EMPAGLIFLOZIN for Anthracycline-induced cardiotoxicity|Cancer

Inclusion criteria

• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2."}
• {"criterion_text":"- ≥ 18 years of age at the time of signing the informed consent."}
• {"criterion_text":"- Known neoplastic disease prior to the initiation of chemotherapy with a high dose of anthracyclines (doxorubicin ≥ 240 mg / m2 b.w. or epirubicin ≥ 360 mg / m2 b.w.)"}
• {"criterion_text":"- No history of heart failure (left ventricular ejection fraction ≥ 50% as assessed by echocardiography)."}
• {"criterion_text":"- Ability to give written informed consent and comply with protocol requirements."}
• {"criterion_text":"- Women of child-bearing age must have a negative serum or urine pregnancy test."}
• {"criterion_text":"- All males and females must consent to the use of effective contraception throughout the study period and after study medication is discontinued."}
• {"criterion_text":"- Women of childbearing potential (WOCBP) must meet and/or agree to all the following for contraception: a. use 2 effective methods of contraception (abstinence, IUD, oral contraceptive, or double barrier device) from informed consent and for at least 6 months after study drug discontinuation. b. agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period."}
• {"criterion_text":"- Sexually active men and their sexual partners must use effective methods of contraception from the moment they sign their informed consent to participate in the study and for at least 3 months after discontinuation of the study drug."}

Exclusion criteria

• {"criterion_text":"- History of heart failure."}
• {"criterion_text":"- Presence of any disease with a life expectancy <1 year in the opinion of the Investigator."}
• {"criterion_text":"- Treatment with any SGLT-2 inhibitor for up to 3 months prior to study enrolment."}
• {"criterion_text":"- Pregnant or lactating females."}
• {"criterion_text":"- Drug or alcohol abuse."}
• {"criterion_text":"- Suspected non-compliance and irregular use of study drug."}
• {"criterion_text":"- Inability to perform cardiac MRI due to, e.g., claustrophobia, weight> 120 kg."}
• {"criterion_text":"- Left ventricle systolic dysfunction assessed by echocardiography (LVEF<50%)."}
• {"criterion_text":"- Significant valve disease"}
• {"criterion_text":"- Previous chemotherapy or radiation to the chest."}
• {"criterion_text":"- Symptomatic hypotension and / or SBP <100 mmHg at Visit 1 or Visit 2."}
• {"criterion_text":"- Liver disease, as determined by Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), or alkaline phosphatase levels above 3 x upper limit of normal (ULN) at Visit 1."}
• {"criterion_text":"- Renal impairment, defined as eGFR <20 mL / min / 1.73 m2 or dialysis requirement, as determined at Visit 1."}
• {"criterion_text":"- History of ketoacidosis."}
• {"criterion_text":"- Gastrointestinal surgery or gastrointestinal disturbance that could impair drug absorption."}

Primary endpoints

• {"endpoint_text":"- Time to first event of left ventricular systolic dysfunction. Criterion for the diagnosis of left ventricular systolic dysfunction in echocardiography: reduction of left ventricular ejection fraction (LVEF)> 10 percentage points from baseline to <50%","definition_or_measurement_approach":"Diagnosis by echocardiography: reduction of LVEF > 10 percentage points from baseline to <50%; endpoint measured as time to first event."}

Secondary endpoints

• {"endpoint_text":"- Overall response rate 1. Composite secondary endpoint • all-cause death • cardiovascular death • myocardial infarction • stroke 2. Other: • decrease in GLS (global longitudinal strain) • structural myocardial alterations in CMR • changes in the concentration of biomarkers in blood samples (Troponin T, NTproBNP)","definition_or_measurement_approach":"Composite endpoint includes all-cause death, cardiovascular death, myocardial infarction, stroke. Other measures include decrease in GLS (global longitudinal strain), structural myocardial alterations on cardiac MRI (CMR), and changes in blood biomarkers (Troponin T, NT-proBNP)."}
• {"endpoint_text":"- Incidence and intensity of Adverse events (AEs), including serious AEs (SAEs).Withdrawal from study drug due to AEs • Clinically relevant changes in laboratory assessments from baseline. • Clinically relevant new finding or worsening of existing condition on physical examination • Assessment of vital status. AESIs: ketoacidosis, lower limb amputation • Laboratory parameters: hematology, serum chemistry, lipids profile, and urinalysis.Physical Examination •Vital Status: SBP, DBP and pulse rate","definition_or_measurement_approach":"Safety endpoints: incidence and severity of AEs/SAEs, withdrawals due to AEs, clinically relevant lab changes (hematology, chemistry, lipids, urinalysis), physical examination findings, vital signs (SBP, DBP, pulse). AESIs specified include ketoacidosis and lower limb amputation."}

Poland

Earliest CTIS Part Ii Submission Date

01-07-2024

Latest Decision Or Authorization Date

21-10-2025

Processing Time Days

478

Number Of Sites

2

Number Of Participants

220

Primary sponsor

Full Name

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland