A prospective, multicenter, double-randomised, double-blind, 2-parallel groups, phase 3 study to compare as first line therapy efficacy and safety of masitinib in combination with gemcitabine, to gemcitabine in combination with placebo, followed as second line treatment by masitinib in combination with Folfiri.3 versus placebo in combination with Folfiri.3 in the treatment of patients with non resectable locally advanced or metastatic pancreatic cancer.

AB Science0 个研究点目标入组 549 人开始时间: 2014年2月18日最近更新: 2019年6月30日

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: 549

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•1.Histologically or cytologically confirmed adenocarcinoma of the pancreas, non resectable locally advanced or metastatic stage, non resectable locally advanced or metastatic stage
•2.Patient with pain related to the disease, as assessed by the investigator and the patient:
•-Pain related to the disease as assessed by the investigator is defined as clinical and documented evaluation by the investigator during physical examinations at screening and/or baseline.
•-Pain, as assessed by the patient is defined as at least one value out of two values > 20mm on Visual Analogue Scale at screening or baseline. Visual Analogic scale consists in the visual representation of pain amplitude as perceived by the patient. The amplitude is represented by a 100 mm long line having no reference marks. One extremity indicates an absence of pain (0 value) and the other the worst imaginable pain (100 value).
•Patient treated with opioid analgesics at a dose = 1 mg/kg/day (morphinic equivalent).
•Patients with ‘genetic fingerprint of aggressiveness ACOX1 (DCt = 3.05)’
•3.Chemotherapy naïve patient for the advanced/metastatic disease
•4.Documented decision justifying non eligibility for surgical resection.
•5.Patient with measurable tumor lesions with longest diameter = 20 mm using conventional techniques or = 10 mm with spiral CT scan according to RECIST 1.1
•6.Patient with ECOG = 2
•7.Patient with adequate organ functions:
•Absolute neutrophils count (ANC) = 1.5 x 109/L
•Haemoglobin = 10 g/dL
•Platelets (PTL) = 75 x 109/L
•AST/ALT = 5 x ULN
•Gamma GT = 5 x ULN
•Bilirubin = 3 x ULN
•Normal Creatinine or if abnormal creatinine, creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
•Albumin > 1x 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
•8.Patient with life expectancy > 3 months
•9.Male or female patient, age ?18 years
•10.Patient with a BMI > 18 kg/m² and >40 kg
•11.Female patient of childbearing potential. 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] used with spermicidal foam/gel/film/cream/suppository)
•Documented tubal ligation (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
•12.Male patients must use medically acceptable methods of contraception if your 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 s

排除标准

•1.Patient treated for a cancer other than pancreatic cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
•2.Patient with no pain related to the disease (as defined in the inclusion criterion number 2) and no genetic fingerprint of aggressiveness
•3.Patient with ECOG = 3
•4.Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
•5.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
•6.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
•7.Pregnant, intent to be pregnant, or nursing female patient
•8.Patient eligible to Folfirinox treatment
•SAFETY RULES FOR SECOND RANDOMISATION
•If patients discontinued for safety reasons related to study treatment or reasons not assessable, the patients cannot be re-randomized.
•If patient’s dose of study treatment was reduced for safety reasons and patient had progressed at the dose reduced, the patients will be re-randomized at the last reduced dose tolerated.
•The second randomisation will only be made at the last dose of masitinib or placebo treatment received during the first randomisation. This is the dose that the patient tolerated in the first randomisation phase.
•If patients are ongoing with a grade 2 or grade 3 AE and progressed, patients cannot be re-randomized while having AE.
•The outcome of grade 2 or grade 3 AE might be:
•- Discontinuation. In this case patients will not be re-randomized (see before).
•- Dose reduction and the reduced dose is tolerated. In this case patients will be re-randomized in case of progression at this reduced tolerated dose (see before).
•- Return to baseline or grade 1 with no dose reduction and the reduced dose is tolerated. In this case patients will be re-randomized at this tolerated dose in case of progression.
•Patient having presented with disabling or life-threatening adverse event due to first line treatment will be excluded.
•Those patients who according to the assessment of the PI would benefit more from an alternative therapy will continue to be excluded from the second randomi

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发起方

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