Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: Placebo-containing MNA; 25 µg doxorubicin-containing MNA; 50 µg doxorubicin-containing MNA; 100 µg doxorubicin-containing MNA; 200 µg doxorubicin-containing MNA
Intervention description: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.; A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.; A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.; A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.; A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: 3+3 Design
Masking: None (Open Label)
Masking description: Placebo
Enrollment: 13.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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).
    

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