Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer

Recruiting now · Phase 2

Conditions studied: Epithelial Ovarian Cancer

In brief

Background: Previous findings have indicated antineoplastic properties of tinzaparin (Innohep®), a commonly used anti-coagulant. Earlier studies have mainly investigated the antineoplastic effects of tinzaparin in animal models and in human cell-lines. In this pilot study the aim is to examine the potential antitumoral effects of tinzaparin in vivo in women with epithelial ovarian cancer (EOC). Study objectives: Primary objective: The primary objective of the study is to evaluate the effects of tinzaparin on changes in levels of CA-125 in EOC patients who receive neoadjuvant chemotherapy (NACT). Secondary objectives: The secondary objective of the study is to explore the impact of tinzaparin on the dynamic of a spectrum of immunological and coagulation factors in EOC patients who receive NACT. Besides, the compliance of tinzaparin injections and adverse events caused by tinzaparin will be described.

Key facts

Study ID

NCT05284552

Run by

University Hospital, Linkoeping

People needed

40

Starts

2022-07-12

Expected to finish

2027-12-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• The subject has given written consent to participate in the study.
• Age 18 and above
• Epithelial ovarian, fallopian tube or peritoneal cancer, or abdominal cancer where a biopsy indicates an origin from the ovary, fallopian tube or peritoneum.
• Histology diagnosis of either high grade serous carcinoma, endometroid carcinoma or clear cell carcinoma.
• FIGO stage III-IV disease.
• Planned for platinum-based chemotherapy
• Prior to start of NACT pregnancy should be ruled out by menstrual history or in unclear cases by a urine hCG test.
• Women of childbearing potential should use a safe birth control method (combined hormonal contraception, progesterone only hormonal contraception, intra uterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence, male or female condom, diaphragm with spermicide).
• WHO Performance Status 0-2
• Weight 50-150 kg
• CA-125-level ≥250 kIE/L at diagnosis

You may not qualify if…

• Concomitant treatment with heparins, low molecular weight heparins, warfarin or non-vitamin K antagonist oral anticoagulants. Platelet inhibitors are allowed.
• Treatment with heparins, low molecular weight heparins or non-vitamin K antagonist oral anticoagulants within the last year.
• Known or suspected allergies against any product included in the study
• Ongoing pregnancy, independent of gestational age. Breastfeeding or planned pregnancy
• EOC disclosed at Cesarean section
• Abdominal surgery or other major surgery within the last year
• Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
• Treatment or disease which, according to the investigator, can affect treatment or study results
• Known brain metastasis
• Participation or recent participation (within the last 30 days) in a clinical study with an investigational product
• Ongoing treatment of thromboembolic disease.
• Thromboembolic disease within the last year.
• Hypersensitivity to the active substance (tinzaparin) or any of the excipients.
• Serious hemorrhage or conditions predisposing to serious hemorrhage. Serious hemorrhage is defined as fulfilling any one of these three criteria:
• occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome),
• causes a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or
• leads to transfusion of two or more units of whole blood or red blood cells.
• Severe coagulation disorder.
• Acute gastro duodenal ulcer.
• Septic endocarditis.
• Previous heparin-induced thrombocytopenia.
• WHO Performance Status >2.
• E-GFR <30ml/min (analyzed no more than 14 days before start of treatment with investigational product)
• Platelets <100 x10\^9/L (analyzed no more than 14 days before start of treatment with investigational product)
• Treatment for other known malignancy within the last year (except basal cell carcinoma)

Where it is running

• Department of Obstetrics and Gynecology, Highland Hospital — Eksjö, Eksjö, Sweden (enrolling)
• Department of Oncology, Sahlgrenska University Hospital — Gothenburg, Gothenburg, Sweden (enrolling)
• Department of Obstetrics and Gynecology, Ryhov County Hospital — Jönköping, Jönköping County, Sweden (enrolling)
• Department of Oncology, Linköping University Hospital — Linköping, Linköping, Sweden (enrolling)
• Department of Obstetrics and Gynaecology, Norrland University Hospital — Umeå, Umeå, Sweden (enrolling)
• Department of Obstetrics and Gynecology, Värnamo Hospital — Värnamo, Värnamo, Sweden (enrolling)
• Department of Obstetrics and Gynecology, Västervik Hospital — Västervik, Västervik, Sweden (enrolling)
• Department of Obstetrics and Gynecology, University Hospital — Linköping, Östergötland County, Sweden

Full record on ClinicalTrials.gov

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