Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Thromboembolism

Disease Progression

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Fibrinolytic Agents

Anticoagulants

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

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

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

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

Innohep

All patients will receive chemotherapy per clinical practice

Chemotherapy: Gemcitabine + Nab-Paclitaxel

Michalis Karamouzis, Prof

Michael Karamouzis, Prof.

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.

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.

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

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

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

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

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).

% 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.

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

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

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

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

Michalis Karamouzis

Prof. Michalis Karamouzis

Nervous System Diseases

Brain Neoplasms

Body Weight

Venous Thromboembolism

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Heparin

Calcium heparin

The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.

James Vredenburgh, MD

To determine the safety of prophylaxis with Tinzaparin low molecular weight heparin in primary brain tumor patients. 2. To determine the incidence of deep venous thrombosis or pulmonary embolism in brain tumor patients who will be receiving Tinzaparin as primary prophylaxis. 3. To determine the overall survival of patients with malignant glioma who receive Tinzaparin. 4. To determine the bone density before and after prophylactic Tinzaparin.

Many patients with brain tumors develop thinning of the bones and weak bones, called osteoporosis. At baseline (or within 4 weeks of enrollment onto study) and 12 months the subject will have a bone densitometry study (DEXA-Scan) which is a test to determine bone density (the measure of the strength and thickness of bones) by using x-ray techniques.

A single arm pilot trial will be performed with newly diagnosed pathologically confirmed malignant glioma patients. The patients will receive low molecular weight heparin (Tinzaparin), which will begin at least 48 hours after craniotomy or stereotactic biopsy, but no later than four weeks after the most recent surgery.

The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.

The primary analysis will be conducted at six months and the safety will be determined by the incidence of clinically significant bleeding, ≥ grade III/IV CNS hemorrhage or grade II hemorrhage elsewhere. The Tinzaparin will be discontinued for any grade II or higher hemorrhage, except CNS hemorrhage and patients with asymptomatic CNS hemorrhage seen on a scan (grade III) at study entry will stay on Tinzaparin, except if the CNS hemorrhage expands or there is a new hemorrhage, in which case the Tinzaparin will be discontinued. For patients without a CNS hemorrhage at entry, a new asymptomatic CNS hemorrhage (grade III), or a CNS hemorrhage with symptoms (≥ grade IV) will result in discontinuation of the Tinzaparin. If the patient does not have any hemorrhage, the Tinzaparin will be continued for an additional six months with the second analysis performed at 12 months. Patients may stay on Innohep as long as they are benefiting and there are no adverse reactions necessitation stopping therapy. Patients will continue to having the same labs and clinical follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer	NCT05178628	Pancreatic Canc... Thromboembolism	Innohep Chemotherapy: G...	18 Years -	Institute of Molecular Medicine and Biomedical Research
Innohep for Prophylaxis of Venous Thromboembolism in Brain Tumor Patients	NCT00629447	Primary Brain T...	Innohep	18 Years -	Duke University
The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer	NCT05178628	Pancreatic Canc... Thromboembolism	Innohep Chemotherapy: G...	18 Years -	Institute of Molecular Medicine and Biomedical Research

Spots Global Cancer Trial Database for innohep

Every month we try and update this database with for innohep cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for innohep

Every month we try and update this database with for innohep cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for innohep cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.