The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer

NCT05178628 | Unknown Phase 3 DMC

• 1 other identifier: imPaCT-PRO-01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, randomized, multicenter, open-label, blinded-endpoint Phase III clinical trial to investigate the impact of thromboprophylaxis using innohep, beyond anticoagulation in the improvement of the clinical outcomes in active pancreatic cancer patients receiving systemic anti-neoplasmatic treatment. The number of patients that will be enrolled is 450. The enrollment period is 24 months and the follow up period is 10 months.

Conditions

Pancreatic Cancer; Thromboembolism

Keywords

Thromboprophylaxis; Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• PFS of patients

  PFS of patients receiving thromboprophylaxis with tinzaparin, in comparison with the PFS of patients not receiving such prevention

  12 months

• The number of VTE events during the trial

  All objectively confirmed VTE events during the study per treatment arm including symptomatic distal deep vein thrombosis (DVT), symptomatic or incidental proximal DVT (including iliac and cava thrombosis), symptomatic or incidental pulmonary embolism (PE) or both DVT and PE (co-primary endpoint) or fatal PE or vein thrombosis of rare localisation (i.e., splanchnic vein or cerebral vein thrombosis).

  12 months

Secondary Outcomes (5)

• % of patients experiencing at least one major bleeding event

  Through study completion, an average of 2 years

• % of patients experiencing any bleeding event

  Through study completion, an average of 2 years

• VTE events

  Through study completion, an average of 2 years

• Patients with complete or partial response

  Through study completion, an average of 2 years

• Change from baseline in QoL

  at 4 and 10 months

Study Arms (2)

Patients treated with Innohep® and chemotherapy

EXPERIMENTAL

The patients in this arm will receive Innohep and chemotherapy with Gemcitabine + Nab-Paclitaxel (NabG) as per clinical practice.

Drug: Innohep

Patients treated with chemotherapy

ACTIVE COMPARATOR

The patients in this arm will receive chemotherapy with Gemcitabine + Nab-Paclitaxel (NabG) as per clinical practice.

Drug: Chemotherapy: Gemcitabine + Nab-Paclitaxel

Interventions

Innohep DRUG

Patients will receive Tinzaparin sodium 20.000 Anti-Xa IU/ml in prefilled syringes. Administered at 175 Anti-Xa IU/Kgr of body weight, subcutaneously, once daily

Also known as: Tinzaparin sodium

Patients treated with Innohep® and chemotherapy

Chemotherapy: Gemcitabine + Nab-Paclitaxel DRUG

All patients will receive chemotherapy per clinical practice

Patients treated with chemotherapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Michalis Karamouzis: lead

Study Sites (2)

Institute of Molecular Medicine and Biomedical Research

Athens, Attica, 10678, Greece

RECRUITING

Eygenideio Hospital, Oncology Department

Athens, Attica, Greece

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Thromboembolism

Interventions

Tinzaparin; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Michalis Karamouzis

Model Details: Prospective, randomized, multicenter, open-label, blinded-endpoint Phase III clinical trial

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 5, 2022
• Study Start: February 10, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)