A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Oral Vismodegib for the Treatment of Basal Cell Carcinoma Preceding Excision by Mohs Micrographic Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 21
- 主要终点
- Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
- •Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
- •Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements
排除标准
- •Prior treatment with vismodegib
- •Known hypersensitivity to any of the study drug excipients
- •Any metastatic basal cell carcinoma
- •Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
- •Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
- •Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
- •Recent, current, or planned participation in another experimental drug study
研究组 & 干预措施
Placebo
Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks.
干预措施: Placebo (Drug)
Vismodegib
Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
干预措施: Vismodegib (Drug)
结局指标
主要结局
Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit
时间窗: Baseline, MMS visit (Week 12-14)
The percent change in target BCC expected surgical defect area was defined as (\[baseline expected surgical defect area - expected surgical defect area at MMS visit\]/ baseline expected surgical defect area) × 100 percent (%) where expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.
次要结局
- Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit(Baseline, MSS Visit (Week 12-14))
- Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit(Baseline, MMS visit (Week 12-14))
- Percentage of Participants With Clinical Response(MMS visit (Week 12-14))
- Percentage of Participants With BCC Recurrence(Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14))
- Percentage of Participants With Skip Area(MMS visit (Week 12-14))