EUCTR2017-002219-33-IT进行中（未招募）1 期
seconD-line folfiri/aflIbercept in proSpecTIvely stratified, anti-EGFR resistaNt, metastatic coloreCTal cancer patIents with RAS Validated wild typE status - seconD-line folfiri/aflIbercept in proSpecTIvely stratified metastatic coloreCTal cancer patIents
FONDAZIONE GISCAD (GRUPPO ITALIANO PER LO STUDIO DEI CARCINOMI DELL'APPARATO DIGERENTE)0 个研究点目标入组 151 人开始时间: 2021年9月10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
- 151
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
- •Histological confirmation of colorectal cancer
- •Confirmed RAS wild type patient treated with an oxaliplatin-anti EGFR treatment in 1st line
- •At least one lesion measurable with CT or MRI scan
- •Radiologically documented progression while on or after discontinuation of treatment with FOLFOX in combination with an anti-EGFR monoclonal antibody (either cetuximab or panitumumab)
- •Life expectancy ¿ 3 months
- •Netrophils count ³ 1.5 x 109/L
- •Platelets count ³ 100 x 109/L
- •Hemoglobin ³ 9 g/dL
- •Creatinine £ 1.5 mg/dL, Proteinuria <2+ (dipstick urinalysis with reactive stripes or Combur test) or =1g/24hour.Bilirubin £ 1.5 x ULN
- •AST and ALT £ 2.5 x ULN (< 5 ULN in case of liver metastases)
- •Informed written consent
- •ECOG Performance Status < 2
- •Age ¿18 yrs
- •Regular follow-up feasible
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
- •Treatment with any other investigational medicinal product within 28 days prior to First Study treatment.
- •Other serious and uncontrolled non-malignant disease,
- •History or evidence upon physical examination of CNS metastasis unless adequately treated
- •Gilbert’s syndrome
- •Intolerance to atropine sulfate or loperamide
- •Known dihydropyrimidine dehydrogenase deficiency
- •Treatment with CYP3A4 inducers unless discontinued > 7 days prior to First Study treatment.
- •Any of the following in 3 months prior to inclusion: grade 3-4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis.
- •Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years,
- •Major surgery or traumatic injury within the last 28 days or until the surgical wound is fully healed whichever came later
- •Negative test for pregnancy on serum in fertile age executed within 1 week (7 days) befere the starting therapy,
- •Patients with known allergy to any excipient to study drugs,
- •Bowel obstruction.
- •Uncontrolled infections
- •Known drugs or alcohol abuse
- •History of severe cardiovascular disease within 6 months prior to First Study treatment, for example cerebrovascular accidents, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), serious cardiac arrhythmia requiring medication.
- •Uncontrollable hypertension, when treated with three or more drugs.
研究者
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