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)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Placebo
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Participant must sign an Informed Consent Form prior to any study specific procedures and entry into the study
排除标准
- •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
- •BCC lesion to be treated is located in an area where excisional biopsy is undesired or aesthetically unacceptable to the participant
- •Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.
- •Participant with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix
- •Concomitant disease requiring systemic immunosuppressive treatment
- •Genetic skin cancer disorder, e.g., basal cell nevus syndrome
- •Participant is pregnant or breastfeeding
- •Treatment with another investigational drug, device, or other intervention within 3 months prior to the Screening Visit
- •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
研究组 & 干预措施
100 µg Doxorubicin-containing MNA
D-MNA's containing 100 µg of doxorubicin hydrochloride
干预措施: 100 µg doxorubicin-containing MNA (Drug)
Placebo-containing MNA
Placebo
干预措施: Placebo-containing MNA (Drug)
200 µg Doxorubicin-containing MNA
D-MNA's containing 200 µg of doxorubicin hydrochloride
干预措施: 200 µg doxorubicin-containing MNA (Drug)
25 µg Doxorubicin-containing MNA
D-MNA's containing 25 µg of doxorubicin hydrochloride
干预措施: 25 µg doxorubicin-containing MNA (Drug)
50 µg Doxorubicin-containing MNA
D-MNA's containing 50 µg of doxorubicin hydrochloride
干预措施: 50 µg doxorubicin-containing MNA (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale
时间窗: 4 weeks
Dose Limiting Toxicity (DLT) in Trial Subjects Assessed by Local Skin Response Grading Scale, 0-4, 4 being the worst dermal response
次要结局
- Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis(4 weeks)