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Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)

Primary Purpose

Basal Cell Carcinoma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Placebo-containing MNA

25 µg doxorubicin-containing MNA

50 µg doxorubicin-containing MNA

100 µg doxorubicin-containing MNA

200 µg doxorubicin-containing MNA

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult males and females, 40+ years in general good health as assessed by the investigator.
BCC (subtype: superficial or nodular) confirmed histologically by diagnostic shave biopsy at the Screening Visit
Primary BCC (i.e., no previous treatment)
Lesion size ≥ 4 mm2 or 2 x 2 mm and ≤ 169 mm2 or 13 x 13 mm
Participant must have no other "clinically significant" abnormal findings in his/her medical history, physical examination or clinical laboratory test results as assessed by the investigator
Negative urine pregnancy at study entry for female of child bearing potential
Men and women of child-producing potential must agree to use adequate contraception according to standard instructions by the investigator until the completion of the study
Participant must to be willing to adhere to the instructions of the investigator and his or her research team
Participant must sign an Informed Consent Form prior to any study specific procedures and entry into the study

Exclusion Criteria:

Evidence of clinically significant, unstable medical conditions as assessed by the investigator
Excisional biopsy performed on the lesion to be treated in this study
Recent therapy(ies) to the BCC treatment area
Recurrent BCC (previously treated) at the site presented for treatment
BCC lesion to be treated is located in an area where excisional biopsy is undesired or aesthetically unacceptable to the participant
Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.
Participant with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix
Concomitant disease requiring systemic immunosuppressive treatment
Genetic skin cancer disorder, e.g., basal cell nevus syndrome
Participant is pregnant or breastfeeding
Treatment with another investigational drug, device, or other intervention within 3 months prior to the Screening Visit
Existing condition or treatment within 3 months prior to the Screening Visit that may have impact on clinical outcome for the treatment of BCC or delay in wound healing from the elliptical excision

Sites / Locations

The Center for Clinical and Cosmetic Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo-containing MNA

25 µg Doxorubicin-containing MNA

50 µg Doxorubicin-containing MNA

100 µg Doxorubicin-containing MNA

200 µg Doxorubicin-containing MNA

Arm Description

Placebo

D-MNA's containing 25 µg of doxorubicin hydrochloride

D-MNA's containing 50 µg of doxorubicin hydrochloride

D-MNA's containing 100 µg of doxorubicin hydrochloride

D-MNA's containing 200 µg of doxorubicin hydrochloride

Outcomes

Primary Outcome Measures

Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale

Dose Limiting Toxicity (DLT) in Trial Subjects Assessed by Local Skin Response Grading Scale, 0-4, 4 being the worst dermal response

Secondary Outcome Measures

Number of Participants With Eradicated Basal Cell Carcinoma as Measured by Histological Analysis

Histological confirmation by central reading by pathologist of basal cell carcinoma eradication in trial participants

Full Information

NCT ID

NCT03646188

First Posted

August 22, 2018

Last Updated

August 16, 2022

Sponsor

SkinJect, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03646188

Brief Title

Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)

Official Title

An Open-Label Dose Escalation Trial to Evaluate Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Safety, and Tolerability of Microneedle Arrays Containing Doxorubicin (D-MNA) in Participants With Basal Cell Carcinoma (BCC)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

Application of arrays was inconsistent.

Study Start Date

June 10, 2020 (Actual)

Primary Completion Date

March 1, 2021 (Actual)

Study Completion Date

May 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SkinJect, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Detailed Description

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). Doxorubicin is a cytotoxic anthracycline antibiotic and is currently approved for the treatment of a broad range of cancers, including but not limited to: breast, bladder, gastric, and ovarian cancers; small cell lung cancer; acute lymphoblastic leukemia; and acute myelo blastic leukemia. SkinJect, Inc. has developed a novel delivery system in the form of a tip-loaded dissolvable microneedle array (MNA) which will allow for topical delivery of doxorubicin directly to the lesion at concentrations that are far below standard systemic dosing, thereby reducing the adverse events associated with systemic delivery. The primary objective of this investigation is to establish the highest safe and tolerable dose of single applications of D-MNA, one application per week for three weeks in placebo, 25 µg, 50 µg, 100 µg, and 200 µg dose groups in participants with BCC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Basal Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

