EUCTR2008-000973-40-NL进行中（未招募）1 期
A prospective, multicenter, randomized, open-label, active-controlled, , phase III study to compare efficacy and safety of masitinib to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment - AB04030
AB SCIENCE0 个研究点目标入组 450 人开始时间: 2010年12月23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
- 入组人数
- 450
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. Histologically proven, metastatic or locally advanced non resectable,
- •or recurrent post surgery GIST
- •2. Naïve patient or patient previously treated with imatinib as
- •neoadjuvant/adjuvant who relapsed after imatinib discontinuation
- •3. Measurable tumour lesions with longest diameter = 20 mm using
- •conventional techniques or = 10 mm with spiral CT scan according
- •RECIST criteria
- •4. C-Kit (CD117) positive tumours detected by immuno-histochemically or PDGFR positive if c-kit negative
- •5. ECOG < 1
- •6. Patient with adequate organ function:
- •Absolute neutrophil count (ANC) = 1.5 x 109/L
- •Haemoglobin = 10 g/dL
- •Platelets (PTL) = 75 x 109/L
- •AST/ALT = 3x 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 (= 3 x ULN in case of liver metastases)
- •Normal Creatinine or if abnormal creatinine, Creatinine clearance =
- •50 mL/min (Cockcroft and Gault formula)
- •Albumin > 1 x LLN
- •Proteinuria < 30 mg/dL (1+) on the dipstick; in case of proteinuria =
- •30 mg/dL, 24 hours proteinuria must be = 1.5g
- •7. Patient with life expectancy > 3 months
- •8. Men or women, age =18 years
- •9. Men and women of childbearing potential must 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. Female patient of childbearing potential
- •must have a negative pregnancy test at screening and baseline.
- •10. Patient should be able and willing to comply with study procedures
- •as per protocol.
- •11. Patient should be able to understand, sign, and date the written
- •voluntary informed consent form at screening visit prior to any protocolspecific
- •procedures. 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.
- •12. 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.
- •13. Patients affiliated to a social security regimen
- •14. Patient weight > 40 kg and BMI > 18 kg/m²
- •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 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
排除标准
- •1. Patient previously treated by tyrosine kinase inhibitors except
- •imatinib in case of inclusion criteria 2
- •2. Patient treated for a cancer other than GIST within 5 years before
- •enrolment, with the exception of basal cell carcinoma or cervical cancer
- •3. Patient with active central nervous system (CNS) metastasis or with
- •history of CNS metastasis
- •4. 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 judgment of the
- •investigator, or symptomatic hypertension.
- •5. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere
- •with the ability to comply with the study protocol, or current or past
- •psychiatric disease that might interfere with the ability to comply with
- •the study protocol or give informed consent
- •6. Patient with any condition that the physician judges as detrimental
- •to subjects participating in this study, including any clinically important
- •deviations from normal clinical laboratory values or concurrent medical
- •1. Treatment with any investigational agent within 4 weeks prior
- •2. Treatment by imatinib as neoadjuvant/adjuvant therapy within 4
- •weeks prior baseline
研究者
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