EUCTR2015-004543-40-IT进行中（未招募）1 期
A SINGLE ARM, PHASE II, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF VISMODEGIB AND RADIOTHERAPY IN PATIENTS WITH HIGH RISK OR LOCALLY ADVANCED BASAL CELL CARCINOMA NOT AMENABLE TO RADICAL SURGERY (VIRGILIO) - VIRGILIO STUDY
IRCCS ISTITUTO CLINICO HUMANITAS0 个研究点目标入组 50 人开始时间: 2018年8月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written, signed informed consent
- •2.Age = 18 years
- •3.Histopathologic confirmation that the lesion is BCC before enrollment
- •4.Patients with high risk of relapse BCC not undergone radical surgery, for which treating physician must consider the disease to be no more operable.
- •5.Clinical features defining high risk of relapse include infiltrative growth margins, size, tumor location, histological subtype (the morpheaform, the sclerosing, the infiltrating, the micronodular and the metatypical subtypes are associated with higher risk of relapse as compared to the risk associated with the superficial and the nodular types), recurrent-refractory tumors (see Table 1), basal cell carcinoma size (largest tumor diameter) = 5 cm for head and neck tumors
- •6.Clinical features for definition of BCC not amenable for radical surgery” include:
- •-BCC that has recurred in the same location after minimum 2 surgical procedures (excluding biopsies) and/or curative resection is deemed unlikely
- •-multifocal BCC or extensive tumors (see table 1) with bleeding or infected areas
- •-anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation)
- •7.Patients with BCCs localized where surgery is technically difficult, or would result in unacceptable tissue destruction
- •8.Patients with a clinical contraindication to surgery
- •9.Previous radiotherapy on other BCC
- •10.Patients with measurable and/or non-measurable disease (as defined by RECIST, v1.1) are allowed
- •11.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •12.Adequate hematopoietic capacity, defined as the following:
- •-Hemoglobin > 8.5 g/dl
- •-Absolute neutrophil count (ANC) = 1500/?L
- •-Platelet count = 75,000/?L
- •13.Adequate hepatic function, defined as the following:
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 times the upper limit of normal (ULN). Total bilirubin = 1.5 × ULN or within 3 × ULN for patients with documented Gilbert syndrome.
- •14. Adequate renal function, defined by calculated serum creatinine clearance (CrCl) = 30 mL/min
- •15.For women of childbearing potential, a negative serum pregnancy test within 7days prior to commencement of dosing is required.
- •16.Women of child-bearing potential must use two methods of acceptable contraception including one highly effective method and a barrier method, as directed by their physician, during treatment and for at least 24 months after completion of study treatment. Highly effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception, or intra-uterine devices). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, and post ovulation methods) and withdrawal are not acceptable methods of contraception (See Appendix B).
- •17. Male patients mustn’t donate sperm while being treated with Vismodegib, and for 2 months after completion of study treatment.
- •18.For male patients with female partners of childbearing potential, agreement to use a condom, even after a vasectomy, during sexual intercourse with female partners while being treated with Vismodegib, and for 2 months after completion of study treatment
- •19.Agreement not t
排除标准
- •1.Inability or unwillingness to swallow capsules
- •2.Inability or unwillingness to comply with study procedures
- •3.Pregnancy or lactation (lactation not allowed for at least 24 months after completion of study treatment)
- •4.Concurrent non–protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, photodynamic therapy, including participation in an experimental drug study)
- •5.Metastatic BCC
- •6.Gorlin Syndrome or any other contraindication to radiotherapy
- •7.Recent (i.e., within the past 28 days prior to enrollment in this study) or current participation in another experimental drug study
- •8.Uncontrolled medical illness, including advanced malignancies, at the discretion of the Investigator
- •9.History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications
- •10.Known hypersensitivity to Vismodegib or any of the excipients
- •11.Patients in treatment with St. John’s Wort (Hypericum perforatum)
研究者
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