Thromboprophylaxis in patients with advanced pancreatic cancer MedDRA version: 20.0 Level: PT Classification code 10043607 Term: Thrombosis System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1 Level: PT Classification code 10068067 Term: Tumour thrombosis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: innohep® 20.000 Anti-Xa IU/ml
Product Name: Innohep
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
INN or Proposed INN: tinzaparin sodium
CAS Number: 9041-08-1
Sponsors
Institute of Molecular Medicine and Biomedical Research (IMBE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Locally Advanced or metastatic PC (confirmed by the recommended histological and imaging methods). 2.Age = 18 years. 3.Planning to start 1st line chemotherapy with NabG. 4.Eastern Cooperative Group (ECOG) 0-2. 5.Life expectancy >6 months. 6.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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1.Subjects with contraindication to receive anticoagulant: a. Any hypersensitivity to anticoagulant or excipients. b. History of heparin-induced thrombocytopenia type II (HIT II). c. Active major bleeding or pre-diathesis for major bleeding d. Septic endocarditis. 2.Creatinine clearance 5 x ULN, bilirubin > 2 x ULN. 5.Recent (< 1 month) oncological surgery, major abdominal or thoracic surgery, major orthopedic surgery, vascular surgery. 6.Recent (< 1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or hemorrhagic stroke. 7.Patients on chronic anticoagulation or on dual anti-platelet treatment. 8.Pregnancy/lactation or insufficient contraception during the study and up to 3 months after the study. 9.Severe concomitant disease that as per investigator’s judgement is not compatible with participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives •Evaluate the impact of VTE prevention on progression-free survival (PFS). •Investigate the efficacy of long term VTE prevention with simultaneously administration of tinzaparin during 1st line chemotherapy in patients undergoing anticancer treatment with NabG for locally advanced or metastatic PC. ;Secondary Objective: Secondary Objective •Determine the safety and tolerability of tinzaparin in combination with NabG for locally advanced or metastatic PC during the study. •Determine overall response rates (ORR) according to Response Evaluation Criteria (Response Evaluation Criteria in Solid Tumors (RECIST) in advanced PC subjects during the study. •Evaluation of the effect of VTE prevention on overall survival (OS) of patients with advanced PC during the study •Determine quality of life (QoL).;Primary end point(s): •PFS of patients receiving thromboprophylaxis with tinzaparin, in comparison with the PFS of patients not receiving such prevention (primary endpoint). •All objectively confirmed VTE events during the study per treatment arm including symptomatic distal deep vein thrombosis (DVT), symptomatic or incidental proximal DVT (including iliac and cava thrombosis), symptomatic or incidental pulmonary embolism (PE) or both DVT and PE (co-primary endpoint) or fatal PE or vein thrombosis of rare localisation (i.e., splanchnic vein or cerebral vein thrombosis). ;Timepoint(s) of evaluation of this end point: PFS will be calculated from entry date onto thromboprophylaxis until date of objective disease progression or death from any cause using the RECIST criteria. The VTE events will be evaluated during the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •% of patients experiencing at least one major bleeding event, according to the International Society on Thrombosis and Haemostasis (ISTH) criteria during the study per treatment arm. •% of patients experiencing any bleeding event, including major, clinically relevant non-major bleeding (CRNMB) and minor bleeding events during the study per treatment arm. •Incidence of VTE events, per event type, during the study per treatment arm. •ORR, defined as the percentage of patients with complete response (CR) or partial response (PR) based on RECIST criteria. •Overall Survival (OS) of patients receiving tinzaparin thromboprophylaxis compared to OS of patients not receiving such prophylaxis. •Change from baseline in QoL at 4 months and 10 months per treatment arm. QoL will be determined with the EORTC QLQ-C30 version 3.0. and EORTC QOL-PAN26 questionnaires according to the corresponding scoring manual. ;Timepoint(s) of evaluation of this end point: The VTE events, bleedings and other outcomes will be evaluated during the study. The changes in QoL will be evaluated at 6 months and 10 months after treatment initiation. | — |
Countries
Greece
Contacts
Public ContactCommunication IMBE
Institute of Molecular Medicine and Biomedical Research (IMBE)
Outcome results
None listed