NCT02667574已完成2 期
Phase II Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC)
University Hospital, Lille34 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2014年11月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 34
- 主要终点
- the change in surgery stages
研究概览
简要总结
Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with locally advanced BCC.
详细描述
Enrolled patients will receive continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg (in accordance with the product SmPC) per administration. One cycle of therapy will be defined as 28 days of treatment. The treatment will be renewed once a month depending on the product tolerance.
The trial will consist of a Screening Period (Day -28 to -1), a Treatment Period (Day 1 to BOR), one End of Treatment Visit, one Surgery Visit and 8 Safety Follow-Up Visits after the last dose of Vismodegib (+/- 5 days). Day 1 of the study will be defined as the first day a patient receives Vismodegib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with BCC, which surgery stage is A, B or C (cf. Appendix 3: Definition of surgery stages), with a diameter ≥ 3cm in zones at intermediate risk of tumor recurrence and a BCC with a diameter of ≥ 2 cm in the zones at higher risk of tumor recurrence. According to the HAS recommendations, two zones are taken into consideration:
- •Zones at intermediate risk of tumor recurrence: forehead, cheek, chin, neck and scalp
- •Zones at higher risk of tumor recurrence: nose and periorificial sites of the cephalic extremity
- •The decision to include the patient in this study should be taken during the Pluridisciplinary Committee Meeting (RCP). During this RCP, the radiotherapy should be considered as an inadequate treatment. (If the radiotherapist is absent during the meeting, his opinion should be documented in the patient's medical record).
- •Written informed consent
- •Age ≥ 18 years old
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2
- •At least one histologically confirmed lesion...
- •Patients with Gorlin syndrome may enroll in this study but must meet the other inclusion criteria
- •Patients with measurable and/or non-measurable disease (as defined by RECIST, v1.1)
- •Adequate organ function, as evidenced by the following laboratory results:
- •Hemoglobin > 8.5 g/dL
- •Granulocyte count ≥ 1000/μL
- •Platelet count ≥ 75,000/μL
- •Aspartate transaminase (AST ) and alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 × ULN or within 3 × ULN for patients with documented Gilbert syndrome
- •Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
- •Women of childbearing potential must use one highly-effective method of contraception and one barrier method of contraception during treatment and for 24 months after the final dose. 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, or intra-uterine devices; refer to Appendix 8 for more details). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, and postovulation methods] and withdrawal are not acceptable methods of contraception.).
- •For male patients with female partners of childbearing potential, agreement top use a condom with spermicide, even after vasectomy, during sexual intercourse with partners while being treated with Vismodegib and for two months after completion of study treatment
- •For male patients, agreement not to donate semen during the study and for 24 months after discontinuation of Vismodegib
- •Agreement not to donate blood or blood products during the study and for at least 24 months after discontinuation of Vismodegib.
- •Life expectancy > 12 weeks
- •Patients covered by a Health Insurance System
排除标准
- •Inability or unwillingness to swallow capsules
- •Patients with BCC situated out of the head or the neck area
- •Pregnancy or lactation
- •Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy or photodynamic therapy
- •Chemotherapy within 4 weeks prior to enrollment
- •Participation in another clinical trial within 4 weeks prior to enrollment
- •Radiotherapy within 6 months prior to enrolment
- •Metastatic BCC
- •Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk from treatment complications.
- •Patients with a rare hereditary problem of galactose intolerance, primary hypolactasia or glucose-galactose malabsorption (according to the product SmPC).
- •Patients unable or unwilling to comply with the protocol requirements
- •Patients in emergency situations
- •Patients kept in detention
研究组 & 干预措施
open-label
Other
Enrolled patients will receive continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg per administration (in accordance with the product SmPC). One cycle of therapy will be defined as 28 days of treatment. The treatment will be renewed once a month depending on the product tolerance
干预措施: ERIVEDGE (Drug)
结局指标
主要结局
the change in surgery stages
时间窗: Between baseline and maximum 10 months of treatment
comparison of the surgery stages before and after the treatment with Vismodegib according to specific surgery stage table
次要结局
- Assessment of treatment toxicity according to NCI-CTC, v4.0(2 months after the surgery and maximum 12 months after the Vismodegib initiation)
- Number of patients with locally advanced BCC with down-staging of surgical procedures with Vismodegib(from 4 to 10 months of treatment)
- Gravity index related to the surgical or functional results (global score)(At maximum 10 months of treatment)
- Quality of life assessment by Skindex-16 questionnaire(At screening, at 3 months, at 6 months of treatment)
- Score of the clinical benefits at BOR(At maximum 10 months of treatment)
- the tumor recurrence rate(at 3 years of follow-up)
- the cytological response by biopsy(from 4 to 10 months of treatment)
研究者
研究点 (34)
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