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.
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
Interventions
Drug | Synonyms | Arms |
---|
Placebo-containing MNA | Placebo | Placebo-containing MNA |
25 µg doxorubicin-containing MNA | 25 µg D-MNA | 25 µg Doxorubicin-containing MNA |
50 µg doxorubicin-containing MNA | 50 µg D-MNA | 50 µg Doxorubicin-containing MNA |
100 µg doxorubicin-containing MNA | 100 µg D-MNA | 100 µg Doxorubicin-containing MNA |
200 µg doxorubicin-containing MNA | 200 µg D-MNA | 200 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
Name | Type | Description | Interventions |
---|
Placebo-containing MNA | Placebo Comparator | Placebo | |
25 µg Doxorubicin-containing MNA | Experimental | D-MNA's containing 25 µg of doxorubicin hydrochloride | - 25 µg doxorubicin-containing MNA
|
50 µg Doxorubicin-containing MNA | Experimental | D-MNA's containing 50 µg of doxorubicin hydrochloride | - 50 µg doxorubicin-containing MNA
|
100 µg Doxorubicin-containing MNA | Experimental | D-MNA's containing 100 µg of doxorubicin hydrochloride | - 100 µg doxorubicin-containing MNA
|
200 µg Doxorubicin-containing MNA | Experimental | D-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: | Completed |
Lead Sponsor: | SkinJect, Inc. |
Last Updated
May 13, 2021