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NCT03668847
DM-CHOC-PEN for Brain Tumors in AYA Subjects
Phase 2 trial testing DM-CHOC-PEN in Advanced Cancer in 20 participants. Completed in 30 September 2021.
31 August 2021
Quick facts
| Lead sponsor | DEKK-TEC, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 January 2019 |
| Primary completion | 31 August 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- DM-CHOC-PEN — full drug profile →
Conditions studied
- Advanced Cancer — all drugs for Advanced Cancer →
- Brain Metastases — all drugs for Brain Metastases →
Sponsor
DEKK-TEC, Inc. — full company profile →
Who can join
Adults 15 to 39, any sex, with Advanced Cancer or Brain Metastases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03668847
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other DEKK-TEC, Inc. trials
Trials by the same sponsor.
- NCT03371004 — DM-CHOC-PEN Plus Radiation for Brain Tumors · Phase 1 · completed
- NCT02889445 — A Phase I Trial of DM-CHOC-PEN in Adolescent and Young Adult (AYA) Subjects With Advanced Cancers · no longer available
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03668847 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by DEKK-TEC, Inc.
- Last refreshed: 8 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03668847.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing