Venous thromboembolism in patients with malignancies MedDRA version: 9.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis
Conditions
Interventions
Trade Name: Fragmin®
Product Name: Fragmin®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dalteparin Sodium
CAS Number: 904108-1
Concentration unit: IU/ml international unit(s)/mill
Sponsors
Eisai Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age range: subjects must be ? 18 years of age. 2. Male and female subjects will be eligible for enrollment. 3. Females should be either of non-childbearing potential as a result of surgery, radiational therapy, menopause (one year post onset), or of childbearing potential and willing to adhere to an acceptable method of contraception 4. Subjects must be newly diagnosed, symptomatic proximal deep-vein thrombosis of the lower extremity, pulmonary embolism, or both. 5. Subjects must have active malignancy defined as a diagnosis of cancer (excluding basal cell or squamous cell carcinoma of the skin) within six months before enrollment, having received any treatment for cancer within the previous six months, or having documented recurrent or metastatic cancer. 6. Prior to enrollment, subjects must not have received therapeutic doses of anticoagulant therapy (including LMWH) for > 48 hours (or > 4 doses within 48 hours). Subjects must not have received unfractionated heparin within 4 hours prior to enrollment. 7. ECOG performance status of 0, 1 or 2. 8. Subjects must have a life expectancy of > 6 months. 9. Subjects must have a platelet count of > 75,000 mm3. 10. The subject must not be on any oral anticoagulant therapy for concomitant diseases. 11. Subjects must have no active or serious bleeding episodes within two weeks prior to study entry. 12. Subjects must be able to comply with scheduled follow-ups. 13. Subjects must give written 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. Subjects who have a high risk of serious bleeding (e.g. recent neurosurgery, history of intracranial hemorrhage, acute gastroduodenal ulcer, etc.). 2. Subjects who are on hemodialysis. 3. Subjects who have a prior placement of a greenfield filter or other device to prevent embolization of DVTs. 4. Subjects with a known contraindication to the use of heparin (e.g. heparin-induced thrombocytopenia). 5. Subjects with a known hypersensitivity to heparin, dalteparin, other LMWHs or pork products. 6. Subjects who are currently participating in another clinical trial involving anticoagulation therapy (with the exception of aspirin), participating in a clinical trial involving anticoagulation therapy (with the exception of aspirin) in the 30 days prior to study entry, or who is actively using any investigational drugs/treatments 30 days prior to study entry involving anticoagulation therapy (with the exception of aspirin x 3). 7. Subject is pregnant or breast feeding. 8. Subjects with uncontrolled hypertension characterized by a sustained systolic pressure > 170 mmHg and/or diastolic pressure > 100 mmHg. 9. Subjects with a serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the subject?s ability to complete the study. 10. Any condition that makes the subject unsuitable in the opinion of the investigator. 11. Subjects with acute leukemia. 12. Subjects with a genetic predisposition to clotting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine the rate of major bleeing events in cancer patients receiving extended treatment with dalteparin ( more than 6 months and up to 12 months) for prevention of recurrent symptomatic venous thromboembolism (VTE).;Secondary Objective: Secondary objectives will be to determine (for all subjects and according to baseline renal function): 1) the rate of recurrent VTEs (proximal DVT and or PE) during treatment; 2) time to symptomatic recurrent VTE; 3) the rate of minor bleeding events; 4) time to first major bleeding event; 5) time to first bleeding event (any bleeding event); and 6) the safety and tolerability of extended treatment with dalteparin. Additional objectives will include an evaluation of the utility of measuring anti-Xa activity to manage dose adjustment in subjects who present with or develop severe renal impairment (creatinine clearance less than 30 ml/min);Primary end point(s): The Central Adjudication Committee assessments for VTEs will be used as the primary assesment in the efficacy analysis. The investigator?s assessments will also be collected and used as secondary assessments in the analyses. The proportion of subjects with symptomatic, new or recurrent, lower limb DVT, PE, or CVT occurring while the subject is on treatment with dalteparin will be summarised together with the two-sided 95% confidence interval. | — |
Countries
Austria, Netherlands, Spain
Outcome results
None listed