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Open-Label Dose Escalation Trial to Evaluate Dose Limiting Toxicity and Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in BCC

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ClinicalTrials.gov Identifier: NCT03646188
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
SkinJect, Inc.

Study Description
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Brief 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). 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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Drug: Placebo-containing MNA Drug: 25 µg doxorubicin-containing MNA Drug: 50 µg doxorubicin-containing MNA Drug: 100 µg doxorubicin-containing MNA Drug: 200 µg doxorubicin-containing MNA Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 3+3 Design
Masking: None (Open Label)
Masking Description: Placebo
Primary Purpose: Treatment
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)
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo-containing MNA
Placebo
 Drug: Placebo-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.
Other Name: Placebo
Experimental: 25 µg Doxorubicin-containing MNA
D-MNA's containing 25 µg of doxorubicin hydrochloride
 Drug: 25 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.
Other Name: 25 µg D-MNA
Experimental: 50 µg Doxorubicin-containing MNA
D-MNA's containing 50 µg of doxorubicin hydrochloride
 Drug: 50 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.
Other Name: 50 µg D-MNA
Experimental: 100 µg Doxorubicin-containing MNA
D-MNA's containing 100 µg of doxorubicin hydrochloride
 Drug: 100 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.
Other Name: 100 µg D-MNA
Experimental: 200 µg Doxorubicin-containing MNA
D-MNA's containing 200 µg of doxorubicin hydrochloride
 Drug: 200 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.
Other Name: 200 µg D-MNA


Outcome Measures
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Primary Outcome Measures :
  1. Dose limiting toxicity (DLT) and maximum tolerated dose (MTD) [ Time Frame: 4 weeks ]
    Presence or absence of cutaneous reactions to the D-MNA application


Secondary Outcome Measures :
  1. Efficacy as measured by histological analysis [ Time Frame: 4 weeks ]
    Histological confirmation of basal cell carcinoma eradication


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult males and females, 40+ years in general good health as assessed by the investigator.
  2. BCC (subtype: superficial or nodular) confirmed histologically by diagnostic shave biopsy at the Screening Visit
  3. Primary BCC (i.e., no previous treatment)
  4. Lesion size ≥ 4 mm2 or 2 x 2 mm and ≤ 169 mm2 or 13 x 13 mm
  5. 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
  6. Negative urine pregnancy at study entry for female of child bearing potential
  7. 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
  8. Participant must to be willing to adhere to the instructions of the investigator and his or her research team
  9. Participant must sign an Informed Consent Form prior to any study specific procedures and entry into the study

Exclusion Criteria:

  1. Evidence of clinically significant, unstable medical conditions as assessed by the investigator
  2. Excisional biopsy performed on the lesion to be treated in this study
  3. Recent therapy(ies) to the BCC treatment area
  4. Recurrent BCC (previously treated) at the site presented for treatment
  5. BCC lesion to be treated is located in an area where excisional biopsy is undesired or aesthetically unacceptable to the participant
  6. Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.
  7. Participant with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix
  8. Concomitant disease requiring systemic immunosuppressive treatment
  9. Genetic skin cancer disorder, e.g., basal cell nevus syndrome
  10. Participant is pregnant or breastfeeding
  11. Treatment with another investigational drug, device, or other intervention within 3 months prior to the Screening Visit
  12. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646188


Contacts
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Contact: Michael J Fare 2035332050 mfare@skinjectpatch.com

Locations
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United States, Florida
The Center for Clinical and Cosmetic Research Recruiting
Aventura, Florida, United States, 33180
Principal Investigator: Mark Nestor, MD         
Sponsors and Collaborators
SkinJect, Inc.
Investigators
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Study Director: Gregory Suplick InClinica, Inc.
More Information
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Responsible Party: SkinJect, Inc.
ClinicalTrials.gov Identifier: NCT03646188    
Other Study ID Numbers: SKNJCT-001
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Doxorubicin
 Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action