drugset / Trial / NCT03646188
Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase I study in participants with superficial or nodular Basal Cell Carcinoma (BCC), designed to assess dose limiting toxicities and maximum tolerated dose, efficacy, safety, and tolerability of dissolvable, tip-loaded, microneedle arrays containing doxorubicin (D-MNA).
Timeline
- Start
- 2020-06-10
- Primary completion
- 2021-03-01
- Completion
- 2021-05-04
Outcome
Outcome not reported
Stopped: “Application of arrays was inconsistent.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 25 ug | Topical |
| Subject | Doxorubicin | Other / unclassified | 50 ug | Topical |
| Subject | Doxorubicin | Other / unclassified | 100 ug | Topical |
| Subject | Doxorubicin | Other / unclassified | 200 ug | Topical |