The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer (imPaCT-PRO)

March 28, 2022 updated by: Michalis Karamouzis

The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer: The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pancreatic cancer (PC) has the worst prognosis of any malignancy. Venous thromboembolism (VTE) occurs in 1:5 PC patients and is associated with significantly reduced progression-free survival (PFS). Phase III randomised controlled trials concluded that targeted thromboprophylaxis with low molecular weight heparins (LMWH) resulted in an 82% reduction in the relative risk of VTE without increasing major bleeding events, and that 11 patients were needed to be treated to prevent one VTE during chemotherapy. The benefits observed in the many of reported studies could not be accounted for by VTE prevention alone. Numerous experimental studies have demonstrated the antitumour, anti-metastatic and chemo-resistance reversal effect of LMWH.

The vast majority of the so far published evidence assessing the efficacy and safety of VTE prevention in ambulatory cancer patients is based on mixed patient populations with various types of cancers. Thus, current studies do not allow to estimate the real effect of long-term prophylaxis on clinical outcomes in selected homogeneous high-thrombotic risk patients.

An approach more specific to PC and restricted to advanced or metastatic patients is a modern and attractive strategy to assess the benefit of thromboprophylaxis in VTE prevention and beyond anticoagulation.

The objective of the imPaCT-PRO trial is to investigate the impact of thromboprophylaxis beyond anticoagulation in the improvement of the clinical outcomes in active PC patients receiving systemic anti-neoplasmatic treatment.

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 10678
        • Recruiting
        • Institute of Molecular Medicine and Biomedical Research
        • Contact:
          • Michalis Karamouzis, Prof
          • Phone Number: +30 213 0237967
          • Email: info@imibe.org
      • Athens, Attiki, Greece
        • Recruiting
        • Eygenideio Hospital, Oncology Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.

Exclusion Criteria:

  1. Subjects with contraindication to receive anticoagulant:

    1. Any hypersensitivity to anticoagulant or excipients.
    2. History of heparin-induced thrombocytopenia type II (HIT II).
    3. Active major bleeding or pre-diathesis for major bleeding
    4. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients treated with Innohep® and chemotherapy
The patients in this arm will receive Innohep and chemotherapy with Gemcitabine + Nab-Paclitaxel (NabG) as per clinical practice.
Drug: Innohep
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
Other Names:
  • Tinzaparin sodium
Active Comparator: Patients treated with chemotherapy
The patients in this arm will receive chemotherapy with Gemcitabine + Nab-Paclitaxel (NabG) as per clinical practice.
Drug: Chemotherapy: Gemcitabine + Nab-Paclitaxel
All patients will receive chemotherapy per clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS of patients
Time Frame: 12 months
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
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients experiencing at least one major bleeding event
Time Frame: Through study completion, an average of 2 years
% of patients experiencing at least one major bleeding event, according to the International Society on Thrombosis and Haemostasis (ISTH) criteria during the study per treatment arm.
Through study completion, an average of 2 years
% of patients experiencing any bleeding event
Time Frame: Through study completion, an average of 2 years
% of patients experiencing any bleeding event, including major, clinically relevant non-major bleeding (CRNMB) and minor bleeding events during the study per treatment arm.
Through study completion, an average of 2 years
VTE events
Time Frame: Through study completion, an average of 2 years
Incidence of VTE events, per event type, during the study per treatment arm
Through study completion, an average of 2 years
Patients with complete or partial response
Time Frame: Through study completion, an average of 2 years
ORR, defined as the percentage of patients with complete response (CR) or partial response (PR) based on RECIST criteria
Through study completion, an average of 2 years
Change from baseline in QoL
Time Frame: at 4 and 10 months
Change from baseline in QoL at 4 months and 10 months per treatment arm. QoL will be determined with the EORTC QLQ-C30 version 3.0. and EORTC QOL-PAN26 questionnaires according to the corresponding scoring manual
at 4 and 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michalis Karamouzis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • imPaCT-PRO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Innohep

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe