EUCTR2009-017918-69-AT进行中（未招募）1 期
A prospective, multicenter, randomized, open-label, active-controlled, two-parallel groups, phase 3 study to compare the efficacy and safety of masitinib at 7.5 mg/kg/day to dacarbazine in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-kit - Not applicable
AB Science0 个研究点目标入组 78 人开始时间: 2010年11月16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
- 78
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. Patient >18 years old, male or female, weighting more than 40 kg and with a Body Mass Index
- •(BMI)>18 kg/m²
- •2. Patient with histologically or cytologically confirmed non-resectable or metastatic stage 3 (non-resectable
- •IIIB or IIIC, AJCC TNM staging system 7th edition) or stage 4 melanoma
- •3. Patient with detectable c-kit JM mutation(mutation in exon 9, 11 or 13)confirmed by DNA or RNA
- •sequencing, which is expected to be mainly found after screening of mucosal or acral melanoma or melanoma
- •on skin with chronic sun-induced damages (defined by a microscopically marked elastosis involving the skin
- •surrounding their primary melanoma)
- •4. Patient with measurable disease according to RECIST
- •5. Patient with ECOG = 2
- •6. Patient with life expectancy > 3 months
- •7. 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/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 = 1.5 x ULN (= 3 x ULN in case of liver metastases)
- •· Normal Creatinine or if abnormal creatinine, creatinine clearance = 50 mL/min (Cockcroft and Gault
- •· Albuminaemia =1 x LLN
- •Study Protocol - AB08026 - Version 6.0/AT02 dated 09 January 2015 Page 4 of 121
- •Confidential
- •· Proteinuria < 30 mg/dL on dipstick; in case of proteinuria = 30 mg/dL, 24-hour proteinuria = 1.5 g/24 h
- •8. Female patient of childbearing potential (entering the study after a menstrual period and who have a negative
- •pregnancy test), who agrees to use two highly effective 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. Acceptable forms of contraception include:
- •o 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] used with
- •spermicidal foam/gel/film/cream/suppository)
- •o Documented tubal ligation (female sterilization). In addition, a barrier method used with spermicidal foam/gel/film/cream/suppository) should also be used
- •o Double barrier method with
- •spermicidal foam/gel/film/cream/suppository
- •o Any other contraceptive method with a documented failure rate of <1% per year
- •o Abstinence
- •Male patients must use medically acceptable methods of contraception if his female partner is pregnant, from the
- •time of the first administration of the study drug until three months following administration of the last dose of
- •study drug. Acceptable methods include:
- •o If you have undergone surgical sterilization (vasectomy with documentation of azoospermia) a
- •condom should also be used.
- •Male patients must use two highly effective 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. The acceptable
- •methods of contraception are as follows:
- •o Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal
- •foam/gel/film/cream/suppository;
- •o Surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method
- •(condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal
- •foam/gel/film/cream/suppository);
- •o Your female partner uses oral contraceptives (combination oestrogen/progesterone pills), injectable
- •progesterone or subdermal implants and
排除标准
- •1.Pregnant, or nursing female patient
- •2. Patient with other malignancies from which the patient has been continuously disease-free for < 3 years, with
- •the exception of melanoma, cervical carcinoma in situ, basal cell or squamous cell skin cancer, ductal or
- •lobular carcinoma in situ of the breast
- •3. Patient with active brain metastases are not eligible. Patients with treated brain metastases are eligible if :
- •(a) presence of 3 brain lesions or less
- •(b) lesion(s) diameter is = 2 cm
- •(c) radiation therapy (gamma knife) was completed = 4 weeks prior to baseline
- •(d) surgery was completed =4 weeks prior to baseline
- •(e) lesions assessed by follow-up scan (or MRI if MRI performed before brain therapy) = 1 month after brain
- •therapy are considered under control at baseline
- •4. Patient refractory to dacarbazine defined as patient presenting with disease progression within 3 months from
- •the start of a previous dacarbazine therapy.
- •5. Prior treatment with a tyrosine kinase c-kit inhibitor
- •6. Patient 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
- •7. Patient with clinically uncontrolled infectious diseases including HIV or AIDS-related illness
- •8. Major surgery or radiation therapy within four weeks of starting the study treatment
- •9. Patient with an history of poor compliance or an 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
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