EUCTR2014-000703-26-ES进行中（未招募）1 期
Phase II study of Regorafenib as single agent for the treatment of patients with metastatic colorectal cancer (mCRC) with any RAS or BRAF mutation previously treated with FOLFOXIRI plus bevacizumab. - PREVIUM
Grupo de Tratamiento de los Tumores Digestivos (TTD)0 个研究点开始时间: 2014年4月1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
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.Signing of the informed consent form.
- •2.The patient must be able to understand the information and state expressly his or her desire to take part in the study.
- •3.Age above or equal to 18 years.
- •4.Histologically or cytologically documented adenocarcinoma of the colon or rectum.
- •5.Patients with metastatic colorectal cancer (stage IV) with any RAS or BRAF mutation.
- •6.To have received first-line treatment with bevacizumab in combination with chemotherapy with the three drugs 5FU/LV, irinotecan and oxaliplatin (FOLFOXIRI), and
- •-have had radiological progression of the disease during the first-line treatment, or
- •-have had radiological progression of the disease within a period of less or equal to 6 months after the last dose of first-line treatment, or
- •-have discontinued part or all of the first-line treatment due to toxicity and have had radiological progression of the disease within a period of less or equal to 6 months after the last dose of first-line treatment.
- •The patient will have to have received at least one cycle of bevacizumab in combination with FOLFOXIRI + bevacizumab as part of the first-line treatment.
- •Patients may have received fluoropyrimidine-based adjuvant treatment with or without oxaliplatin.
- •7.Existence of at least one measurable unidimensional lesion using CT or MRI based on the RECIST criteria, version 1.1
- •8.Overall Eastern Cooperative Oncology Group (ECOG) performance less or equal to 1.
- •9.Patient's commitment to compliance with the oral medication throughout the duration of the study
- •10.Life expectancy of at least 3 months
- •11.Adequate bone marrow, renal and hepatic function, defined as:
- •a.Neutrophils above or equal to 1500/mm3
- •b.Platelets above or equal to 100,000/mm3
- •c.Haemoglobin above or equal to 9,0 g/dL
- •d.Serum Creatinine less or equal to 1.5 x LSN
- •e.Bilirubin levels less or equal to 1.5 x LSN
- •f.AST and ALT levels less or equal to 2.5 x ULN (if liver metastases < or equalto 5 x ULN)
- •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 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Prior treatment with regorafenib.
- •2.Assignment prior to treatment during this study. Patients who are permanently withdrawn from participation in the study treatment will not be allowed to return to it.
- •3.Prior or concurrent presence of another neoplastic disease that is different in terms of tumour site and histology of the colorectal cancer in the 5 years prior to the inclusion of the patient in the study, except in situ cervical cancer, superficial bladder carcinoma [Ta (non-invasive), Tis (carcinoma in situ) and T1 (tumour invades lamina propria)] and non-melanoma skin tumours.
- •4.Presence or history of brain metastases or meningeal tumours.
- •5.Major surgery, open biopsy or traumatic injury within 28 days prior to the start of patient treatment with the study medication.
- •6.Extended-field radiotherapy within 4 weeks prior to inclusion or limited-field radiotherapy in the previous 2 weeks. Patients must have recovered from all treatment-related toxicities.
- •7.Pregnant or breastfeeding women. Women of childbearing age must use adequate contraception. Women of childbearing age must have a negative pregnancy test within 7 days prior to starting with the study medication.
- •8.Women of childbearing age and men who wish to take part in the study must agree to use adequate contraception from the signing of the informed consent until at least 3 months after stopping the study medication. The investigator or the person designated by him or her will ensure and advise as to the contraceptive methods that should be used.
- •Appropriate contraceptive methods include abstinence, oral contraceptives, transdermal patches and injections of sustained-release progestin (starting at least 4 weeks before administration of the IMP), double-barrier method: condom or female condom (diaphragm or cervical/vaginal condom) plus spermicide, intrauterine device (IUD), intrauterine system, implant or vaginal ring (in place at least 4 weeks before administration of the IMP) or male partner sterilisation (vasectomy with documentation of azoospermia) prior to inclusion of the woman in the trial if he is the woman's only sexual partner.
- •9.Active congestive heart failure class 2 or higher on the NYHA scale (New York Heart Association).
- •10.Unstable angina (angina symptoms at rest), new-onset angina (having appeared in the past 3 months) or acute myocardial infarction that has occurred in the 6 months prior to starting with the study medication.
- •11.Cardiac arrhythmias that require anti-arrhythmic therapy (only beta blockers and digoxin would be allowed as concomitant medication for these patients).
- •12.Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg) despite proper medical management.
- •13.Patients with phaeochromocytoma.
- •14.Pleural effusion or ascites that cause breathing difficulties (dyspnoea of grade above or equal to 2 of the CTC).
- •15.Venous or arterial thromboembolism or embolic events such as cerebrovascular accidents (including transient ischaemic attacks), deep vein thrombosis or pulmonary thromboembolism that have occurred in the 6 months prior to starting with the study medication.
- •16.Active infection > grade 2 based on the NCI CTC, v. 4.0.
- •17.Human immunodeficiency virus (HIV) infection.
- •18.Active hepatitis B or C, or hepatitis B or C infection that requires treatment with antiviral drugs.
- •19.Patients with mental disorders that require medication.
- •20.History of organ transplants.
- •21.Patients with evidence or hist
研究者
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