drugset / Trial / NCT03668847

DM-CHOC-PEN for Brain Tumors in AYA Subjects

NCT03668847 ↗

Phase 2 Completed 20 enrolled DEKK-TEC, Inc.
NaSingle-groupOpen-labelTreatment

Summary

4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not transported out of the brain via Pgp (p-glycoprotein). DM-CHOC-PEN has completed a Phase I Adolescent and Young Adult (AYA) trial in humans, some of which possessed primary and secondary tumors involving the brain. Complete remissions in both primary (astrocytoma, GBM) and metastatic lung cancers were reported. This Phase II trial is closed for adolescent and young adults (AYA) subjects with advanced cancer - brain involvement is required.

Timeline

Start
2019-01-01
Primary completion
2021-08-31
Completion
2021-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject 4-Demethyl-4-cholesteryloxycarbonylpenclomedine Small molecule 75 mg/m2 Intravenous
Subject 4-Demethyl-4-cholesteryloxycarbonylpenclomedine Small molecule 98.7 mg/m2 Intravenous