EUCTR2019-002834-35-IT进行中（未招募）1 期
Randomized phase II study of PAnitumumab REchallenge followed by REgorafenib versus the reverse sequence in RAS and BRAF WILD-TYPE chemorefractory metastatic colorectal cancer patients. - PARERE
G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST0 个研究点目标入组 214 人开始时间: 2020年10月21日最近更新:
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
- 214
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
- •Age = 18 years.
- •Histologically proven diagnosis of CRC.
- •At least one measurable lesion according to RECIST1.1
- •ECOG PS = 1.
- •mCRC previously treated for metastatic disease with, or not considered candidates for, fluoropyrimidine, oxaliplatin, irinotecan and anti-angiogenic monoclonal antibody (bevacizumab or aflibercept).
- •RAS (codons 12, 13, 59, 61, 117 and 146 of KRAS and NRAS genes) and BRAF (V600E mutation) wt status of primary CRC or related metastasis (local laboratory assessment).
- •Previous first-line anti-EGFR-containing therapy producing at least a partial response or a stable disease = 6 months.
- •At least 4 months elapsed between the end of first-line anti-EGFR administration and screening.
- •At least one line of therapy between the end of first-line anti-EGFR administration and screening.
- •RAS (codons 12, 13, 59, 61, 117 and 146 of KRAS and NRAS genes) and BRAF (V600E mutation) wt status of ct-DNA at screening (central laboratory assessment by means of IdyllaTM ctKRAS-NRAS-BRAF Mutation Test, Biocartis, Inc.).
- •Neutrophils = 1.5 x 109/L, Platelets =100 x 109/L, Hgb = 9 g/dl.
- •Total bilirubin = 1.5 fold the upper-normal limits (UNL), ASAT (SGOT) and/or ALAT (SGPT) = 2.5 x UNL (or <5 x UNL in the case of liver metastases), alkaline phosphatase = 2.5 x UNL (or < 5 x UNL in case of liver metastases).
- •Creatinine clearance = 50 mL/min or serum creatinine = 1.5 x UNL.
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •Previous treatment with regorafenib.
- •Radiotherapy to any site within 4 weeks before the study
- •Untreated brain metastases or spinal cord compression or primary brain tumours.
- •Evidence of bleeding diathesis or coagulopathy.
- •Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.
- •Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
- •Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of study enrolment.
- •Any previous venous thromboembolism = NCI CTCAE Grade 4.
- •History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment.
- •Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
研究者
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