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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

NCT03646188

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.

Related Conditions:
  • Basal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: SKNJCT-001
  • NCT ID: NCT03646188

Conditions

  • Basal Cell Carcinoma

Interventions

DrugSynonymsArms
Placebo-containing MNAPlaceboPlacebo-containing MNA
25 µg doxorubicin-containing MNA25 µg D-MNA25 µg Doxorubicin-containing MNA
50 µg doxorubicin-containing MNA50 µg D-MNA50 µg Doxorubicin-containing MNA
100 µg doxorubicin-containing MNA100 µg D-MNA100 µg Doxorubicin-containing MNA
200 µg doxorubicin-containing MNA200 µg D-MNA200 µg Doxorubicin-containing MNA

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Placebo-containing MNAPlacebo ComparatorPlacebo
  • Placebo-containing MNA
25 µg Doxorubicin-containing MNAExperimentalD-MNA's containing 25 µg of doxorubicin hydrochloride
  • 25 µg doxorubicin-containing MNA
50 µg Doxorubicin-containing MNAExperimentalD-MNA's containing 50 µg of doxorubicin hydrochloride
  • 50 µg doxorubicin-containing MNA
100 µg Doxorubicin-containing MNAExperimentalD-MNA's containing 100 µg of doxorubicin hydrochloride
  • 100 µg doxorubicin-containing MNA
200 µg Doxorubicin-containing MNAExperimentalD-MNA's containing 200 µg of doxorubicin hydrochloride
  • 200 µg doxorubicin-containing MNA

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:40 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose limiting toxicity (DLT) and maximum tolerated dose (MTD)
Time Frame:4 weeks
Safety Issue:
Description:Presence or absence of cutaneous reactions to the D-MNA application

Secondary Outcome Measures

Measure:Efficacy as measured by histological analysis
Time Frame:4 weeks
Safety Issue:
Description:Histological confirmation of basal cell carcinoma eradication

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:SkinJect, Inc.

Last Updated

June 11, 2020