gait change or cerebellar finding (ataxia, dysmetria, dysdiadochokinesis) and will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
| Arm | Type | Description |
|---|---|---|
| Treatment with MTX110 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Treatment with MTX110 | DRUG | Patients will undergo surgery for maximum safe tumor resection with simultaneous placement of a ventricular access device (VAD) into the fourth ventricle or posterior fossa tumor resection cavity.The specific ventricular access device that will be placed is Medtronic Reference number 44102, "Medtronic CSF-Ventricular Reservoir Side Inlet, 18 mm.If a patient already has a ventricular access device in place and additional tumor resection is not required, then that patient can proceed with intraventricular chemotherapy infusions after study enrollment. If the patient has metastatic disease in the brain and/or spine without resectable tumor in the posterior fossa, then only catheter and ventricular access device placement will be performed.Enrolled patients will receive 4 infusions per week of panobinostat (MTX110; 0.25 ml of 300 μM = 26.2 μg), per infusion into the ventricular access device for 6 consecutive weeks for a total of 24 infusions. |
Inclusion Criteria: * Diagnosis: Patients with histologically verified medulloblastoma with recurrence or progression involving anywhere in the brain and/or spine. * Patient must have either measurable or evaluable tumor as assessed by MRI of the brain and total spine * An implanted catheter in the...
MTX110 is an investigational drug being studied for the treatment of medulloblastoma, a type of brain tumor. It is delivered by infusion into the fourth ventricle of the brain. The drug is currently in clinical development and has not been approved by regulatory authorities.
MTX110 is a formulation of panobinostat, a histone deacetylase (HDAC) inhibitor. It works by inhibiting HDAC enzymes, which play a role in gene expression and cancer cell growth. This mechanism is being explored for its potential to treat medulloblastoma.
MTX110 is being developed by Biodexa Pharmaceuticals plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol BDRX. The company is conducting clinical research to evaluate the safety and efficacy of this drug in patients with medulloblastoma.
MTX110 is in Phase 1 clinical development. A completed early Phase 1 trial has been conducted to evaluate the drug in patients with recurrent medulloblastoma. As an investigational agent, it is not yet approved for commercial use.
MTX110 has been studied in a completed early Phase 1 clinical trial with the identifier NCT04315064. This trial evaluated the infusion of panobinostat (MTX110) into the fourth ventricle in children and adults with recurrent medulloblastoma. The trial enrolled 2 participants in the United States.
MTX110 is a formulation of panobinostat, meaning panobinostat is the active pharmaceutical ingredient in MTX110. While they share the same active compound, MTX110 is specifically developed for delivery into the fourth ventricle for the treatment of medulloblastoma.