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临床试验/EUCTR2021-000252-18-FR
EUCTR2021-000252-18-FR招募中1 期

Evaluation of treatment PERSOnalization based on its therapeutic monitoring in patients with metastatic colorectal cancer treated with regorafenib - RePERSO

Rennes University Hospital0 个研究点目标入组 100 人开始时间: 2021年2月18日最近更新:
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试验速览

阶段
1 期
状态
招募中
发起方
入组人数
100
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •-Signed and dated informed consent
  • •-Male or female patients = 18 years-old at time of Informed Consent Form (ICF) signature
  • •-Patients must have a histologically proven metastatic colorectal cancer
  • •-Patients who have previously been treated with standard therapy including a fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab or panitumumab for patients who had a RAS wild-type tumour
  • •-ECOG PS = 0 or 1
  • •-Imaging target greater than one cm must be visible on CT
  • •-Patients must have adequate bone marrow, renal, and hepatic function, as evidenced by the pre-therapeutic check-up performed within 7 days before regorafenib initiation: Normal organ functions as defined below :
  • •a.Absolute neutrophil count = 1.3 Giga/L
  • •b.Platelets > 100 Giga/L
  • •c.Hemoglobin = 9 g/dL
  • •d.Serum creatinine = 1.5 x ULN (Upper Limit of Normal) or Glomerular filtration rate (GFR) =30 ml/min/1.73m2 according to the modified Diet in Renal Disease (MDRD) or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) abbreviated formula
  • •e.AST and ALT =2.5 x ULN (=5.0 × ULN for patients with liver involvement of their cancer)
  • •f.Total Bilirubin =1.5 X ULN OR Direct bilirubin = ULN for patients with total bilirubin levels > 1.5 ULN (except for patients with Gilbert disease for whom a total serum bilirubin = 3ULN is acceptable)
  • •g.Alkaline phosphatase =3 x ULN (=5 x ULN in patient with liver involvement of their cancer and/or with bone metastases). If Alkaline phosphatase > 3 ULN, hepatic isoenzymes 5-nucleotidase or GGT tests must be performed; hepatic isoenzymes 5-nucleotidase must be within the normal range and/or GGT < 1.5 x ULN
  • •h.Lipase =1.5 x ULN
  • •i.No proteinuria: Spot urine < 1+ or more protein in urine or the patient will require a repeat urine analysis. If repeat urinalysis shows 1+ protein or more, a 24-hour urine collection will be required and must show total protein excretion <1000 mg/24 hours
  • •-INR/PTT =1.5 x ULN
  • •-Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care
  • •-Recovery to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) V5.0 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug/procedure related toxicity (except alopecia, anemia, and hypothyroidism)
  • •-Women of childbearing potential and male patients must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy
  • •-Women of childbearing potential must have a negative serum ß-HCG pregnancy test within 7 days prior randomization
  • •-Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
  • •-Patients affiliated to the Social Security 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 100
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •-Prior treatment with regorafenib, and with any prior antiangiogenic inhibitor
  • •-Hypersensitivity to the active substance or to any of the excipients
  • •-Systemic anticancer therapy including cytotoxic therapy, antibodies, immunotherapy =3 weeks prior to start of regorafenib
  • •-Concomitant treatment with a cytochrome P450 3A4 (CYP3A4) inducer or inhibitor or UGT1A9 inhibitor
  • •-Patients unable to swallow oral medication
  • •-Digestive obstruction, chronic inflammatory bowel disease or any malabsorption condition
  • •-Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria])
  • •-Ongoing uncontrolled infection (viral, bacterial or fungal)
  • •-Known history of human immunodeficiency virus (HIV) infection, active or chronic hepatitis B or C
  • •-Breastfeeding
  • •-Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg despite optimal medical management)
  • •-Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication
  • •-Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
  • •-Myocardial infarction less than 6 months before the start of study medication
  • •-Any hemorrhage or bleeding event = Grade 3, NCI-CTCAE v 5.0 within 4 weeks prior to the start of study medication
  • •-Major surgical procedure, open biopsy or significant traumatic injury within 28 days before start of study medication
  • •-Non-healing wound, ulcer or bone fracture
  • •-Unresolved toxicity higher than Grade 1, NCI-CTCAE v 5.0, attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neuropathy
  • •-Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • •-Adults legally protected (judicial protection, guardianship or supervision), person deprived of their liberty

研究者

发起方
Rennes University Hospital

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