EUCTR2012-004018-33-DE进行中（未招募）1 期
A Phase II study of the tumour-targeting human F16IL2 monoclonal antibody-cytokine fusion protein in combination with paclitaxel versus paclitaxel alone in patients with Merkel cell carcinoma. - F16IL2 plus paclitaxel in metastatic Merkel cell carcinoma
Philogen S.p.A.0 个研究点目标入组 90 人开始时间: 2012年11月12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
- 90
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
- •Patients with advanced or metastatic Merkel cell carcinoma (MCC) not amenable to surgery and who have not received previous systemic therapy with taxanes; diagnosis of MCC must be histologically confirmed (evaluation of primary lesions or advanced disease) and endorsed by the IMMOMEC central dermatopathology center (central review of diagnosis at the Department of General Dermatology, Medical University of Graz). Patients must be amenable for paclitaxel treatment according to the discretion of the principal investigator;
- •Patients aged >/= 18 = 75 years;
- •ECOG performance status = 1;
- •Patients must have measurable disease including cutaneous and subcutaneous metastases as defined by RECIST v.1.1 criteria [23] or immune related response Criteria (irRC) [24] as assessed by CT or MRI and/or ultrasound within 4 weeks before the first study drug administration.
- •All acute side effects from any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) Grade = 1;.
- •Adequate hematologic, liver and renal function:
- •oAbsolute neutrophil count (ANC) = 1.5 x 10^9/L, platelets = 100 x 10^9/L, haemoglobin (Hb) = 9.0 g/dl
- •oAlkaline phosphatase (AP), alanine aminotransferase (ALT) and/or aspartate aminotransferase = 3 x upper limit of reference range (ULN), and total bilirubin = 2.0 mg/gL unless liver involvement by the tumor, in which case the transaminase levels could be = 5 x ULN
- •oCreatinine = 1.5 ULN or 24 h creatinine clearance = 50 mL/min
- •Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment;
- •If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug;
- •Evidence of a personally signed and dated EC-approved Informed Consent form indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study;
- •Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Life expectancy of less than 3 months;
- •Any previous taxanes therapy;
- •Previous or concurrent CLL patients;
- •Any other malignancy from which the patient has been disease-free for less than 2 years prior to study entry, with the exception of adequately treated and cured cervical carcinoma in situ, basal or squamous cell carcinoma, superficial bladder cancer, or in situ melanoma;
- •Presence of uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study;
- •Presence of known brain metastases;
- •Chronic-active hepatitis B, C, or HIV;
- •Severe cardiovascular disease:
- •oHistory of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris;
- •oHeart insufficiency (> Grade II, New York Heart Association (NYHA) criteria);
- •oIrreversible cardiac arrhythmias requiring permanent medication;
- •oLVEF oUncontrolled hypertension;
- •oIschemic peripheral vascular disease (Grade IIb-IV);
- •Severe rheumatoid arthritis; or other uncontrolled autoimmune disease;
- •Severe diabetic retinopathy;
- •History of allograft or stem cell transplantation;
- •Major trauma including major surgery (e.g. visceral surgery) within 4 weeks of administration of study treatment;
- •Known history of allergy to IL-2, taxanes, cremophor or other intravenously administered human proteins/peptides/antibodies;
- •Pregnancy or breast-feeding. Female patient must agree to use effective contraception, or be surgically sterile or postmenopausal. The definition of effective contraception will be based on the European guideline ICH M3 rev 2.
- •Treatment with an investigational study drug within four weeks before beginning of treatment with F16IL2;
- •Previous treatment with monoclonal antibodies for biological therapy in the four weeks before administration of study treatment;
- •Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
研究者
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