EUCTR2012-000644-94-FR进行中（未招募）1 期
A randomized phase II trial assessing Sorafenib (Nexavar®) in combination with irinotecan in metastatic colorectal cancer patients with KRAS mutated tumours after failure of all active drugs known to be effective. - NEXIRI 2
Centre Val d’Aurelle - Paul Lamarque0 个研究点目标入组 159 人开始时间: 2012年9月3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
- 159
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
- •-Male or female = 18 years old
- •-Histologically confirmed diagnosis of colorectal cancer
- •-Asymptomatic or resected primary tumor
- •-Metastatic colorectal cancer not eligible for curative surgery
- •-At least one target lesion:
- •- Unidimensionally measurable on cross-sectional imaging
- •- In an area not previously irradiated
- •-Disease progression after failure of active drugs (5-Fu or 5-Fu prodrugs, irinotecan, oxaliplatin, bevacizumab)
- •-WHO performance status = 2
- •-Confirmation of KRAS mutation in codons 12 or 13 in the primary tumor or metastases
- •-Total bilirubin = 1.5 ULN, ALT or AST = 2.5 ULN (or < 5 in case of liver impairment)
- •-Haemoglobin = 10 g/dL, neutrophils = 1,500/mm3, platelets = 100,000/mm3
- •-Amylase and lipase < 1.5 ULN
- •-Serum creatinine = 1.5 ULN
- •-Negative pregnancy test in women of childbearing potential
- •-Use of an effective contraceptive method during the whole treatment and up to 3 months after the completion of treatment
- •-Life expectancy > 3 months
- •-Informed consent signed prior any study specific 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-History of Gilbert’s syndrome
- •-Symptomatic brain metastases or carcinomatous meningitis
- •-Bone-only metastases
- •-History or presence of other cancer within the past 5 years (except curatively treated nonmelanoma skin cancer)
- •-Prior surgery or radiotherapy within 4 weeks before entering the study
- •-Cardiac arrhythmia requiring treatment (except for beta-blockers and digoxin), unstable cardiac disease, myocardial infarction within the previous 6 months, > grade II NYHA heart failure, uncontrolled hypertension
- •-History of epileptic seizures requiring long-term anticonvulsant therapy
- •-History of organ transplantation with use of immunosuppression therapy
- •-Severe bacterial or fungal infection (Grade > 2 NCI-CTCAE v.3.0)
- •-HIV infection
- •-Long-term use of CYP 3A4 enzyme-inducing agents such as rifampicin, St. John's Wort (hypericum perforatum), phenytoin, carbamazepine, phenobarbital, dexamethasone, and ketoconazole
- •-Pregnant or breastfeeding women
- •-Bowel malabsorption or extended bowel resection that could affect the absorption of sorafenib, occlusive syndrom, inability to take oral medications
- •-Inflammatory bowel disease with chronic diarrhea (NCI N+Bethesda = 1.2g)
- •-Participation in another clinical trial 30 days prior to study entry
- •-Concurrent treatment with any other investigational product or anticancer therapy (except for irinotecan or sorafenib)
- •-Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up).
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