Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer

NCT05284552 | Recruiting Phase 2 DMC

• 2 other identifiers: The TABANETOC-trial2021-000135-31
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Epithelial Ovarian Cancer

Keywords

Tinzaparin; Neoadjuvant chemotherapy; FIGO stage III-IV

Outcome Measures

Primary Outcomes (1)

• Changes in serum levels of CA-125

  kIU/L

  14 weeks

Secondary Outcomes (13)

• Changes in serum levels of CA-125

  21-28 weeks

• Changes in blood levels of hemoglobin

  21-28 weeks

• Changes in blood levels of platelets

  21-28 weeks

• Changes in blood levels of leucocytes

  21-28 weeks

• Changes in plasma levels of CRP

  21-28 weeks

Other Outcomes (8)

• Plasma levels of tissue factor

  21-28 weeks

• Plasma levels of D-dimer

  21-28 weeks

• Plasma levels of soluble P-selectin

  21-28 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Drug: Tinzaparin (Innohep®), solution for injection. Administration form: Subcutaneous injection. Dosage: 4500 IU (for subjects weighing below 90 kg) or 8000 IU (for subjects weighing 90 kg and above) daily for 21-28 weeks.

Drug: Tinzaparin Injectable Solution

Control Arm

NO INTERVENTION

Interventions

Tinzaparin Injectable Solution DRUG

Subcutaneous injection

Also known as: Innohep®

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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, endometrioid carcinoma or clear cell carcinoma.
• FIGO stage III-IV disease.
• Selected for NACT with platinum double regimen at a multidisciplinary conference at Department of Oncology at Linköping University Hospital
• Receive treatment at either of the University Hospital in Linköping, or the hospitals in Jönköping (Ryhov Hospital), Eksjö (Highland Hospital, Eksjö), Västervik (Västervik hospital), Kalmar (County Hospital, Kalmar), Värnamo (Värnamo hospital).
• Planned for platinum doublet regimen.
• Prior to start of NACT pregnancy should be ruled out by menstrual history or in unclear cases by a urine human chorionic gonadotropin (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).
• World Health Organization (WHO) Performance Status 0-1
• Weight 50-150 kg
• CA-125-level ≥250 kIU/L at diagnosis

You may not qualify if:

• Concomitant treatment with heparins, low molecular weight heparins, warfarin or nonvitamin 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),

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Region Jönköping County: collaborator
• Västervik Hospital: collaborator
• Vastra Gotaland Region: collaborator
• Region Västerbotten: collaborator

Study Sites (8)

Department of Obstetrics and Gynecology, Highland Hospital

Eksjö, 575 81, Sweden

RECRUITING

Department of Oncology, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

Department of Obstetrics and Gynecology, Ryhov County Hospital

Jönköping, 55305, Sweden

RECRUITING

Department of Oncology, Linköping University Hospital

Linköping, 58185, Sweden

RECRUITING

Department of Obstetrics and Gynaecology, Norrland University Hospital

Umeå, 90719, Sweden

RECRUITING

Department of Obstetrics and Gynecology, Värnamo Hospital

Värnamo, 33152, Sweden

RECRUITING

Department of Obstetrics and Gynecology, Västervik Hospital

Västervik, 593 81, Sweden

RECRUITING

Department of Obstetrics and Gynecology, University Hospital

Linköping, Östergötland County, 58185, Sweden

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Preben Kjölhede, MD, PhD

  University Hospital, Linkoeping

  STUDY CHAIR

• Gabriel Lindahl, MD, PhD

  University Hospital, Linkoeping

  STUDY CHAIR

• Anna-Clara Spetz Holm, MD, PhD

  University Hospital, Linkoeping

  STUDY CHAIR

• Anna Karlsson, MD

  University Hospital, Linkoeping

  STUDY CHAIR

Central Study Contacts

Preben Kjölhede, MD, PhD

CONTACT

+46101030000; preben.kjolhede@regionostergotland.se

Anna Karlsson, MD

CONTACT

+46101030000; anna.br.karlsson@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, senior consultant

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: March 17, 2022
• Study Start: July 12, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (8)