EUCTR2018-001210-15-CZ进行中（未招募）1 期
Rational Anti-EGFR therapy Selection for the first-line treatment of patients with metastatic KRAS/NRAS wild type colorectal cancer based on the use of molecular predictor miR-31-5p (RASmiR) - RASmiR
Masarykuv onkologický ústav0 个研究点目标入组 375 人开始时间: 2018年11月19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
- 375
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
- •1.The subject, prior to any study-related procedures, has provided Independent Ethics Committee approved written Informed Consent as per national regulations
- •2.The subject is male or female, aged 18 years or older.
- •3.The subject has histologically confirmed wild type KRAS and NRAS (at least in codons: 12, 13, 59, 61, 117, 146 / both genes) mCRC.
- •4.The subject has metastatic lesion measurable by RECIST 1.1.
- •5.The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and life expectancy > 3 months.
- •6. If subject is female of childbearing potential, subject has documentation of negative pregnancy test prior to enrollment.
- •7. Subject (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 90 days after the last dose of systemic drugs.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1.The subject must not receive prior systemic anticancer treatment in adjuvant administration for colorectal cancer in the previous 6 months.
- •2.Disorders of intestinal patency:
- •a) Acute or sub-acute ileus
- •b) Therapy-insensitive diarrhea of grade G3 and above, especially due to short bowel syndrome
- •3.Patients who at the time of diagnosis of mCRC are indicated for surgical treatment, because their primary tumor and/or metastases are radically resectable.
- •4.The subject has primary Central Nervous System (CNS) malignancies or CNS metastases; exception: subjects with brain metastasis treated with radiotherapy or surgery will be allowed if their ECOG status is 0-1.
- •5.The subject has any of the following hematologic abnormalities:
- •ANC 1,5 x 109/L
- •Platelet count < 100 x 109/L
- •6.The subject has any of the following serum chemistry abnormalities:
- •Total bilirubin > 2.5 x ULN
- •Serum albumin < 20 g/L
- •Calculated creatinine clearance < 30mL/min/1.73m2
- •Proteinuria > 2+; protein greater than 2+ must have 24 hour urine collection
- •7.Cardiovascular disease limiting the overall condition of the patient (PS 2 and above): symptomatic heart failure, uncontrolled hypertension G2 and more (systole> = 140-159 mmHg / diastole> = 90-99 mmHg, or signs of hypertensive crisis), uncontrolled / symptomatic cardiac arrhythmia.
- •8.Acute thromboembolic disease or untreated and/or clinically symptomatic thromboembolic disease occurring 6 months before screening for the study
- •9.Significant bleeding disease of severity> G2 6 months before the first medication in the study.
- •10.Female subject is pregnant or lactating.
- •11.The subject has peripheral neuropathy > Grade 2.
- •12.The subject is participating in another interventional protocol.
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