TINZAPARIN SODIUM for Epithelial ovarian cancer | Fallopian tube cancer | Primary peritoneal carcinoma

Inclusion criteria

• {"criterion_text":"- Epithelial ovarian, fallopian tube or peritoneal cancer, or abdominal cancer where a biopsy indicates an origin from the ovary, fallopian tube or peritoneum."}
• {"criterion_text":"- Histology diagnosis of either high grade serous carcinoma, endometroid carcinoma or clear cell carcinoma."}
• {"criterion_text":"- FIGO stage III-IV disease."}
• {"criterion_text":"- Planned for platinum-based chemotherapy"}
• {"criterion_text":"- WHO Performance Status 0-2"}
• {"criterion_text":"- CA-125-level ≥250 kIE/L at diagnosis"}
• {"criterion_text":"- Weight 50-150 kg"}
• {"criterion_text":"- Age 18 and above"}

Exclusion criteria

• {"criterion_text":"- Concomitant treatment with heparins, low molecular weight heparins, warfarin or non-vitamin K antagonist oral anticoagulants. Platelet inhibitors are allowed."}
• {"criterion_text":"- Treatment with heparins, low molecular weight heparins or non-vitamin K antagonist oral anticoagulants within the last year."}
• {"criterion_text":"- Known or suspected allergies against any product included in the study"}
• {"criterion_text":"- Abdominal surgery or other major surgery within the last year"}
• {"criterion_text":"- Thromboembolic disease within the last year"}
• {"criterion_text":"- Serious hemorrhage or conditions predisposing to serious hemorrhage. Serious hemorrhage is defined as fulfilling any one of these three criteria: a) occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome), b) causes a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or c) leads to transfusion of two or more units of whole blood or red blood cells."}
• {"criterion_text":"- Severe coagulation disorder"}
• {"criterion_text":"- Platelets <100 x10^9/L (analyzed no more than 14 days before start of treatment with investigational product)"}
• {"criterion_text":"- E-GFR <30ml/min (analyzed no more than 14 days before start of treatment with investigational product)"}

Primary endpoints

• {"endpoint_text":"- Level of CA-125 measured before cycles one-four of chemotherapy and preoperatively before DPDS.","definition_or_measurement_approach":"Level of CA-125 measured before cycles one-four of chemotherapy and preoperatively before DPDS."}

Secondary endpoints

• {"endpoint_text":"- Levels of hemoglobin, platelets, leucocytes, CRP, albumin, IL-6 and VEGF before every cycle of chemotherapy, preoperatively before DPDS and three weeks after the last cycle of chemotherapy.","definition_or_measurement_approach":"Serial laboratory measurements of hemoglobin, platelets, leucocytes, CRP, albumin, IL-6 and VEGF before every chemotherapy cycle, preoperative sampling before DPDS and at three weeks after the last chemotherapy cycle."}
• {"endpoint_text":"- CA-125 measured before cycles five-seven of chemotherapy and three weeks after the last cycle of chemotherapy","definition_or_measurement_approach":"CA-125 measurements before cycles five-seven and at three weeks after the last chemotherapy cycle."}
• {"endpoint_text":"- The compliance to tinzaparin injections and occurrence of adverse events related to tinzaparin will be evaluated.","definition_or_measurement_approach":"Assessment of injection compliance (reported/recorded) and recording of adverse events attributed to tinzaparin."}
• {"endpoint_text":"- Objectively confirmed VTE, i.e. pulmonary embolism, lower-limb deep vein thrombosis or upper extremity deep vein thrombosis. Death due to VTE.","definition_or_measurement_approach":"Recording of objectively confirmed venous thromboembolism events (diagnosed via standard clinical imaging/diagnostic criteria) and VTE-related deaths."}

Sweden

Earliest CTIS Part Ii Submission Date

12-06-2024

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

614

Number Of Sites

8

Number Of Participants

40

Primary sponsor

Full Name

Region Oestergoetland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"","full_name":"Medical Research Council of Southeast Sweden","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"LEO Pharma AB","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"The Swedish Society of Gynecologic Oncology","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"ALF grants Region Östergötland","duties_or_roles":"Source of monetary support","organisation_type":""}