The INPACT study (Improving with Nadroparin the Prognosis in Advanced Cancer Treatment)A randomized, controlled trial to evaluate the effects of nadroparin on survival and disease progression in patients with advanced malignancies of the lung, pancreas, or prostate

GlaxoSmithKline Research & Development Limited0 个研究点目标入组 500 人开始时间: 2006年2月23日最近更新: 2014年10月7日

适应症

试验速览

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•A subject will be eligible for this study only if the following criteria apply:
•1.Patients with HRPC within 6 months of diagnosis, locally advanced pancreatic cancer within 2 months of diagnosis or NSCLC (without pleural effusion) within 2 months of diagnosis of stage IIIB.
•2.Men and women aged =18 years.
•3.Informed consent.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Life expectancy of less than 3 months;
•2.Karnofsky preformance status <60;
•3.Indication for anticoagulant treatment;
•4.Any contraindication listed in the local labeling of nadroparin;
•5.Documented history of heparin-induced thrombocytopenia with UFH or LMWH;
•6.Severe thrombocytopenia (<50,000 / mm3);
•7.Current active bleeding or judged to be as high risk of bleeding;
•8.Documented brain metastasis;
•9.Creatinine Clearance <30 mL/min;
•10.Pregnancy;
•11.Women of child-bearing potential not using effective means of contraception;
•12.The subject will participate simultaneously in another clinical trial using investigational product.
•13.In France, a subject is neither affiliated with nor a beneficiary of a social security category.

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