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 - INPACT

• Conditions: patients with advanced malignancies of the lung, pancreas, or prostate.; MedDRA version: 6.1Level: HLTClassification code 10029111

• Registration Number: EUCTR2005-005336-27-IT
• Lead Sponsor: GlaxoSmithKline Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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 8805;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

Exclusion Criteria

Life expectancy of less than 3 months; 5. Karnofsky performance status 60; 6. Indication for anticoagulant treatment; 7. Any contraindication listed in the local labeling of nadroparin; GM2005/00459/00 CONFIDENTIAL FRX106365 18 8. Documented history of heparin-induced thrombocytopenia with UFH or LMWH; 9. Severe thrombocytopenia 50,000 / mm3 ; 10. Current active bleeding or judged to be as high risk of bleeding; 11. Documented brain metastasis; 12. Creatinine Clearance 30 mL/min; 13. Pregnancy; 14. Women of child-bearing potential not using effective means of contraception; 15. The subject will participate simultaneously in another clinical trial using investigational product; 16. In France, a subject is neither affiliated with nor a beneficiary of a social security category.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified