Namodenoson for Liver Cancer
(LIVERATION Trial)
Trial Summary
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.
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.
12345Eligibility 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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral doses of either namodenoson 25 mg or matching placebo twice daily for consecutive 28-day cycles
Follow-up
Participants return for a follow-up visit 28 days after the last dose of study drug, and survival data is collected
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
Participant Groups
Namodenoson is already approved in European Union, United States for the following indications:
- None (currently in Phase III trials for hepatocellular carcinoma)
- None (currently in Phase III trials for hepatocellular carcinoma)