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NCT02192021 · ClinicalTrials.gov registry record · Phase 1
Micro Needle Array-Doxorubicin (MNA-D) in Patients With Cutaneous T-cell Lymphoma (CTCL)
A Phase 1 study, sponsored by Falo, Louis, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02192021: Completed Phase 1 study, sponsored by Falo, Louis, MD.
NCT02192021 is a Phase 1 study that has completed, run by Falo, Louis, MD. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02192021, a Phase 1 study, has completed, sponsored by Falo, Louis, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The study hypothesis is that in situ MNA-directed chemo-immunotherapy using doxorubicin will kill tumor cells locally and alter the tumor microenvironment to induce durable systemic tumor-specific immunity. The purpose of this study is to test a new method of experimental treatment for CTCL, using small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy agent. The overall goal of this study is to test the safety and effectiveness of these patches. We also want to determine which micro-dose of the drug is the best to achieve the best response. To make sure that we observe the effects of the very low dose of the drug and not the MNA patch itself, we will also use a placebo (a patch without drug in some patients) in addition to the doxorubicin coated patches. We will thoroughly evaluate the skin where the patches are applied. Once the best dose is determined for use in the patch, we will also begin to look at how well the patches work in clearing the skin.
Primary Outcome
A traditional 3 + 3 dose escalation design will be used in 4 dosage cohorts (25 ug, 50 ug, 100 ug, and 200 ug).
Interventions
- DRUG Micro needle array-Doxorubicin (MNA-D)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-03-09 |
| Est. Completion | 2020-12-09 |
| Phase | Phase 1 |
What the finished NCT02192021 record still lists
NCT02192021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Micro needle array-Doxorubicin (MNA-D) is the first listed.
NCT02192021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02192021 about?
NCT02192021 is a clinical study titled "Micro Needle Array-Doxorubicin (MNA-D) in Patients With Cutaneous T-cell Lymphoma (CTCL)". The study hypothesis is that in situ MNA-directed chemo-immunotherapy using doxorubicin will kill tumor cells locally and alter the tumor microenvironment to induce durable systemic tumor-specific immunity. The purpose of this study is to test a new method of experimental treatment for CTCL, using ...
What is the current status of trial NCT02192021?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2016-03-09. Estimated completion is 2020-12-09.
What interventions are being tested in trial NCT02192021?
The interventions under investigation include: Micro needle array-Doxorubicin (MNA-D) (DRUG).
Who is sponsoring clinical trial NCT02192021?
This trial is sponsored by Falo, Louis, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02192021's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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