CTRI/2015/10/006331Other3 期
A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients with metastatic colorectal cancer
AB Science0 个研究点目标入组 2 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 2
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
入选标准
- •To be eligible the patient must fulfil all the following inclusion criteria:
- •1. Patient with non-resectable metastatic colorectal cancer with histological or cytological
- •documentation of adenocarcinoma of the colon or rectum
- •2. Metastatic disease not amenable to surgical resection with curative intent
- •3. Patient in second line treatment after progression according to RECIST criteria following
- •administration of a standard chemotherapy regimen for treatment of metastatic disease
- •4. Patient with measurable lesions according to RECIST criteria (version 1.1) with spiral CT
- •scan and defined as ³10 mm in longest diameter and 2X the slice thickness for extra nodal lesions and/or >15 mm in short axis diameter for nodal lesions
- •5. Patient eligible for a standard second line therapy with FOLFIRI
- •6. Patient with ECOG <= 2
- •7. Patient with adequate organ function
- •Â· Absolute neutrophils count (ANC) >= 1.5 x 109/L
- •Â· Haemoglobin >= 10 g/dl
- •Â· Platelets (PLT) >= 75 x 109/L
- •Â· AST/ALT <= 3 x ULN (<= 5 x ULN in case of liver metastases)
- •Â· GammaGT <= 2.5 x ULN (<= 5 x ULN in case of liver metastases)
- •Â· Bilirubin <= 1.5 x ULN
- •Â· Normal Creatinine or if abnormal creatinine, creatinine clearance >= 50 mL/min (Cockcroft and Gault formula)
- •Â· Albumin > 1 x LLN
- •Â· Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is >= 1+ on the dipstick, 24
- •hours proteinuria must be < 1.5g/24 hours
- •8. Patient with life expectancy > 3 months
- •9. Female or male patient >= 18
- •10. Patient weight >40 kg and BMI > 18
- •11. Man and woman of childbearing potential, who agree to use two methods (one for the patient
- •and one for the partner) of medically acceptable forms of contraception during the study and
- •for 3 months after the last treatment intake
- •12. Female patient of childbearing potential must have a negative pregnancy test at screening and
- •13. Patient able and willing to comply with study procedures as per protocol
- •14. Patient able to understand, sign, and date the written informed consent form at the screening
- •visit prior to any protocol-specific procedures are performed. If the patient is deemed by the
- •treating physician to be cognitively impaired or questionably impaired in such a way that the
- •ability of the patient to give informed consent is questionable, the designated legal guardian
- •must sign the informed consent.
- •15. Patient able to understand the patient card and to follow the patient card procedures in case of
- •signs or symptoms of severe neutropenia or severe cutaneous toxicity during the first 2 months
- •of treatment.
排除标准
- •1. Patient intolerant to one of these treatments: irinotecan, 5-fluorouracil (5-FU), folinic acid
- •2. More than 1 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 required to receive other therapy than FOLFIRI for second line metastatic colorectal
- •7. Patient with an hepatic involvement > 50%
- •8. Patient with active central nervous system metastasis or history of CNS metastases
- •9. Patient with an active infection (Human immunodeficiency virus infection and/or hepatitis B or C infection â?¦)
- •10. 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
- •11. 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
研究者
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