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

Who is this study for? Patients with Child-Pugh class B7 cirrhosis
What treatments are being studied? Namodenoson
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Males and females at least 18 years of age.

• 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).

• HCC is advanced (i.e., treatment-refractory or metastatic) and no standard therapies are expected to be curative.

• HCC has progressed on at least 1, but no more than 2, prior systemic treatment regimens; prior locoregional therapy is allowed.

• Barcelona Clinic Liver Cancer (BCLC) Stage B or C (Llovet 1999).

• Prior HCC treatment was discontinued for at least 2 weeks prior to the Baseline Visit.

• Measurable disease by RECIST v1.1 (Eisenhauer 2009).

• ECOG PS of ≤ 1.

• 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).

⁃ 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.

⁃ Life expectancy of ≥ 6 weeks.

⁃ For women of childbearing potential, negative serum pregnancy test result.

⁃ Provide written informed consent to participate.

⁃ Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other trial-related procedures.

Locations
United States
Texas
Site 881
NOT_YET_RECRUITING
Dallas
Other Locations
Bosnia and Herzegovina
841 University Clinical Centre of Republic of Srpska
NOT_YET_RECRUITING
Banja Luka
843 University Clinical Hospital Mostar
NOT_YET_RECRUITING
Mostar
842 University Clinical Centre Sarajevo
NOT_YET_RECRUITING
Sarajevo
Bulgaria
831 Dept of Medical Oncology, Complex Oncology Ctr - Burgas EOOD
NOT_YET_RECRUITING
Burgas
835 First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD, Plovdiv
NOT_YET_RECRUITING
Plovdiv
Medical Center Leo Clinic EOOD Plovdiv
NOT_YET_RECRUITING
Plovdiv
834 Medical Oncology Dept, Univ Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Sofia
RECRUITING
Sofia
Israel
518 Rabin Medical Center Beilinson Hospital
RECRUITING
Petah Tikva
Poland
Site 858
NOT_YET_RECRUITING
Koszalin
Site 852
NOT_YET_RECRUITING
Krakow
Site 857
NOT_YET_RECRUITING
Mysłowice
Site 859
NOT_YET_RECRUITING
Przemyśl
Site 855
NOT_YET_RECRUITING
Warsaw
Site 850
NOT_YET_RECRUITING
Wroclaw
Republic of Moldova
872 IMSP Institute of Oncology
RECRUITING
Chisinau
Romania
802 Institutul Regional de Gastroenterologie si Hepatologie
RECRUITING
Cluj-napoca
807 IOCN, Medical Oncology
NOT_YET_RECRUITING
Cluj-napoca
809 Spitalul Clinic Judetean de Urgenta Constanta Oncology Dept
NOT_YET_RECRUITING
Constanța
801 Oncology Center Sf. Nectarie Medical Oncology
RECRUITING
Craiova
803 Oncolab SRL
RECRUITING
Craiova
805 Euroclinic lasi
RECRUITING
Iași
810 IRO Iasi-Clinica Oncologie Medicala
RECRUITING
Iași
808 Spitalul Clinic Pelican Oradea Oncology Department
RECRUITING
Oradea
804 Oncomed - Medical Oncology
RECRUITING
Timișoara
806 Oncocenter Oncologie Clinica SRL
RECRUITING
Timișoara
Serbia
821 Clinic for Gastroenterology and Hepatology, Military Medical Academy
NOT_YET_RECRUITING
Belgrade
822 Oncology Institute of Vojvodina
NOT_YET_RECRUITING
Kamenitz
823 Oncology Department, Health Center Kladovo
NOT_YET_RECRUITING
Kladovo
824 Univ Clin Centre Kragujevac, Dept of Oncology
NOT_YET_RECRUITING
Kragujevac
Slovakia
Site 867
NOT_YET_RECRUITING
Banská Bystrica
Site 865
NOT_YET_RECRUITING
Košice
Contact Information
Primary
Zivit Harpaz
Zivit@canfite.co.il
+972 3 924 1114
Time Frame
Start Date: 2023-03-15
Estimated Completion Date: 2026-10
Participants
Target number of participants: 471
Treatments
Experimental: Namodenoson (CF102)
Namodenoson 25 mg orally BID, until disease progression or unacceptable adverse events
Placebo_comparator: Placebo
Matching placebo orally BID, until disease progression or unacceptable adverse events
Related Therapeutic Areas
Sponsors
Leads: Can-Fite BioPharma

This content was sourced from clinicaltrials.gov