Clinical trial · Interventional
Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Application of arrays was inconsistent.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 100 µg doxorubicin-containing MNA | Drug | — | UNRESOLVED |
| 200 µg doxorubicin-containing MNA | Drug | — | UNRESOLVED |
| 25 µg doxorubicin-containing MNA | Drug | — | UNRESOLVED |
| 50 µg doxorubicin-containing MNA | Drug | — | UNRESOLVED |
| Placebo-containing MNA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- PLACEBO_COMPARATOR
- label
- Placebo-containing MNA
- description
- Placebo
- interventionNames
- Drug: Placebo-containing MNA
- type
- EXPERIMENTAL
- label
- 25 µg Doxorubicin-containing MNA
- description
- D-MNA's containing 25 µg of doxorubicin hydrochloride
- interventionNames
- Drug: 25 µg doxorubicin-containing MNA
- type
- EXPERIMENTAL
- label
- 50 µg Doxorubicin-containing MNA
- description
- D-MNA's containing 50 µg of doxorubicin hydrochloride
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available