~157 spots leftby Mar 2026

Namodenoson for Liver Cancer

(LIVERATION Trial)

Recruiting in Palo Alto (17 mi)
+55 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Can-Fite BioPharma
Must not be taking: Immunosuppressants, Corticosteroids, P-gp/BCRP inhibitors
Disqualifiers: HIV/AIDS, Liver transplant, Hypertension, others
Pivotal Trial (Near Approval)
Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests an oral medication on patients with advanced liver cancer who have not responded to previous treatments. The goal is to see if this medication can slow down or stop the growth of cancer cells in the liver. The medication is being developed to treat liver cancer, where longer survival was observed in patients with advanced liver disease.
Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot use certain drugs like systemic cancer therapies, immunosuppressive drugs, or corticosteroids above a certain dose within 14 days before starting the trial. Also, some medications must be timed carefully around the trial drug.

What makes the drug Namodenoson unique for liver cancer treatment?

Namodenoson is unique because it targets specific receptors in the liver, potentially offering a more targeted approach compared to traditional chemotherapy, which often affects the whole body and can cause significant side effects.

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Eligibility Criteria

Adults with advanced liver cancer (hepatocellular carcinoma) and specific liver cirrhosis (Child-Pugh Class B7), who have tried at least one treatment but no more than two, can join this trial. They should be in a condition to follow the trial procedures and not have had certain treatments or surgeries recently. Women must not be pregnant and participants must agree to use effective contraception.

Inclusion Criteria

My liver condition is classified as moderate.
My liver cancer is advanced and cannot be cured with standard treatments.
I stopped my liver cancer treatment at least 2 weeks ago.
+11 more

Exclusion Criteria

Presence of severe medical or psychiatric conditions that may increase risk or interfere with trial participation
My liver disease is classified as cirrhosis.
Specific contraceptive requirements for women of childbearing potential and men
+5 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral doses of either namodenoson 25 mg or matching placebo twice daily for consecutive 28-day cycles

Indefinite, until disease progression or unacceptable adverse events
Regular evaluations for safety and tumor imaging every two cycles

Follow-up

Participants return for a follow-up visit 28 days after the last dose of study drug, and survival data is collected

4 weeks
1 visit (in-person)

Open-label extension (optional)

Surviving patients who remain on blinded drug are offered the opportunity to continue dosing with open-label namodenoson 25 mg twice daily indefinitely

Indefinite

Participant Groups

The trial is testing Namodenoson, a new potential drug for advanced liver cancer, against a placebo to see if it's safe and works better. Participants will either receive Namodenoson or a placebo without knowing which one they are getting.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Namodenoson (CF102)Experimental Treatment1 Intervention
Namodenoson 25 mg orally BID, until disease progression or unacceptable adverse events
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo orally BID, until disease progression or unacceptable adverse events

Namodenoson is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Namodenoson for:
  • None (currently in Phase III trials for hepatocellular carcinoma)
🇺🇸 Approved in United States as Namodenoson for:
  • None (currently in Phase III trials for hepatocellular carcinoma)

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Site 881Dallas, TX
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Who Is Running the Clinical Trial?

