Remaxol® in Patients with Drug-induced Liver Injuries During Cancer Chemotherapy

Launched by POLYSAN SCIENTIFIC & TECHNOLOGICAL PHARMACEUTICAL COMPANY · Mar 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of two medications, Remaxol® and Ademethionine, in patients who have experienced liver injuries caused by cancer chemotherapy. The goal is to see if these treatments can help protect the liver and allow patients to continue their chemotherapy successfully. The trial is currently recruiting participants aged 40 to 70 who have a confirmed diagnosis of cancer and are undergoing specific types of chemotherapy known to affect the liver.

To be eligible, patients must have liver damage that prevents them from continuing their chemotherapy safely. Participants will receive Remaxol® as an infusion for 12 days or Ademethionine for 14 days, depending on the treatment plan. It's important to note that certain individuals, such as those who are pregnant, have severe mental health issues, or specific chronic diseases, may not qualify for the trial. If you or a loved one is interested in participating, it’s essential to discuss this with a healthcare provider to understand the potential benefits and risks involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * The study can include all patients who are scheduled, at a physician's discretion, to receive the therapy with the drug Remaxol®, solution for infusions, or Ademethionine, lyophilizate for solution for intravenous and intramuscular injection, according to the approved instruction for the medical use of the drug and established clinical practice of a healthcare facility, and who meet all the following criteria:
• • 1. Males and females aged from 40 to 70 years inclusive.
• • 2. Verified diagnosis of neoplasm (morphologically proven).
• • 3. Receiving the course polychemotherapy (PCT).
• 4. PCT regimens with pronounced hepatotoxic effects, which use drugs from the following pharmacologic classes:
• • 1. Competitive antagonists (5-Fluorouracil, Methotrexate etc.);
• • 2. Alkylating agents (Cyclophosphamide, Oxaliplatin etc.);
• • 3. Antitumor antibiotics (Doxorubicin, Bleomycin etc.);
• • 4. Drugs influencing tubulin (Trabectedin, Paclitaxel etc.);
• • 5. Topoisomerase inhibitors (Irinotecan, Etoposide etc.).
• • <!-- -->
• • 1. Contraindications for the continuation of PCT at the time of a visit to a physician for its continuation, because of developed hepatotoxicity.
• • 2. Stage of the treatment: supporting, hepatoprotective and detoxication therapy to correct hepatotoxicity developed during PCT, to remove it and continue the chemotherapeutic treatment.
• 3. A patient is scheduled to receive one of the following infusion therapies with the following regimen, as part of the routine clinical practice:
• • 4. It is planned to administer the drug Remaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12 days.
• • 5. It is planned to administer the drug Ademethionine, lyophilisate for solution for intravenous and intramuscular injection, by intravenous drop infusion in the dose of 800 mg/day, on everyday basis for 14 days. ECOG performance status score: 1-2 inclusive (Karnofsky score: 50-80 %).
• • 6. Hepatotoxicity grade according to the classification of the US National Cancer Institute (NCCN, CTC) - 2 and 3.
• • 7. Scores by selected parameters of CTCAE (National Cancer Institute Common Toxicity Criteria for Adverse Events) scale - I and II.
• • 8. Patient's written consent for participation in the study according to the current legislation.
• Exclusion Criteria:
• • 1. Pregnancy, breast-feeding.
• • 2. Mental disorders requiring psychiatric observation.
• • 3. Chronic alcohol abuse and/or substance abuse.
• • 4. HIV-infection, syphilis, virus hepatitis, autoimmune hepatitis, storage diseases, tuberculosis.
• • 5. Administration of monoclonal antibodies, (multi)kinase inhibitors during the PCT session immediately preceding this study.
• • 6. Administration of methionine-, Ademetionine-, malate- and/or succinate-containing medicines during the last month.
• • 7. Prescription of other malate-, succinate, or methionine-containing medicines (mexidol, cytoflavin, etc.).
• • 8. Decompensation of any severe/clinically apparent somatic diseases of the kidneys, liver, cardiovascular system, respiratory system, endocrine system, etc., as decided by the investigating physician.
• • 9. Contraindications mentioned in the approved instructions for use of medicines applied in the study (idiosyncrasy to the product components).
• • 10. Disease or use of medicines, which, in the doctor's opinion, can influence safety, tolerability and efficiency of the study medicines.