Basal Cell Carcinoma
Conditions
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).
Detailed 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.
Interventions
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.
DRUG25 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.
DRUG50 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.
DRUG100 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.
DRUG200 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.
Sponsors
SkinJect, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Placebo
Intervention model description
3+3 Design
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale | 4 weeks | Dose Limiting Toxicity (DLT) in Trial Subjects Assessed by Local Skin Response Grading Scale, 0-4, 4 being the worst dermal response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis | 4 weeks | Complete Response (CR), defined as histological confirmation by central reading of basal cell carcinoma excision in all study participants |
Countries
United States
Contacts
STUDY_DIRECTORGregory Suplick
InClinica, Inc.
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo-containing MNA Placebo
Placebo-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo. | 3 |
| 25 µg Doxorubicin-containing MNA D-MNA's containing 25 µg of doxorubicin hydrochloride
25 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride. | 3 |
| 50 µg Doxorubicin-containing MNA D-MNA's containing 50 µg of doxorubicin hydrochloride
50 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride. | 3 |
| 100 µg Doxorubicin-containing MNA D-MNA's containing 100 µg of doxorubicin hydrochloride
100 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride. | 3 |
| 200 µg Doxorubicin-containing MNA D-MNA's containing 200 µg of doxorubicin hydrochloride
200 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride. | 1 |
| Total | 13 |
Baseline characteristics
| Characteristic | Placebo-containing MNA | 25 µg Doxorubicin-containing MNA | 50 µg Doxorubicin-containing MNA | 100 µg Doxorubicin-containing MNA | 200 µg Doxorubicin-containing MNA | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 5 Participants |
| Age, Continuous | 64.67 years STANDARD_DEVIATION 31.72 | 61.33 years STANDARD_DEVIATION 8.505 | 63.33 years STANDARD_DEVIATION 12.34 | 79 years STANDARD_DEVIATION 6.08 | 67 years | 67.35 years STANDARD_DEVIATION 14.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 1 Participants | 13 Participants |
| Region of Enrollment United States | 3 participants | 3 participants | 3 participants | 3 participants | 1 participants | 13 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 0 / 3 | 1 / 3 | 0 / 3 | 0 / 3 | 1 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 1 |
Outcome results
Primary
Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale
Dose Limiting Toxicity (DLT) in Trial Subjects Assessed by Local Skin Response Grading Scale, 0-4, 4 being the worst dermal response
Time frame: 4 weeks
Population: All evaluable subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo-containing MNA | Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale | Participants with DLTs | 0 participants |
| Placebo-containing MNA | Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale | Participants | 3 participants |
| 25 µg Doxorubicin-containing MNA | Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale | Participants | 3 participants |
| 25 µg Doxorubicin-containing MNA | Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale | Participants with DLTs | 0 participants |
| 50 µg Doxorubicin-containing MNA | Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale | Participants with DLTs | 0 participants |
| 50 µg Doxorubicin-containing MNA | Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale | Participants | 3 participants |
| 100 µg Doxorubicin-containing MNA | Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale | Participants | 3 participants |
| 100 µg Doxorubicin-containing MNA | Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale | Participants with DLTs | 0 participants |
| 200 µg Doxorubicin-containing MNA | Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale | Participants | 1 participants |
| 200 µg Doxorubicin-containing MNA | Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale | Participants with DLTs | 0 participants |
Secondary
Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis
Complete Response (CR), defined as histological confirmation by central reading of basal cell carcinoma excision in all study participants
Time frame: 4 weeks
Population: All evaluable subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-containing MNA | Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis | 1 Participants |
| 25 µg Doxorubicin-containing MNA | Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis | 2 Participants |
| 50 µg Doxorubicin-containing MNA | Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis | 1 Participants |
| 100 µg Doxorubicin-containing MNA | Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis | 1 Participants |
| 200 µg Doxorubicin-containing MNA | Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis | 1 Participants |