The impact of Thromboprophylaxis on Progression Free Survival of Patients with Advanced Pancreatic Cancer. The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institute Of Molecular Medicine And Biomedical Research

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-01-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

LEO Pharmaceuticals Hellas SA

External identifiers

EU CT number

2024-520043-17-00

EudraCT number

2021-005530-42

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

•Evaluate the impact of VTE prevention on progression-free survival (PFS).
•Investigate the efficacy of long term VTE prevention with simultaneously administration of tinzaparin during 1st line chemotherapy in patients undergoing anticancer treatment with NabG for locally advanced or metastatic PC.

Secondary objectives 4

1. Determine the safety and tolerability of tinzaparin in combination with NabG for locally advanced or metastatic PC during the study.
2. Determine overall response rates (ORR) according to Response Evaluation Criteria (Response Evaluation Criteria in Solid Tumors (RECIST) in advanced PC subjects during the study.
3. Determine quality of life (QoL).
4. Evaluation of the effect of VTE prevention on overall survival (OS) of patients with advanced PC during the study

Conditions and MedDRA coding

Thromboprophylaxis in patients with advanced pancreatic cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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.

Exclusion criteria 9

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. PFS of patients receiving thromboprophylaxis with tinzaparin, in comparison with the PFS of patients not receiving such prevention (primary endpoint).
2. 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).

Secondary endpoints 6

1. % 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.
2. % of patients experiencing any bleeding event, including major, clinically relevant non-major bleeding (CRNMB) and minor bleeding events during the study per treatment arm.
3. Incidence of VTE events, per event type, during the study per treatment arm.
4. ORR, defined as the percentage of patients with complete response (CR) or partial response (PR) based on RECIST criteria.
5. Change from baseline in QoL at 4 months and 10 months per treatment arm.
6. Overall Survival (OS) of patients receiving tinzaparin thromboprophylaxis compared to OS of patients not receiving such prophylaxis.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institute Of Molecular Medicine And Biomedical Research

Sponsor organisation

Institute Of Molecular Medicine And Biomedical Research

Address

Panepistimiou Street 56

City

Athens

Postcode

106 78

Country

Greece

Scientific contact point

Organisation

Institute Of Molecular Medicine And Biomedical Research

Contact name

Michalis Karamouzis

Public contact point

Organisation

Institute Of Molecular Medicine And Biomedical Research

Contact name

Michalis Karamouzis

Third parties 1

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications