TINZAPARIN SODIUM for Advanced pancreatic cancer

Inclusion criteria

• {"criterion_text":"- Locally Advanced or metastatic PC (confirmed by the recommended histological and imaging methods).\n- Age ≥ 18 years.\n- Planning to start 1st line chemotherapy with NabG.\n- Eastern Cooperative Group (ECOG) 0-2.\n- Life expectancy >6 months.\n- Written informed consent."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Creatinine clearance <20 mL/min according to Cockcroft-Gault formula.\n- Platelet count < 50 G/L at inclusion.\n- Hepatic dysfunction defined as at least one of the following: AST and/or ALT > 5 x ULN, bilirubin > 2 x ULN.\n- Recent (< 1 month) oncological surgery, major abdominal or thoracic surgery, major orthopedic surgery, vascular surgery.\n- Recent (< 1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or hemorrhagic stroke.\n- Patients on chronic anticoagulation or on dual anti-platelet treatment.\n- Pregnancy/lactation or insufficient contraception during the study and up to 3 months after the study.\n- Severe concomitant disease that as per investigator's judgement is not compatible with participation in the study."}

Primary endpoints

• {"endpoint_text":"- PFS of patients receiving thromboprophylaxis with tinzaparin, in comparison with the PFS of patients not receiving such prevention (primary endpoint).","definition_or_measurement_approach":"Progression-Free Survival (PFS) as stated for patients receiving tinzaparin versus those not receiving thromboprophylaxis; specific measurement methodology not detailed in the provided record."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"All objectively confirmed VTE events captured during the study per treatment arm; event types listed (symptomatic distal DVT, symptomatic/incidental proximal DVT including iliac and cava thrombosis, symptomatic/incidental PE, combined DVT and PE, fatal PE, splanchnic or cerebral vein thrombosis)."}

Secondary endpoints

• {"endpoint_text":"- % 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.","definition_or_measurement_approach":"Proportion of patients with ≥1 major bleeding event assessed per ISTH criteria, by treatment arm."}
• {"endpoint_text":"- % of patients experiencing any bleeding event, including major, clinically relevant non-major bleeding (CRNMB) and minor bleeding events during the study per treatment arm.","definition_or_measurement_approach":"Proportion of patients experiencing any bleeding event (major, CRNMB, minor) during study, by treatment arm."}
• {"endpoint_text":"- Incidence of VTE events, per event type, during the study per treatment arm.","definition_or_measurement_approach":"Incidence rates of VTE events broken down by event type (as listed in primary endpoints), per treatment arm."}
• {"endpoint_text":"- ORR, defined as the percentage of patients with complete response (CR) or partial response (PR) based on RECIST criteria.","definition_or_measurement_approach":"Overall response rate (ORR) measured as % of patients with CR or PR according to RECIST criteria."}
• {"endpoint_text":"- Change from baseline in QoL at 4 months and 10 months per treatment arm.","definition_or_measurement_approach":"Change from baseline in quality of life (QoL) measured at months 4 and 10 per treatment arm; specific QoL instrument not specified here (patient-facing QLQ-C30 Greek document present in documents)."}
• {"endpoint_text":"- Overall Survival (OS) of patients receiving tinzaparin thromboprophylaxis compared to OS of patients not receiving such prophylaxis.","definition_or_measurement_approach":"Overall survival comparison between tinzaparin thromboprophylaxis recipients and non-recipients; specific censoring rules not provided in the record."}

Greece

Earliest CTIS Part Ii Submission Date

13-01-2025

Latest Decision Or Authorization Date

23-01-2025

Processing Time Days

10

Number Of Sites

7

Number Of Participants

450

Primary sponsor

Full Name

Institute Of Molecular Medicine And Biomedical Research

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Greece

Third parties

• {"country":"Greece","full_name":"Phaze S.A.","duties_or_roles":"Sponsor duties codes: 1,10,11,12,13,14,3,5,6,7,8 (as listed in CTIS third party record)","organisation_type":"Pharmaceutical company"}