EUCTR2019-001328-36-IT进行中（未招募）1 期
Multicenter prospective single-arm study investigating the efficacy and safety of second-line cetuximab plus chemotherapy treatment in initially RAS-mt mCRC patients who converted to RAS-wt at the time of first progression - KAIROS
MBERTO I - POLICLINICO DI ROMA0 个研究点目标入组 112 人开始时间: 2021年5月24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
- 112
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
- •- Histologically proven diagnosis of colorectal adenocarcinoma;
- •- KRAS/NRAS-mt status of primary colorectal cancer and/or related metastasis; at the time of the initial diagnosis
- •- Radiological evidence of progression of disease (PD) after first-line therapy with chemotherapy plus bevacizumab;
- •- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, vers.1.1);
- •- Male or female, aged > 18 years of age;
- •- ECOG Performance Status = 2;
- •- Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment;
- •Adequate bone marrow function (without hematopoietic growth factor or transfusion support within 14 days prior to study enrollment), including:
- •a. Absolute Neutrophil Count (ANC) ¿1,500/mm3 or ¿1.5 x 109/L.
- •b. Platelets ¿100,000/mm3 or ¿100 x 109/L.
- •c. Hemoglobin ¿9 g/dL (¿5.6 mmol/L).
- •Female patients of childbearing potential must have negative serum pregnancy or
- •urine pregnancy test at screening.
- •Adequate renal function defined by an estimated creatinine clearance ¿30 mL/min
- •according to the Cockcroft-Gault formula as:
- •¿CLCR={[(140–age) × weight)]/(72 x SCR)} × 0.85 (if female), where CLCR
- •(creatinine clearance) is measured in mL/min, age is expressed in years, weight in
- •kilograms (kg), and SCR (serum creatinine) in mg/dL;
- •¿Or as measured by 24h urine assessment.
- •Adequate liver function, including:
- •a. Total serum bilirubin ¿1.5 × the upper limit of normal range (ULN);
- •b. Aspartate and Alanine aminotransferase (AST and ALT) ¿2.5 x ULN.
- •- Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive;
- •- Subjects and their partners must be willing to avoid pregnancy during the trial and until 6 months after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as approved by the investigator, such as a two-barrier method or one-barrier method with spermicidal or intrauterine device. This requirement begins 2 weeks before receiving the first trial treatment and ends 6 months after receiving the last treatment;
- •- Signed informed consent obtained before any study specific procedures.
- •- KRAS/NRAS-wt status, tested on ctDNA, at the time of progression after first line treatment
- •- Life expectancy of at least 3 months;
- •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 41
排除标准
- •- Active uncontrolled infections or active disseminated intravascular coagulation;
- •- Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix;
- •- Fertile women (<12 months after last menstruation) and men of childbearing potential not willing to use effective means of contraception;
- •- Women who are pregnant or are breastfeeding.
- •- Severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
- •- BRAF mutant tumors
- •- Known hypersensitivity to drugs used in this study or to any of the ingredients of these drugs
- •- eligeble potential patients must not be enrolled in clinicl trials which administered study drugs whithin 4 weeks prior to be enrolled in this trial
研究者
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