NCT05201404

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
471

participants targeted

Target at P75+ for phase_3 hepatocellular-carcinoma

Timeline
5mo left

Started Mar 2023

Geographic Reach
9 countries

32 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Mar 2023Oct 2026

First Submitted

Initial submission to the registry

December 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

2.9 years

First QC Date

December 21, 2021

Last Update Submit

April 28, 2025

Conditions

Hepatocellular CarcinomaCirrhosis

Keywords

Hepatocellular carcinomaHCCLiver cancerChild-Pugh Class B7 cirrhosisCPB7

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    Median duration of survival

    From the time of randomization until the date of death from any cause, assessed up to 60 months

Secondary Outcomes (4)

  • Progression-Free Survival (PFS)

    From the time of randomization until the date of disease progression or death from any cause, assessed up to 60 months

  • Objective Response Rate (ORR)

    Through study completion, with a median of 9 months

  • Incidence and nature of treatment-emergent adverse events

    Through study completion, with a median of 9 months

  • Pharmacokinetics (PK) of namodenoson in this population

    29 days

Other Outcomes (4)

  • Duration Of Response (DOR)

    Through study completion, with median of 9 months

  • Disease Control Rate (DCR)

    Through study completion, with median of 9 months

  • Quality of Life (QOL) using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)

    Through study completion, with a median of 9 months

  • +1 more other outcomes

Study Arms (2)

Namodenoson (CF102)

EXPERIMENTAL

Namodenoson 25 mg orally BID, until disease progression or unacceptable adverse events

Drug: Namodenoson

Placebo

PLACEBO COMPARATOR

Matching placebo orally BID, until disease progression or unacceptable adverse events

Drug: Placebo

Interventions

NamodenosonDRUG

Adenosine A3 Receptor (A3AR) agonist

Also known as: CF102
Namodenoson (CF102)
PlaceboDRUG

Control arm

Also known as: Inactive control
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +7 more criteria

You may not qualify if:

  • Receipt of \>2 prior systemic drug therapies for HCC.
  • 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.
  • Locoregional treatment within 4 weeks prior to the Baseline Visit.
  • Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.
  • Use of any investigational agent within 4 weeks prior to the Baseline Visit.
  • 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).
  • Child-Pugh Class A, B8/9, or C cirrhosis.
  • Hepatic encephalopathy.
  • Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit.
  • Uncontrolled or clinically unstable thyroid disease, per judgment of the Principal Investigator.
  • Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
  • Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
  • Liver transplant.
  • Active malignancy other than HCC.
  • Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4).
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Site 881

