A clinical study for the long-term protection of prostate and breast cancer patients from thrombosis

Phase 1

• Conditions: ong-term thromboprophylaxis with tinzaparin in high-risk prostate or breast cancer patients.; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 20.0Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865

• Registration Number: EUCTR2018-001230-18-GR
• Lead Sponsor: Hellenic Genito-Urinary Cancer Group (HGUCG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1052

Inclusion Criteria

•Histologically confirmed breast or prostate cancer, including previously untreated patients and patients with recurrent disease after previous local and/or systemic therapy
•Age =18 years
•Planned endocrine therapy, chemotherapy, or targeted anticancer therapy within 1 month from study enrolment; patients may also have started such therapy less than 1 month before study enrolment
•High risk for VTE according to the COMPASS-CAT RAM (score =7)
•ECOG 0-2
•Life expectancy >6 months
•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 632
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 420

Exclusion Criteria

•Hypersensitivity to heparin
•History of heparin-induced thrombocytopenia
•Ongoing anticoagulant treatment (patients receiving antiplatelet agents are not excluded)
•Objectively confirmed VTE at inclusion before treatment group assignment or incidental VTE found when imaging methods for disease staging are performed
•Creatinine clearance <20 mL/min according to Cockcroft-Gault formula
•Active bleeding
•Platelet count <50 G/L at inclusion
•Hepatic dysfunction defined as at least 1 of the following: Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5 × ULN, bilirubin >2 × ULN
•Cancer treated exclusively with supportive care
•Patient enrolled in another trial at the time of screening
•Recent (<1 month) oncological surgery, major abdominal or thoracic surgery, major orthopaedic surgery, vascular surgery
•Recent (<1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or haemorrhagic stroke
•Pregnancy

Study & Design

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