Can-Fite BioPharmaLead Sponsor

References

Hepatic perfusion with FUdR utilizing an implantable system in patients with liver primary cancer or metastatic cancer confined to the liver. [2019]Nineteen patients with colorectal adenocarcinoma, three with cholangiocarcinoma, two with hepatocellular carcinoma, and one with carcinoid were treated with hepatic artery infusion chemotherapy. An implantable pump system was used to deliver floxuridine (FUdR), starting at 400 mg for 2 weeks with 2 weeks of rest. Eleven of 15 (73%) measurable patients with colorectal carcinoma responded. Of 6 complete responses, 4 were documented by laparotomy, including 1 with cholangiocarcinoma. Toxicity included dyspepsia and elevated liver function tests in all patients, gastric ulcer in 2, cholecystitis in 2, and sclerosing cholangitis in 3. Overall median survival for the colon cancer patients has not been reached at 16 months. Regional disease was controlled in the majority of patients treated with this regimen with acceptable toxicity and good quality of life.
Systemic therapy for colorectal cancer: an overview. [2013]The systemic management of patients with colorectal cancer continues to center on the use of 5-fluorouracil (5-FU). In the setting of metastatic disease, parenteral 5-FU has been shown to be superior to oral 5-FU; however, survival duration seems similar regardless of whether parenteral 5-FU is administered in a "loading schedule," weekly, or in a continuous-infusion regimen. The addition of other cytotoxic agents, such as semustine (methyl-CCNU) and/or mitomycin C, to 5-FU does not appear to be beneficial. Recent efforts have been directed toward enhancing the activity of 5-FU by (1) increasing its incorporation into RNA through pretreatment with methotrexate or phosphonoacetyl-L-aspartate (PALA), (2) enhancing DNA synthesis inhibition via the concomitant administration of folinic acid, and (3) an undetermined modulatory action by the addition of alpha-interferon. These pharmacologic approaches are being compared in ongoing cooperative group trials. The results of five randomized trials assessing the value of intra-arterial, hepatic infusions of 5-FU or 5-fluorodeoxyuridine have demonstrated that regional chemotherapy increases the likelihood of a hepatic response when compared with systemic treatment, but has little effect on survival and is associated with significant toxicity. Recent adjuvant chemotherapy trials have indicated both a decrease in recurrence and a prolongation in survival when chemotherapy (5-FU + levamisole) is administered to patients with stage C colon cancer; and combined radiation therapy and chemotherapy is given to patients with stages B2 and C rectal cancer.
Adjuvant therapy of poor prognosis colon cancer with levamisole: results of an EORTC double-blind randomized clinical trial. [2019]From 1978 to 1985, 297 patients were entered in a double-blind randomized trial comparing levamisole to placebo as adjuvant therapy of Dukes' C carcinoma of the colon. Therapy consisted of from two to five tablets of 50 mg levamisole (or placebo) twice a week, depending on bodyweight for 1 year. Levamisole was generally well tolerated, with only four reversible cases of agranulocytosis reported among 129 patients. The trial failed to show a benefit of levamisole on disease-free survival (P = 0.53) or on survival (P = 0.35). There was no difference between the two treatment groups in terms of number of disease relapses, sites of relapse, or time to relapse. The proportion of patients still alive at 5 years was 51 per cent (standard error, 5.5 per cent) in the levamisole group versus 39 per cent (standard error, 5.4 per cent) in the placebo group.
[Adjuvant treatment of colonic carcinoma]. [2013]After many years of negative trials of adjuvant chemotherapy in colon cancer, two studies in the years 1989 and 1990 of the NCCTG and the Intergroup Trial, respectively showed a significant reduction of relapse and improved survival in patients treated with 5-FU and levamisole in an adjuvant setting. The absolute and relative reductions in 5-year-relapse and death rates were approximately 35% and 17%, respectively. Intraportal perfusion of the liver in an adjuvant perioperative setting seems to be of similar benefit. Preliminary data of the adjuvant therapy with 5-FU and folinic acid also show that this combination seems to have at least the same efficacy as the current standard 5-FU/levamisole in the adjuvant therapy of colon cancer. At the current time, patients with colon cancer of Dukes stage C should be offered adjuvant chemotherapy with 5-FU/levamisole outside of clinical studies.
Pharmacological Effects of the Ruthenium Complex NAMI-A Given Orally to CBA Mice With MCa Mammary Carcinoma. [2021]NAMI-A, imidazolium trans-imidazoledimethylsulfoxidetetrachlororuthenate, is a ruthenium based compounds capable of inhibiting the growth of lung metastases of solid tumours in a number of experimental conditions.The aim of this study was to investigate the potential use of NAMI-A by the oral route to treat lung metastases of MCa mammary carcinoma in the CBA mouse. treatment of mice, carrying intramuscular tumours in advanced stage of growth, for 11 consecutive days caused a significant reduction of the weight of lung metastases over the range of doses from 150 to 600 mg/kg/day. No sign of toxicity was observed at the histological analysis in the gut epithelium or in the kidney parenchyma, and NAMI-A concentration in the kidney was more than 10-fold lower than after intraperitoneal treatments. NAMI-A is thus active against metastases also by the oral route, suggesting the use of this way to treat tumour bearing hosts for long periods.