EUCTR2013-003730-33-IT进行中（未招募）1 期
Phase I-II study of the combination vemurafenib plus PEG-interferon in advanced melanoma patients harboring the V600BRAF mutation - VEMUPLINT
Fondazione Melanoma ONLUS0 个研究点目标入组 48 人开始时间: 2013年10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
- 48
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
- •a)Patients over 18
- •b)Untreated and pretreated (no more than 1 treatment) patients with metastatic melanoma at stage unreseactable IIIb-IV, histologically confirmed, that show V600 type BRAF mutations. Patients eligible for Phase I may have been pretreated with the investigational study treatments.
- •c)Patient with measurable disease by RECIST v 1.1
- •d)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 – 1
- •e)Patients who have successfully completed all the secondary side effects to previous systemic therapy
- •f)Patients with an appropriate hematologic, hepatic and renal functionality, assessed in the 7 days preceding the start of therapy, as well as:
- •Absolute neutrophil count (ANC)> 1.5 X 109 / L
- •Absolute platelet count > 100 X 109 / L
- •Hemoglobin > 9 g/dl
- •Serum creatinine < 1.5 times the normal maximum values or Creatinine Clearance > 50 mL/hr (Cockroft-Gault formula)
- •Transaminase level (AST and ALT) < 2.5 times the normal maximum values
- •Serum bilirubin < 1.5 times the normal maximum values
- •g)Negative pregnancy test performed within 7 days before beginning therapy (premenopausal women)
- •h)Patients of childbearing age (or with partners of childbearing age) must use effective contraception during therapy and for at least 6 months after the effective treatment
- •i)Absence of any psychological, familiar or social condition that may affect compliance with study protocol and scheduled follow-up
- •j)Dated and signed informed consent before any study procedure
- •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 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •a)Presence of symptomatic brain metastases
- •b)Previous malignant cancer during the 2 years preceding the signing of informed consent
- •c)Investigational study treatment within 28 days or 5 half-lives, whichever is longer, preceding the first dose of study treatments in this study
- •d)Pregnancy and/or breast feeding;
- •e)Nausea and vomit refractory to therapy, malabsorption, external biliary shunt, previous bowel resection, which could impair an adequate absorption
- •f)Any of these conditions occurring in the 6 months before the start of Vemurafenib therapy: heart attack, unstable angina and/or severe degree, congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, arterial hypertension not adequately controlled
- •g)History of atrial or ventricular arrhythmia, symptomatic> grade 2 (NCI CTCAE)
- •h)Hystory of retinopathy
- •i)Correct QT interval > 450msec to baseline history of congenital long QT syndrome
- •j)Uncontrolled medical condition among which endocrine disorders (such as hypothyroidism, hyperthyroidism and diabetes mellitus)
- •k)Other severe medical or psychiatric conditions or abnormalities of laboratory tests that may increase the risk associated with study participation or the assumption of Vemurafenib, or that may interfere with the interpretation of study results, which in the judgment of the Investigator can make the patient not eligible for the study
- •l)Unwillingness to practice adequate contraception
- •m)Prior systemic treatment with BRAFi or MEKi, or interferon alpha
研究者
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