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 sites500 target enrollmentStarted: January 18, 2007Last updated: March 19, 2012

Conditions

Trial Snapshot

No summary available.

•A subject will be eligible for this study only if the following criteria apply:
•1.Patients with HRPC within 6 months of diagnosis of hormone-refractory status, locally advanced pancreatic cancer or NSCLC (without clinically significant pleural effusion on chest X-ray) within 3 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 participated in another clinical trial using an investigational product within one month before randomization.
•13.In France, a subject is neither affiliated with nor a beneficiary of a social security category.

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