EUCTR2015-004960-12-IT进行中（未招募）1 期
SEQUENTIAL THERAPY WITH VEMURAFENIB AND ELECTROCHEMOTHERAPY FOR IN-TRANSIT MELANOMA METASTASES: A MULTICENTER SINGLE ARM PHASE II CLINICAL PROSPECTIVE STUDY OF THE ITALIAN MELANOMA INTERGROUP (IMI) - Vemuper
INTERGRUPPO MELANOMA ITALIANO0 个研究点目标入组 53 人开始时间: 2021年9月30日最近更新:
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
- 53
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.Histologically confirmed diagnosis of melanoma BRAF V600 mutated with in-transit metastases not amenable to excision and confined to a limb;
- •2.Presence of instrumentally or clinically measurable or evaluable lesions;
- •3.Patients who at the judgement of an expert surgical team are candidate to electrochemotherapy;
- •4.Age > 18 with PS ¿ 2 (ECOG);
- •5.Life expectancy > 6 months;
- •6.Blood tests (hemochromocitometric exam, hepatic and renal function) within the norm or with values not more than 50% above the normal range;
- •7.Absence of metabolic, endocrine or neurological diseases that require continuous drug therapy;
- •8.Absence of other malignant tumors, excluding carcinoma in situ of the cervix and radically resected early skin cancer;
- •9. Staging carried out within 30 days of randomization;
- •10. Geographical accessibility;
- •11. Written informed consent (including the suggested use of contraceptives for premenopausal women).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •1.Patients with locally advanced disease judged not to be suitable for electrochemotherapy;
- •2.Absence of measurable or evaluable lesions;
- •3.Performance Status: ECOG ¿ 3;
- •4.Patients previously treated with a BRAF inhibitor;
- •5.Patients treated with a MEK inhibitor;
- •6.Presence of a concomitant second tumour. Patients with a previous malignancy but without evidence of disease for = 3 years will be allowed to enter the trial;
- •7.Patients with QTc >450 msec on screening ECG, history of congenital long QT syndrome, or uncorrectable electrolytes abnormalities
- •8.Presence of metabolic, endocrine or neurological diseases that require continuous drug therapy;
- •9.Blood tests (hemochromocitometric exam, renal and hepatic function) with values 50% higher or lower than the normal ranges, and/or total bilirubinemia > 2 X ULN;
- •10. Previous or ongoing serious cardiovascular diseases;
- •11. Absence of written informed consent;
- •12.Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent;
- •13.Women who are pregnant or breastfeeding.
研究者
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