Dallas, Texas, 75201, United States

NOT YET RECRUITING

841 University Clinical Centre of Republic of Srpska

Banja Luka, Bosnia and Herzegovina

NOT YET RECRUITING

843 University Clinical Hospital Mostar

Mostar, Bosnia and Herzegovina

NOT YET RECRUITING

842 University Clinical Centre Sarajevo

Sarajevo, Bosnia and Herzegovina

NOT YET RECRUITING

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

Burgas, Bulgaria

NOT YET RECRUITING

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

Plovdiv, Bulgaria

NOT YET RECRUITING

Medical Center Leo Clinic EOOD Plovdiv

Plovdiv, Bulgaria

NOT YET RECRUITING

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

Sofia, Bulgaria

RECRUITING

518 Rabin Medical Center Beilinson Hospital

Petah Tikva, Israel

RECRUITING

872 IMSP Institute of Oncology

Chisinau, Moldova

RECRUITING

Site 858

Koszalin, Poland

NOT YET RECRUITING

Site 852

Krakow, Poland

NOT YET RECRUITING

Site 857

Mysłowice, Poland

NOT YET RECRUITING

Site 859

Przemyśl, Poland

NOT YET RECRUITING

Site 855

Warsaw, Poland

NOT YET RECRUITING

Site 850

Wroclaw, Poland

NOT YET RECRUITING

802 Institutul Regional de Gastroenterologie si Hepatologie

Cluj-Napoca, Romania

RECRUITING

807 IOCN, Medical Oncology

Cluj-Napoca, Romania

NOT YET RECRUITING

809 Spitalul Clinic Judetean de Urgenta Constanta Oncology Dept

Constanța, Romania

NOT YET RECRUITING

801 Oncology Center "Sf. Nectarie" Medical Oncology

Craiova, Romania

RECRUITING

803 Oncolab SRL

Craiova, Romania

RECRUITING

805 Euroclinic lasi

Iași, Romania

RECRUITING

810 IRO Iasi-Clinica Oncologie Medicala

Iași, Romania

RECRUITING

808 Spitalul Clinic Pelican Oradea Oncology Department

Oradea, Romania

RECRUITING

804 Oncomed - Medical Oncology

Timișoara, Romania

RECRUITING

806 Oncocenter Oncologie Clinica SRL

Timișoara, Romania

RECRUITING

821 Clinic for Gastroenterology and Hepatology, Military Medical Academy

Belgrade, Serbia

NOT YET RECRUITING

822 Oncology Institute of Vojvodina

Kamenitz, Serbia

NOT YET RECRUITING

823 Oncology Department, Health Center Kladovo

Kladovo, Serbia

NOT YET RECRUITING

824 Univ Clin Centre Kragujevac, Dept of Oncology

Kragujevac, Serbia

NOT YET RECRUITING

Site 867

Banská Bystrica, Slovakia

NOT YET RECRUITING

Site 865

Košice, Slovakia

NOT YET RECRUITING

Related Publications (4)

  • Bar-Yehuda S, Stemmer SM, Madi L, Castel D, Ochaion A, Cohen S, Barer F, Zabutti A, Perez-Liz G, Del Valle L, Fishman P. The A3 adenosine receptor agonist CF102 induces apoptosis of hepatocellular carcinoma via de-regulation of the Wnt and NF-kappaB signal transduction pathways. Int J Oncol. 2008 Aug;33(2):287-95.

    PMID: 18636149BACKGROUND

  • Cohen S, Stemmer SM, Zozulya G, Ochaion A, Patoka R, Barer F, Bar-Yehuda S, Rath-Wolfson L, Jacobson KA, Fishman P. CF102 an A3 adenosine receptor agonist mediates anti-tumor and anti-inflammatory effects in the liver. J Cell Physiol. 2011 Sep;226(9):2438-47. doi: 10.1002/jcp.22593.

    PMID: 21660967BACKGROUND

  • Stemmer SM, Benjaminov O, Medalia G, Ciuraru NB, Silverman MH, Bar-Yehuda S, Fishman S, Harpaz Z, Farbstein M, Cohen S, Patoka R, Singer B, Kerns WD, Fishman P. CF102 for the treatment of hepatocellular carcinoma: a phase I/II, open-label, dose-escalation study. Oncologist. 2013;18(1):25-6. doi: 10.1634/theoncologist.2012-0211. Epub 2013 Jan 8.

    PMID: 23299770BACKGROUND

  • Stemmer SM, Manojlovic NS, Marinca MV, Petrov P, Cherciu N, Ganea D, Ciuleanu TE, Pusca IA, Beg MS, Purcell WT, Croitoru AE, Ilieva RN, Natosevic S, Nita AL, Kalev DN, Harpaz Z, Farbstein M, Silverman MH, Bristol D, Itzhak I, Fishman P. Namodenoson in Advanced Hepatocellular Carcinoma and Child-Pugh B Cirrhosis: Randomized Placebo-Controlled Clinical Trial. Cancers (Basel). 2021 Jan 7;13(2):187. doi: 10.3390/cancers13020187.

    PMID: 33430312BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma, HepatocellularFibrosisLiver Neoplasms

Interventions

2-chloro-N(6)-(3-iodobenzyl)adenosine-5'-N-methyluronamide

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael H Silverman, MD

    BioStrategics Consulting Ltd

    STUDY DIRECTOR

Central Study Contacts

Zivit Harpaz

CONTACT

+972 3 924 1114Zivit@canfite.co.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel group, double-blinded, randomization in a 1:1 ratio to active versus placebo
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 21, 2022

Study Start

March 15, 2023

Primary Completion

February 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)PL(6)RO(10)SL(2)MO(1)US(1)BO(3)SE(4)BU(4)