Overview
Sponsor-declared trial summary
We are investigating the efficacy and safety of enhanced thromboprophylaxis during neoadjuvant treatments for pancreatic cancer.
Neoadjuvant-treated pancreatic cancer patients are at increased risk of thrombosis. Our aim is to investigate the impact of thromboprophylaxis administered during neoadjuvant treatments on the risk of vascular events and survival prognosis in pancreatic cancer patients in a randomized prospective study.
Key facts
- Sponsor
- HUS-Yhtymae, University Of Helsinki
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512475-12-01
- EudraCT number
- 2019-002496-33
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis
Neoadjuvant-treated pancreatic cancer patients are at increased risk of thrombosis. Our aim is to investigate the impact of thromboprophylaxis administered during neoadjuvant treatments on the risk of vascular events and survival prognosis in pancreatic cancer patients in a randomized prospective study.
Secondary objectives 1
- In addition, we will analyze the association between coagulation-related laboratory variables during neoadjuvant treatment and treatment response as well as postoperative prognosis in our study cohort to identify variables that indicate a particularly high risk of thrombosis. Our hypothesis is that favorable neoadjuvant treatment response is associated with decreased coagulation activation.
Conditions and MedDRA coding
We are investigating the efficacy and safety of enhanced thromboprophylaxis during neoadjuvant treatments for pancreatic cancer.
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-512475-12-00 | Thrombosis prophylaxis and coagulation activation during neoadjuvant treatment in pancreatic cancer - Association to prognosis and recurrence. | HUS-Yhtymae |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- An adult pancreatic cancer patient for whom neoadjuvant treatments are being planned due to pancreatic cancer.
Exclusion criteria 1
- The study excludes patients, if they have contraindications for using tinzaparin, are already on anticoagulant medication, have had any other active cancer in the past five years or have severe kidney failure or bleeding tendencies.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- As primary endpoints, we collect venous and arterial thrombotic events, bleeding complications, as well as information on disease progression and feasible time and cause of death. Patients are followed for at least five years or until death.
Secondary endpoints 1
- We will observe changes in the patient's coagulation activation from venous blood samples during neoadjuvant treatment and disease follow-up. Blood samples will be taken before the start of neoadjuvant treatments, between chemotherapy cycles, after neoadjuvant treatments, and (or after the start of palliative treatments if surgery is not feasible) at months 1, 3, 6, 12, 15, 24, and 36 along with other scheduled blood tests.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
innohep® 3500 anti-Xa IU injektioneste, liuos, kerta-annosruiskussa
PRD4630777 · Product
- Active substance
- Tinzaparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 3500 anti-Xa IU anti-Xa activity International Unit(s)
- Max total dose
- 3500 anti-Xa IU anti-Xa activity International Unit(s)
- Max treatment duration
- 26 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AB10 — TINZAPARIN
- Marketing authorisation
- 33265
- MA holder
- LEO PHARMA A/S
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Inhixa 6,000 IU (60 mg)/0.6 mL solution for injection in pre-filled syringe
PRD7926753 · Product
- Active substance
- Enoxaparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 26 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AB05 — ENOXAPARIN
- Marketing authorisation
- EU/1/16/1132/016
- MA holder
- TECHDOW PHARMA NETHERLANDS B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Hanna Seppänen
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Hanna Seppänen
University Of Helsinki
- Sponsor organisation
- University Of Helsinki
- Address
- Yliopistonkatu 3
- City
- Helsinki
- Postcode
- 00100
- Country
- Finland
Scientific contact point
- Organisation
- University Of Helsinki
- Contact name
- Hanna Seppänen
Public contact point
- Organisation
- University Of Helsinki
- Contact name
- Hanna Seppänen
Sponsor responsibilities
- Article 77 compliance
- HUS-Yhtymae
- Contact point sponsor
- HUS-Yhtymae
- Article 77 implementation
- HUS-Yhtymae
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 214 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2024-11-27 | 2024-11-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol PC NAT AK 4Sep2023_For publication | 1 |
| Recruitment arrangements (for publication) | Flow-chart | 1 |
| Subject information and informed consent form (for publication) | Tiedote+suostumus kliinisesta laaketutkimuksesta NAT+tintsapariini | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Valmisteyhteenveto_Inhixa 8 000 IU_80 mg injektioneste | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Valmisteyhteenveto_Innohep 3500 anti-Xa IU injektioneste | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-30 | Finland | Acceptable 2024-11-27
|
2024-11-27 |