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2014年1月9日

概览

暂无简介。

注册库

who.int

开始日期

2014年1月9日

结束日期

待定

最后更新

10年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

AB Science

•First randomisation inclusion criteria:
•1\.Histologically or cytologically confirmed adenocarcinoma of the pancreas
•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 \> 5mm on Visual Analogic 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’:
•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

•First randomisation exclusion criteria:
•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)