Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Ar… (NCT03646188) | Clinical Trial Compass
TerminatedPhase 1
Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)
Stopped: Application of arrays was inconsistent.
United States13 participantsStarted 2020-06-10
Plain-language 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).
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult males and females, 40+ years in general good health as assessed by the investigator.
✓. BCC (subtype: superficial or nodular) confirmed histologically by diagnostic shave biopsy at the Screening Visit
✓. Primary BCC (i.e., no previous treatment)
✓. Lesion size ≥ 4 mm2 or 2 x 2 mm and ≤ 169 mm2 or 13 x 13 mm
✓. 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
✓. Negative urine pregnancy at study entry for female of child bearing potential
✓. 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
✓. Participant must to be willing to adhere to the instructions of the investigator and his or her research team
Exclusion criteria
✕. Evidence of clinically significant, unstable medical conditions as assessed by the investigator
✕. Excisional biopsy performed on the lesion to be treated in this study
✕. Recent therapy(ies) to the BCC treatment area
✕. Recurrent BCC (previously treated) at the site presented for treatment
What they're measuring
1
Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale