TINzaparin Prophylaxis in Patients With Metastatic Colorectal Cancer

Korábbi kezelés

• Contraindication to tinzaparin, or other heparins:
  • Allergy (or hypersensitivity) to heparin, tinzaparin, other LMWHs, or pork products.
  • History or presence of heparin-induced (type II) thrombocytopenia.
  • Have or have had an epidural catheter or a traumatic spinal puncture within the previous 7 days.
• Lesions or conditions at increased risk of clinically significant bleeding, including:
  • Previously diagnosed/treated VTE ≤ 28 days prior to randomization.
  • Active ulcer disease.
  • Diagnosed cerebral metastases.
  • Stroke within the prior 6 months.
  • History of central nervous system (CNS) or intraocular bleeding.
• 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.

Más betegség

• 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
• 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.

Laborértékek

• Prothrombin time (PT) (International normalized ratio [INR] >1.5 for any reason) or aPTT >2 times control value.
• Active major bleeding or conditions predisposing to major bleeding. a major bleeding is defined as one that meets one of the following three criteria:
  • occurring in a critical area or organ (for example, intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular or pericardial, intrauterine or intramuscular with compartment syndrome),
  • causing a decrease in hemoglobin levels of 2 g/l (1.24 mmol/l) or more, or that requires a transfusion of two or more units of whole blood or packed red blood cells.
• Acute or chronic renal insufficiency with Creatinine clearance < 30 ml / min.
• Platelet count < 80.000 /ml at the time of inclusion.
• Severe liver insufficiency as defined by clinical manifestations of ascites, cirrhosis, encephalopathy and/or jaundice and/or biochemical abnormalities in liver function tests including:
  • elevated levels of total bilirubin (> 2 times the upper limit normal [ULN]),
  • elevated liver transaminases (> 2 times the ULN; > 5 in case of hepatic metastasis).
• 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.

Egyéb

• Patients who weigh < 50 Kg.

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