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NCT02038218 · ClinicalTrials.gov registry record · Phase 2
Study of 4-Demethyl-4-cholesteryloxycarbonylpenclome (DM-CHOC-PEN) in Patients With Brain Tumors
A Phase 2 study, sponsored by DEKK-TEC.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT02038218 is a Phase 2 study that has completed, run by DEKK-TEC. The registered enrollment target is 29 participants.
The verdict
NCT02038218, a Phase 2 study, has completed, sponsored by DEKK-TEC.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate that has demonstrated antineoplastic activities in patients with advanced cancers - melanoma, lung, breast and glioblastoma multiforme (GBM) involving the CNS during a Phase I study. These findings support the preclinical responses seen in mice bearing intracerebrally implanted human breast and GBM tumor xenografts. Toxicity was acceptable - hyperbilirubinemia (in patients with liver disease and/or liver metastasis). No hematological, renal, cardiovascular, behavioral or cognitive impairment/neurotoxicities were noted during the Phase I human trial or in previous pre-clinical studies. The drug is available for use as a soy bean oil/egg yolk lecithin/glycerin water emulsion; the latter continues to be chemically and biologically stable and safe. Patients with advanced lung, breast and melanoma cancers spread to the CNS and primary CNS malignancies will be eligible for enrollment and treatment, providing the required blood and other eligibility requirements are met. The trial will be 2-tiered - patients with liver involvement vs. non-liver involvement will be treated with different doses of the drug. The trial is open and patients are currently being enrolled and treated with the protocol.
Interventions
- DRUG 4-Demethyl-4-cholestryloxycarbonylpenclomedine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2013-09 |
| Est. Completion | 2020-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02038218
The ClinicalTrials.gov registry entry for NCT02038218 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DEKK-TEC, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 4-Demethyl-4-cholestryloxycarbonylpenclomedine is the first listed.
NCT02038218 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02038218 about?
NCT02038218 is a clinical study titled "Study of 4-Demethyl-4-cholesteryloxycarbonylpenclome (DM-CHOC-PEN) in Patients With Brain Tumors". DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate that has demonstrated antineoplastic activities in patients with advanced cancers - melanoma, lung, breast and glioblastoma multiforme (GBM) involving the CNS during a Phase I study. These findings support the preclinical responses seen...
What is the current status of trial NCT02038218?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2013-09. Estimated completion is 2020-08.
What interventions are being tested in trial NCT02038218?
The interventions under investigation include: 4-Demethyl-4-cholestryloxycarbonylpenclomedine (DRUG).
Who is sponsoring clinical trial NCT02038218?
This trial is sponsored by DEKK-TEC, which has 6 total clinical trials registered on ClinicalTrials.gov.
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