EUCTR2005-005336-27-ITActive, not recruitingNot Applicable
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
GlaxoSmithKline Ltd0 sites500 target enrollmentStarted: August 30, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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