drugset / Trial / NCT03668847
DM-CHOC-PEN for Brain Tumors in AYA Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 4-Demethyl-4-cholesteryloxycarbonylpenclomedine | Small molecule | 75 mg/m2 | Intravenous |
| Subject | 4-Demethyl-4-cholesteryloxycarbonylpenclomedine | Small molecule | 98.7 mg/m2 | Intravenous |