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Pancreatic CancerPhase 3imPaCT-PRONCT05178628

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

A Phase 3 study testing Innohep and Chemotherapy: Gemcitabine + Nab-Paclitaxel in people with Pancreatic Cancer and Thromboembolism, run by Michalis Karamouzis at 2 sites in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer, Thromboembolism
What is being tested?
Innohep and Chemotherapy: Gemcitabine + Nab-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
2 sitesGreece
Study dates
10 Feb 2022to 31 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • Platelet count < 50 G/L at inclusion.
  • 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.

Trial locations and contacts

2 sites in 1 country.

Greece2 sites, 2 recruiting

  • Institute of Molecular Medicine and Biomedical Research

    Athens, Attica, 10678

    Michalis Karamouzis, Prof, +30 213 0237967, info@imibe.org

    Recruiting

  • Eygenideio Hospital, Oncology Department

    Athens, Attica

    Michael Karamouzis, Prof., +302107208100, mkaramouz@med.uoa.gr

    Recruiting

Other trials in Greece

About this study

Official title: 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.

Read the 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.

Being tested
Innohep, Chemotherapy: Gemcitabine + Nab-Paclitaxel
Keywords
Thromboprophylaxis, Advanced Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms, Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InnohepDrug

    Also called Tinzaparin sodium

    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

  • Chemotherapy: Gemcitabine + Nab-PaclitaxelDrug

    All patients will receive chemotherapy per clinical practice

Study groups in NCT05178628
Study groupRoleWhat they receive
Patients treated with Innohep® and chemotherapyExperimentalThe patients in this arm will receive Innohep and chemotherapy with Gemcitabine + Nab-Paclitaxel (NabG) as per clinical practice.
Receives: Drug: Innohep
Patients treated with chemotherapyActive comparatorThe patients in this arm will receive chemotherapy with Gemcitabine + Nab-Paclitaxel (NabG) as per clinical practice.
Receives: Drug: Chemotherapy: Gemcitabine + Nab-Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS of patients

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

    Measured: 12 months

  2. 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).

    Measured: 12 months

Secondary outcomes (5)

  1. % of patients experiencing at least one major bleeding event

    % 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.

    Measured: Through study completion, an average of 2 years

  2. % of patients experiencing any bleeding event

    % of patients experiencing any bleeding event, including major, clinically relevant non-major bleeding (CRNMB) and minor bleeding events during the study per treatment arm.

    Measured: Through study completion, an average of 2 years

  3. VTE events

    Incidence of VTE events, per event type, during the study per treatment arm

    Measured: Through study completion, an average of 2 years

  4. Patients with complete or partial response

    ORR, defined as the percentage of patients with complete response (CR) or partial response (PR) based on RECIST criteria

    Measured: Through study completion, an average of 2 years

  5. Change from baseline in QoL

    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

    Measured: at 4 and 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start10 Feb 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, multicenter, open-label, blinded-endpoint Phase III clinical trial
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05178628
Sponsor's protocol ID
imPaCT-PRO-01
Acronym
imPaCT-PRO
Status last verified
Mar 2022
First submitted
15 Dec 2021
Last updated
29 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Innohep and Chemotherapy: Gemcitabine + Nab-Paclitaxel in people with Pancreatic Cancer and Thromboembolism, run by Michalis Karamouzis at 2 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS of patients (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05178628.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.

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