CTRI/2014/10/005095进行中（未招募）3 期
A prospective multicenter randomized open-label active controlled two-parallel groups phase3 study to compare the efficacy and safety of masitinib at7.5mg/kg/day to dacarbazine in the treatment of patients with non-resectable or metastatic stage3 or stage4 melanoma carrying a mutation in the juxta membrane domain of c-kit
AB Science0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 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
入排标准
入选标准
- •1. Patient >18 years old, male or female, weighting more than 40 kg or 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)
- •- Creatine clearance >= 50 mL/min (Cockcroft and Gault formula)
- •- Albuminaemia >= 1 x LLN
- •- Urea <= 2x ULN
- •- 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. Man or woman of child bearing 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 three months after the last treatment intake. Female patients of childbearing potential must have a negative result in the pregnancy test at screening and baseline.
- •9. Patient able and willing to comply with study visits and procedures as per protocol
- •10. 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.
- •11. 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. 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 (atrioventricular
- •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 consent
- •10. Previous radiotherapy, chemotherapy and/or previous adjuvant therapy with interferon, vaccines or therapy
- •with IL-2 or GM-CSF within 4 weeks prior to baseline. Those patients will require a four weeks wash-out
- •period before baseline. Similarly, any previous treatment with an investigational agent will Require a washout period of four weeks before baseline
研究者
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