The prevention of thrombosis in patients with pancreatic cancer using Tinzapari

Phase 1

• Conditions: Thromboprophylaxis in patients with advanced pancreatic cancer; MedDRA version: 20.0Level: PTClassification code 10043607Term: ThrombosisSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 21.1Level: PTClassification code 10068067Term: Tumour thrombosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-005530-42-GR
• Lead Sponsor: Institute of Molecular Medicine and Biomedical Research (IMBE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1.Locally Advanced or metastatic PC (confirmed by the recommended histological and imaging methods).
2.Age = 18 years.
3.Planning to start 1st line chemotherapy with NabG.
4.Eastern Cooperative Group (ECOG) 0-2.
5.Life expectancy >6 months.
6.Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1.Subjects with contraindication to receive anticoagulant:
a. Any hypersensitivity to anticoagulant or excipients.
b. History of heparin-induced thrombocytopenia type II (HIT II).
c. Active major bleeding or pre-diathesis for major bleeding
d. Septic endocarditis.
2.Creatinine clearance <20 mL/min according to Cockcroft-Gault formula.
3.Platelet count < 50 G/L at inclusion.
4.Hepatic dysfunction defined as at least one of the following: AST and/or ALT > 5 x ULN, bilirubin > 2 x ULN.
5.Recent (< 1 month) oncological surgery, major abdominal or thoracic surgery, major orthopedic surgery, vascular surgery.
6.Recent (< 1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or hemorrhagic stroke.
7.Patients on chronic anticoagulation or on dual anti-platelet treatment.
8.Pregnancy/lactation or insufficient contraception during the study and up to 3 months after the study.
9.Severe concomitant disease that as per investigator’s judgement is not compatible with participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified