EUCTR2013-000493-30-CZ进行中（未招募）1 期
A prospective, multicentre, open-label, randomized, active-controlled, 3 parallel groups, phase 2 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid, versus masitinib alone, versus Best Supportive Care, in third or fourth line treatment of patients with metastatic colorectal cancer
AB Science0 个研究点目标入组 150 人开始时间: 2015年7月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •INCLUSION CRITERIA
- •1. Patient with non-resectable metastatic colorectal cancer with histological or cytological documentation of adenocarcinoma of the colon or rectum
- •2. Patient in third line or fourth line treatment for metastatic colorectal cancer
- •? in failure of all available therapies : 5FU, irinotecan, oxalplatin +/- bevacizumab, +/- cetuximab, +/- panatumumab or other available combination of chemotherapy
- •? for which treatment by regorafenib is not recommended
- •3. Patient with measurable lesions according to RECIST criteria (version 1.1) with spiral CT scan and defined as ?10 mm in longest diameter and 2X the slice thickness for extra nodal lesions and/or >15 mm in short axis diameter for nodal lesions
- •4. Patient with ECOG = 2
- •5. Patient with adequate organ function
- •? Absolute neutrophils count (ANC) = 1.5 x 109/L
- •? Haemoglobin = 10 g/dL
- •? Platelets (PLT) = 75 x 109/L
- •? AST and ALT = 3 x ULN (= 5 x ULN in case of liver metastases)
- •? Gamma GT = 2.5 x ULN (= 5 x ULN in case of liver metastases)
- •? Bilirubin = 1.5x ULN (= 3xULN in case of liver metastases)
- •? Normal creatinine or if abnormal creatinine, creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
- •? Albuminaemia > 1 x LLN
- •? Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is = 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
- •? For France only: Urea (BUN) = 2 x ULN (Upper Limit Range)
- •? Troponin T < 0.1 ng/mL or Troponin I < 0.35 ng/mL
- •? For US only: Troponin T < ULN (Upper Limit Range) or Troponin I < ULN (Upper Limit Range) (applicable in USA only)
- •6. Patient with life expectancy > 3 months
- •7. Patient weight > 40 kg and BMI > 18 kg/m²
- •8. Female or male patient = 18 years
- •9. Contraception
- •- Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use twoa highly effective methods (one for the patient and one for the partner) of medically acceptable formsmethod of contraception and an acceptable method of contraception by her male partner during the study and for 3 months after the last treatment intake. Acceptable forms of contraception include:
- •- A documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and the use of a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] usedMale patient with spermicidal foam/gel/film/cream/suppository)
- •- Documented tubal ligation (a female sterilization). In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository) should also be used
- •- Double barrier method: Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •- Any other contraceptive method with a documented failure rate of <1% per year
- •- Abstinence when this is in the line with the preferred and usual lifestyle of the patient.
- •? Male patients must use two partner of childbearing potential who agrees to use a highly effective methods (one for the patient and one for the partner) of medically method of contraception and an acceptable forms of contraception during the study and for three months after the last treatment intake. The acceptable methods of contraception are as follows:
- •- Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
- •- Surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method (cond
排除标准
- •1. Prior treatment with masitinib, or any other tyrosine kinase inhibitor for the treatment of malignancy, except regorafenib
- •2. More than 3 prior chemotherapy regimens for metastatic colorectal cancer.
- •3. Pregnant, intent to be pregnant, or nursing female patient
- •4. Patient with any chronic inflammatory bowel disease
- •5. Patient treated for a cancer other than colorectal cancer within five years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ
- •6. Patient with an hepatic involvement > 50%
- •7. Patient with active central nervous system (CNS) metastasis or history of CNS metastases.
- •8. Patient with an active infection (Human immunodeficiency virus infection and/or hepatitis B or C infection …)
- •9. Patient presenting with cardiac disorders defined by at least one of the following conditions:
- •? Patient with recent cardiac history (within 6 months) of:
- •- Acute coronary syndrome
- •- Acute heart failure (class III or IV of the NYHA classification)
- •- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
- •? Patient with cardiac failure class III or IV of the NYHA classification
- •? Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
- •? Syncope without known aetiology within 3 months
- •? Uncontrolled severe hypertension, according to the judgement of the investigator, or symptomatic hypertension
- •? For US only: Uncontrolled hypertension or symptomatic hypertension, where hypertension is defined by systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg and uncontrolled means that SBP lower than 140 mmHg and DBP lower than 90 mmHg are not achieved despite anti-hypertensive drugs, whatever the reason of failure (inadequate treatment, poor compliance, secondary hypertension or resistant hypertension).
- •10. Patient with a history of poor compliance or of drug/alcohol abuse, or excessive alcohol beverage consumption, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
- •11. For US only: Patient presenting with at least one of the following conditions:
- •? Patient with co-existing dermatological disease (e.g. eczema, psoriasis) or history of skin allergy
- •? Patient presenting with oedemas
- •? Patient with chronic diarrhea
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