3+3 Design

Masking

None (Open Label)

Masking Description

Placebo

Allocation

Non-Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo-containing MNA

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

25 µg Doxorubicin-containing MNA

Arm Type

Experimental

Arm Description

D-MNA's containing 25 µg of doxorubicin hydrochloride

Arm Title

50 µg Doxorubicin-containing MNA

Arm Type

Experimental

Arm Description

D-MNA's containing 50 µg of doxorubicin hydrochloride

Arm Title

100 µg Doxorubicin-containing MNA

Arm Type

Experimental

Arm Description

D-MNA's containing 100 µg of doxorubicin hydrochloride

Arm Title

200 µg Doxorubicin-containing MNA

Arm Type

Experimental

Arm Description

D-MNA's containing 200 µg of doxorubicin hydrochloride

Intervention Type

Drug

Intervention Name(s)

Placebo-containing MNA

Other Intervention Name(s)

Placebo

Intervention Description

A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.

Intervention Type

Drug

Intervention Name(s)

25 µg doxorubicin-containing MNA

Other Intervention Name(s)

25 µg D-MNA

Intervention Description

A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.

Intervention Type

Drug

Intervention Name(s)

50 µg doxorubicin-containing MNA

Other Intervention Name(s)

50 µg D-MNA

Intervention Description

A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.

Intervention Type

Drug

Intervention Name(s)

100 µg doxorubicin-containing MNA

Other Intervention Name(s)

100 µg D-MNA

Intervention Description

A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.

Intervention Type

Drug

Intervention Name(s)

200 µg doxorubicin-containing MNA

Other Intervention Name(s)

200 µg D-MNA

Intervention Description

A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.

Primary Outcome Measure Information:

Title

Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale

Description

Dose Limiting Toxicity (DLT) in Trial Subjects Assessed by Local Skin Response Grading Scale, 0-4, 4 being the worst dermal response

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Number of Participants With Eradicated Basal Cell Carcinoma as Measured by Histological Analysis

Description

Histological confirmation by central reading by pathologist of basal cell carcinoma eradication in trial participants

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult males and females, 40+ years in general good health as assessed by the investigator. BCC (subtype: superficial or nodular) confirmed histologically by diagnostic shave biopsy at the Screening Visit Primary BCC (i.e., no previous treatment) Lesion size ≥ 4 mm2 or 2 x 2 mm and ≤ 169 mm2 or 13 x 13 mm Participant must have no other "clinically significant" abnormal findings in his/her medical history, physical examination or clinical laboratory test results as assessed by the investigator Negative urine pregnancy at study entry for female of child bearing potential Men and women of child-producing potential must agree to use adequate contraception according to standard instructions by the investigator until the completion of the study Participant must to be willing to adhere to the instructions of the investigator and his or her research team Participant must sign an Informed Consent Form prior to any study specific procedures and entry into the study Exclusion Criteria: Evidence of clinically significant, unstable medical conditions as assessed by the investigator Excisional biopsy performed on the lesion to be treated in this study Recent therapy(ies) to the BCC treatment area Recurrent BCC (previously treated) at the site presented for treatment BCC lesion to be treated is located in an area where excisional biopsy is undesired or aesthetically unacceptable to the participant Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose. Participant with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix Concomitant disease requiring systemic immunosuppressive treatment Genetic skin cancer disorder, e.g., basal cell nevus syndrome Participant is pregnant or breastfeeding Treatment with another investigational drug, device, or other intervention within 3 months prior to the Screening Visit Existing condition or treatment within 3 months prior to the Screening Visit that may have impact on clinical outcome for the treatment of BCC or delay in wound healing from the elliptical excision

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory Suplick

Organizational Affiliation

InClinica, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

The Center for Clinical and Cosmetic Research

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)

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