Advanced malignancies of the lung, pancreas, or prostate.
Conditions
Interventions
Trade Name: Fraxiparin
Product Name: Nadroparin calcium, 9,500 IU/ml, injection (Fraxiparin 0.4, PL.-Nr. 40533.02.00)
Pharmaceutical Form: Injection*
INN or Proposed INN: nadroparin calcium
Concentrat
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 3 months of diagnosis or NSCLC (without pleural effusion) 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
Exclusion criteria
Exclusion criteria: 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 participaticpated in another clinical trial using an investigational product within one month prior before Randomization. 13. In France, a subject is neither affiliated with nor a beneficiary of a social security category. [In Germany, female patients who are breastfeeding or patients confined by order of either judicial or administrative authorities]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective is to evaluate the effects of an intermittent schedule of nadroparin on death due to all causes in patients with advanced malignancies of the lung, pancreas, or prostate. The principal safety outcome is major bleeding.;Secondary Objective: The secondary efficacy objective is to determine the effects of an intermittent schedule of nadroparin on time to progression. The additional safety outcome is clinically relevant bleeding (i.e. major bleeding and other clinically relevant non-major bleeding).;Primary end point(s): Efficacy The primary efficacy outcome is death due to all causes. Safety The principal safety outcome is major bleeding. | — |
Countries
Czech Republic, Germany, Hungary, Italy, Slovenia
Outcome results
None listed