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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 is a Phase 1 study that has completed, run by Falo, Louis, MD. The registered enrollment target is 20 participants.

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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.

Interventions

  • DRUG Micro needle array-Doxorubicin (MNA-D)

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2016-03-09
Est. Completion 2020-12-09
Phase Phase 1

Sponsor

Falo, Louis, MD

2 total trials

What the Registry Record Tells You About NCT02192021

The ClinicalTrials.gov registry entry for NCT02192021 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Falo, Louis, MD, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Micro needle array-Doxorubicin (MNA-D) is the first listed.

NCT02192021 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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