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

SkinJect

Status and phase: Terminated; Phase 1

Conditions: Basal Cell Carcinoma

Treatments: Drug: Placebo-containing MNA; Drug: 100 µg doxorubicin-containing MNA; Drug: 50 µg doxorubicin-containing MNA; Drug: 25 µg doxorubicin-containing MNA; Drug: 200 µg doxorubicin-containing MNA

Study type: Interventional

Funder types: Industry

Identifiers

NCT03646188

SKNJCT-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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13 participants in 5 patient groups, including a placebo group

Placebo-containing MNA

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo-containing MNA

25 µg Doxorubicin-containing MNA

Experimental group

Description:

D-MNA's containing 25 µg of doxorubicin hydrochloride

Treatment:

Drug: 25 µg doxorubicin-containing MNA

50 µg Doxorubicin-containing MNA

Experimental group

Description:

D-MNA's containing 50 µg of doxorubicin hydrochloride

Treatment:

Drug: 50 µg doxorubicin-containing MNA

100 µg Doxorubicin-containing MNA

Experimental group

Description:

D-MNA's containing 100 µg of doxorubicin hydrochloride

Treatment:

Drug: 100 µg doxorubicin-containing MNA

200 µg Doxorubicin-containing MNA

Experimental group

Description:

D-MNA's containing 200 µg of doxorubicin hydrochloride

Treatment:

Drug: 200 µg doxorubicin-containing MNA