The Effect of tinzaparin on Biomarkers in FIGO Stage III-IV Ovarian Cancer Patients Undergoing Neoadjuvant Chemotherapy – A randomized pilot study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Oestergoetland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 Apr 2022 → ongoing

Decision date (initial)

2024-10-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Medical Research Council of Southeast Sweden · LEO Pharma AB · The Swedish Society of Gynecologic Oncology · ALF grants Region Östergötland

External identifiers

EU CT number

2024-515450-24-00

EudraCT number

2021-000135-31

ClinicalTrials.gov

NCT05284552

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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 NACT.

Secondary objectives 1

1. 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. Thromboembolic events will be registered.

Conditions and MedDRA coding

Epithelial ovarian cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

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

Exclusion criteria 9

1. Concomitant treatment with heparins, low molecular weight heparins, warfarin or non-vitamin K antagonist oral anticoagulants. Platelet inhibitors are allowed.
2. Treatment with heparins, low molecular weight heparins or non-vitamin K antagonist oral anticoagulants within the last year.
3. Known or suspected allergies against any product included in the study
4. Abdominal surgery or other major surgery within the last year
5. Thromboembolic disease within the last year
6. 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.
7. Severe coagulation disorder
8. Platelets <100 x10^9/L (analyzed no more than 14 days before start of treatment with investigational product)
9. E-GFR <30ml/min (analyzed no more than 14 days before start of treatment with investigational product)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Level of CA-125 measured before cycles one-four of chemotherapy and preoperatively before DPDS.

Secondary endpoints 4

1. 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.
2. CA-125 measured before cycles five-seven of chemotherapy and three weeks after the last cycle of chemotherapy
3. The compliance to tinzaparin injections and occurrence of adverse events related to tinzaparin will be evaluated.
4. Objectively confirmed VTE, i.e. pulmonary embolism, lower-limb deep vein thrombosis or upper extremity deep vein thrombosis. Death due to VTE.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Oestergoetland

Sponsor organisation

Region Oestergoetland

Address

Universitetssjukhuset I Linkoping

City

Linkoping

Postcode

581 85

Country

Sweden

Scientific contact point

Organisation

Region Oestergoetland

Contact name

Anna Karlsson

Public contact point

Organisation

Region Oestergoetland

Contact name

Anna Karlsson

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications