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NCT05201404 | RECRUITING | Hepatocellular Carcinoma

Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
Sponsor:

Can-Fite BioPharma

Brief Summary:

This is a clinical trial in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B7 (CPB7) cirrhosis whose disease has progressed on at least 1st-line therapy. The trial will evaluate the efficacy and safety of namodenoson as compared to placebo.

Condition or disease

Hepatocellular Carcinoma

Cirrhosis

Intervention/treatment

Namodenoson

Placebo

Phase

PHASE3

Detailed Description:

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in patients with advanced HCC and CPB7 cirrhosis whose disease has progressed on at least 1st-line therapy. The trial will evaluate the efficacy and safety of namodenoson as compared to placebo. Patients will be randomly assigned in a 2:1 ratio to treatment with oral doses of either namodenoson 25 mg or matching placebo administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Tumor imaging will be performed every two cycles. Treatment will continue until the patient experiences PD or unacceptable drug-related intolerability. Patients will return for a follow-up visit 28 days after completion of the last dose of study drug, and survival data will be obtained for all randomized patients who consent to long-term follow-up. Patients who discontinue dosing and consent to follow-up will be followed indefinitely for survival status. Once the requisite number of events has been observed and the blind is broken for analysis of the trial results, any surviving patients who remain on blinded drug will be offered the opportunity to continue dosing with OL namodenoson 25 mg twice daily indefinitely.

Study Type : INTERVENTIONAL
Estimated Enrollment : 471 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
Actual Study Start Date : 2023-03-15
Estimated Primary Completion Date : 2026-02
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Males and females at least 18 years of age.
  • 2. Diagnosis of HCC
    • * For patients without cirrhosis at the time of diagnosis, histologic confirmation is required (archival tissue is acceptable).
    • * For patients with underlying cirrhosis at the time of diagnosis, diagnosis of HCC established according to the American Association for the Study of Liver Diseases Practice Guideline algorithm (Marrero 2018).
    • 3. HCC is advanced (i.e., treatment-refractory or metastatic) and no standard therapies are expected to be curative.
    • 4. HCC has progressed on at least 1, but no more than 2, prior systemic treatment regimens; prior locoregional therapy is allowed.
    • 5. Barcelona Clinic Liver Cancer (BCLC) Stage B or C (Llovet 1999).
    • 6. Prior HCC treatment was discontinued for at least 2 weeks prior to the Baseline Visit.
    • 7. Measurable disease by RECIST v1.1 (Eisenhauer 2009).
    • 8. ECOG PS of ≤ 1.
    • 9. Cirrhosis classified as CPB7; if ascites is used as a scoring criterion, it must be classified as Grade ≥2 by the Clinical Practice Guidelines of the European Association for the Study of the Liver (EASL 2010).
    • 10. The following laboratory values must be documented within ten days prior to the first dose of study drug
      • * Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
      • * Platelet count at least 75 × 10\^9/L
      • * Creatinine clearance at least 50 mg/dL (estimated glomerular filtration rate by the Cockcroft-Gault or the Modification of Diet in Renal Disease methods)
      • * AST and ALT ≤ 5 × the upper limit of normal (ULN)
      • * Total bilirubin ≤ 3.0 mg/dL
      • * Serum albumin ≥ 2.8 g/dL.
      • 11. Life expectancy of ≥ 6 weeks.
      • 12. For women of childbearing potential, negative serum pregnancy test result.
      • 13. Provide written informed consent to participate.
      • 14. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other trial-related procedures.
      Exclusion Criteria
      • 1. Receipt of \>2 prior systemic drug therapies for HCC.
      • 2. Receipt of systemic cancer therapy, immunomodulatory drug therapy, immunosuppressive therapy, or corticosteroids \> 20 mg/day prednisone or equivalent within 14 days prior to the Baseline Visit or concurrently during the trial.
      • 3. Locoregional treatment within 4 weeks prior to the Baseline Visit.
      • 4. Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.
      • 5. Use of any investigational agent within 4 weeks prior to the Baseline Visit.
      • 6. Concomitant use of P-glycoprotein (P-gp)/breast cancer resistance protein (BCRP) inhibitors and/or substrates with a narrow therapeutic index unless the medication can be taken at least 3 hours before or after taking the investigational product (see Section 12.2).
      • 7. Child-Pugh Class A, B8/9, or C cirrhosis.
      • 8. Hepatic encephalopathy.
      • 9. Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit.
      • 10. Uncontrolled or clinically unstable thyroid disease, per judgment of the Principal Investigator.
      • 11. Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
      • 12. Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
      • 13. Liver transplant.
      • 14. Active malignancy other than HCC.
      • 15. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4).
      • 16. Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
      • 17. History of, or ongoing, cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to \> 470 msec (patients with bundle branch block will not be excluded for QTc reasons).
      • 18. Pregnant or lactating female.
      • 19. Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Investigator, are effective and adequate for the patient's circumstances while on study drug.
      • 20. Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable, or barrier method) while on study drug and for 3 months afterward.
      • 21. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed consent process and/or with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator's opinion, would make the patient inappropriate for entry into this trial.
Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis

