EUCTR2019-002115-26-FR进行中（未招募）1 期
Cetuximab as salvage therapy in patients with neo wild-type RAS/RAF metastatic colorectal cancer. A Proof-of-concept study - CETIDY
Institut Hospitalier Franco-Britanique0 个研究点目标入组 72 人开始时间: 2019年9月5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
- 72
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
入选标准
- •1.Provision of signed and dated informed consent and stated willingness to comply with all study procedures and availability for the duration of the study,
- •2.Male or female subjects, =18 years of age,
- •3.ECOG performance status (ECOG PS, Appendix 15.1) =2,
- •4.Unresectable metastatic RAS mutant (either KRAS or NRAS tumor gene mutation) colorectal cancer,
- •5.At least one (=1) measurable and/or evaluable liver metastasis,
- •6.Prior therapy (resistant or intolerant) with fluoropyrimidines, oxaliplatin, irinotecan and antiangiogenic agent (ie, bevacizumab and/or aflibercept),
- •7.Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
- •- Hematological status: neutrophils (ANC) =1.5x109/L; platelets =100x109/L; haemoglobin =9g/dL,
- •- Adequate renal function: serum creatinine clearance (MDRD) = 50 mL/min/1,73 m2
- •- Adequate liver function: serum bilirubin =1.5x upper normal limit (ULN), alkaline phosphatase <5xULN, AST and ALT =5xULN,
- •- Adequate serum electrolyte levels (magnesium, potassium, calcium) prior to initiation of study treatment,
- •8.Negative pregnancy test within 7 days prior to initiation of the study drug for female patients of childbearing potential,
- •9.Effective contraception for both male and female subjects if the risk of conception exists
- •10.Registration in a national health care system.
- •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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 72
排除标准
- •1.Known allergy or hypersensitivity reactions to any study drug,
- •2.Women who are pregnant or breastfeeding,
- •3.Inability to comply with study and follow-up procedures as judged by the Investigator,
- •4.Patient with BRAF mutant colorectal cancer
- •5.History of interstitial lung disease
- •6.Treatment with strong CYP3A4-enzyme inducers such as anticonvulsants (phenytoin, phenobarbital or carbamazepine), rifampin, rifabutin and St. John’s wort for patients of cohort #2
- •7.Treatment with strong CYP3A4-enzyme inhibitors (e.g. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) for patients of cohort #2
- •8.Treatment with strong UGT1A inhibitors (e.g. atazanavir, gemfibrozil, indinavir) for patients of cohort # 2
- •9.Patients of cohort #2 with known UGT1A deficiency
- •10.Uncontrolled illness, including but not limited to ongoing bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination/ clinical laboratory finding that leads to a reasonable suspicion of a disease/condition that contraindicates the use of any of investigational drugs that may affect the interpretation of the results, or that may render the subject at high risk of treatment complications.
- •11.Patient with current intestinal obstruction or history of chronic inflammatory bowel disease
研究者
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