Prophylaxis of venous thromboembolic disease with LMWH (TINzaparin) in patients with metastatic colorectal cancer who start the first line of treatment.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Grupo Gallego De Investigacion En Tumores Digestivos

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Cardiovascular Diseases [C14], Not possible to specify

Trial duration

28 Feb 2023 → 4 Jun 2025

Decision date (initial)

2024-05-22

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-508860-31-00

EudraCT number

2022-001534-11

ClinicalTrials.gov

NCT05625932

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

The main objective of the study is to evaluate the efficacy of 4-months prophylaxis with LMWH (tinzaparin) for the prevention of symptomatic or incidental VTE events in patients with stage IV colorectal cancer (mCRC) that initiate first line systemic treatment (ChT +/- targeted therapy).

Conditions and MedDRA coding

Stage IV colon or rectal adenocarcinoma (mCRC).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Male or female subjects with age ≥ 18 years. 2. Written informed consent. 3. Patients with a histologically confirmed diagnosis of stage IV colon or rectal adenocarcinoma (mCRC). 4. Locally assessed BRAF and RAS genomic alterations available during screening. 5. Beginning of the first line of treatment for metastatic disease with chemotherapy +/- targeted therapy (i.e. antiangiogenic, anti-EGFR, encorafenib-cetuximab doublet) or immunotherapy. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 7. Life expectancy >6 months.

Exclusion criteria 1

1. 1. Contraindication to tinzaparin, or other heparins: a. Allergy (or hypersensitivity) to heparin, tinzaparin, other LMWHs, or pork products. b. History or presence of heparin-induced (type II) thrombocytopenia. c. Have or have had an epidural catheter or a traumatic spinal puncture within the previous 7 days. 2. Prothrombin time (PT) (International normalized ratio [INR] >1.5 for any reason) or aPTT >2 times control value. 3. Active or recent (<3 months) major bleeding or conditions predisposing to major bleeding. A major bleeding is defined as one that meets one of the following three criteria: a. occurring in a critical area or organ (for example, intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular or pericardial, intrauterine or intramuscular with compartment syndrome), b. causing a decrease in hemoglobin levels of 2 g/l (1.24 mmol/l) or more, or c. that requires a transfusion of two or more units of whole blood or packed red blood cells. 4. Lesions or conditions at increased risk of clinically significant bleeding, including: a. Previously diagnosed/treated VTE ≤ 28 days prior to randomization. b. Active ulcer disease. c. Diagnosed cerebral metastases. d. Stroke within the prior 6 months. e. History of central nervous system (CNS) or intraocular bleeding. 5. Requirement of other anticoagulant therapy, dual antiplatelet therapy, daily non-steroidal anti-inflammatory drugs, or other medications known to increase the risk of bleeding. Note: A daily dose of ≤100 mg of aspirin and single agent clopidogrel are permitted 6. Acute or chronic renal insufficiency with Creatinine clearance < 30 ml / min. 7. Platelet count < 80.000 /μl at the time of inclusion. 8. Severe liver insufficiency as defined by clinical manifestations of ascites, cirrhosis, encephalopathy and/or jaundice and/or biochemical abnormalities in liver function tests including: a. elevated levels of total bilirubin (> 2 times the upper limit normal [ULN]), b. elevated liver transaminases ALT or AST (> 2 times the ULN; > 5 in case of hepatic metastasis). 9. Participating in another study of an investigational agent at the time of enrollment. Note: Use of an experimental regimen of an approved product is not cause for exclusion. 10. Patients who weigh < 50 Kg. 11. Women of childbearing potential (WOCBP), must provide a negative serum or urine pregnancy test at screening. Women breastfeeding are not eligible. Note: A pregnancy test is performed on WOCBP as per standard of care for patients undergoing anticancer treatments. 12. Any underlying medical or psychiatric disorder, which, in the opinion of the investigator, makes the administration of tinzaparin unsafe or interferes with the informed consent process or trial procedures.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary efficacy endpoint is the cumulative incidence of any VTE event including: ● Symptomatic non-fatal pulmonary thromboembolism (PE). ● Symptomatic lower-limb deep vein thromboembolism (sllDVT). ● Symptomatic upper extremity deep vein thromboembolism (sueDVT). ● Incidentally diagnosed PE or proximal DVT. ● Symptomatic central venous catheter thromboembolism. ● Incidentally visceral vein thrombosis (iVVT). ● Symptomatic visceral vein thrombosis (sVVT). ● VTE-related deaths

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Grupo Gallego De Investigacion En Tumores Digestivos

Sponsor organisation

Grupo Gallego De Investigacion En Tumores Digestivos

Address

Rua De Ramon Y Cajal Num. 2

City

Lugo

Postcode

27001

Country

Spain

Scientific contact point

Organisation

Grupo Gallego De Investigacion En Tumores Digestivos

Contact name

A person designed by the Sponsor

Public contact point

Organisation

Grupo Gallego De Investigacion En Tumores Digestivos

Contact name

A person designed by the Sponsor

Locations

2 EU/EEA countries · 41 investigational sites

By country

Investigational sites

Country notifications

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

Application history

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