Location Details

NCT05201404

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Texas

Site 881

Dallas, Texas, United States, 75201

NOT YET RECRUITING

Bosnia and Herzegovina,

841 University Clinical Centre of Republic of Srpska

Banja Luka, Bosnia and Herzegovina,

NOT YET RECRUITING

Bosnia and Herzegovina,

843 University Clinical Hospital Mostar

Mostar, Bosnia and Herzegovina,

NOT YET RECRUITING

Bosnia and Herzegovina,

842 University Clinical Centre Sarajevo

Sarajevo, Bosnia and Herzegovina,

NOT YET RECRUITING

Bulgaria,

831 Dept of Medical Oncology, Complex Oncology Ctr - Burgas EOOD

Burgas, Bulgaria,

NOT YET RECRUITING

Bulgaria,

835 First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD, Plovdiv

Plovdiv, Bulgaria,

NOT YET RECRUITING

Bulgaria,

Medical Center Leo Clinic EOOD Plovdiv

Plovdiv, Bulgaria,

RECRUITING

Bulgaria,

834 Medical Oncology Dept, Univ Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD, Sofia

Sofia, Bulgaria,

RECRUITING

Israel,

518 Rabin Medical Center Beilinson Hospital

Pumpkin, Israel,

RECRUITING

Moldova, Republic of,

872 IMSP Institute of Oncology

Chisinau, Moldova, Republic of,

NOT YET RECRUITING

Poland,

Site 858

Koszalin, Poland,

NOT YET RECRUITING

Poland,

Site 852

Cracow, Poland,

NOT YET RECRUITING

Poland,

Site 857

Mysłowice, Poland,

NOT YET RECRUITING

Poland,

Site 859

Industry, Poland,

NOT YET RECRUITING

Poland,

Site 855

Warsaw, Poland,

NOT YET RECRUITING

Poland,

Site 850

Wroclaw, Poland,

RECRUITING

Romania,

802 Regional Institute of Gastroenterology and Hepatology

Cluj-Napoca, Romania,

NOT YET RECRUITING

Romania,

807 IOCN, Medical Oncology

Cluj-Napoca, Romania,

NOT YET RECRUITING

Romania,

809 County Emergency Clinical Hospital Constanta Oncology DEPT

Constant, Romania,

RECRUITING

Romania,

801 Oncology Center "Sf. Nectarie" Medical Oncology

Craiova, Romania,

RECRUITING

Romania,

803 oncolab etc.

Craiova, Romania,

RECRUITING

Romania,

805 Euroclinic lasi

IASI, Romania,

RECRUITING

Romania,

810 Iro Iasi Medical Oncology Clinic

IASI, Romania,

RECRUITING

Romania,

808 Pelican Clinical Hospital Oradea Oncology Department

Oradea, Romania,

RECRUITING

Romania,

804 Oncomed - Medical Oncology

Timisoara, Romania,

RECRUITING

Romania,

806 ONCOCENTER ONCOLOGY CLINICA SRL

Timisoara, Romania,

NOT YET RECRUITING

Serbia,

821 Clinic for Gastroenterology and Hepatology, Military Medical Academy

Belgrade, Serbia,

NOT YET RECRUITING

Serbia,

823 Oncology Department, Health Center Kladovo

Kladovo, Serbia,

NOT YET RECRUITING

Serbia,

824 Univ Clin Centre Kragujevac, Dept of Oncology

Kragujevac, Serbia,

NOT YET RECRUITING

Serbia,

822 Oncology Institute of Vojvodina

Srem Kamenica, Serbia,

NOT YET RECRUITING

Slovakia,

Site 867

Banská Bystrica, Slovakia,

NOT YET RECRUITING

Slovakia,

Site 865

Košice, Slovakia,