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Clinical Trials/EUCTR2005-005336-27-IT
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

Sponsor
GlaxoSmithKline Ltd

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