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Namodenoson for Liver Cancer (LIVERATION Trial)
Phase 3
Recruiting
Research Sponsored by Can-Fite BioPharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cirrhosis classified as CPB7
HCC is advanced and no standard therapies are expected to be curative
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of randomization until the date of death from any cause, assessed up to 60 months
Awards & highlights
LIVERATION Trial Summary
This trialtests if a new drug can help people with advanced liver cancer and cirrhosis whose disease has worsened.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the side effects of Namodenoson aren't detailed here, common side effects for cancer drugs include nausea, fatigue, blood count changes, risk of infection increase, liver function changes, and possible allergic reactions.
LIVERATION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver condition is classified as moderate.
Select...
My liver cancer is advanced and cannot be cured with standard treatments.
Select...
My liver cancer is at an intermediate or advanced stage.
Select...
My liver cancer has worsened after 1 or 2 treatments.
Select...
I can carry out all my self-care activities without assistance.
Select...
I have been diagnosed with liver cancer, with or without liver cirrhosis.
LIVERATION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of randomization until the date of death from any cause, assessed up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of randomization until the date of death from any cause, assessed up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Incidence and nature of treatment-emergent adverse events
Objective Response Rate (ORR)
Pharmacokinetics (PK) of namodenoson in this population
+1 moreOther outcome measures
Disease Control Rate (DCR)
Duration Of Response (DOR)
Quality of Life (QOL) using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
+1 moreLIVERATION Trial Design
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
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Who is running the clinical trial?
Can-Fite BioPharmaLead Sponsor
18 Previous Clinical Trials
2,441 Total Patients Enrolled
Michael H Silverman, MDStudy DirectorBioStrategics Consulting Ltd
15 Previous Clinical Trials
2,208 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver condition is classified as moderate.My liver cancer is advanced and cannot be cured with standard treatments.My liver disease is classified as cirrhosis.I stopped my liver cancer treatment at least 2 weeks ago.I am 18 years old or older.My liver cancer is at an intermediate or advanced stage.My liver cancer has worsened after 1 or 2 treatments.I have had more than two treatments for liver cancer.I can carry out all my self-care activities without assistance.I have recently received specific treatments.I have been diagnosed with liver cancer, with or without liver cirrhosis.
Research Study Groups:
This trial has the following groups:- Group 1: Namodenoson (CF102)
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What have been the reported side effects of Namodenoson (CF102) when used therapeutically?
"After examining the evidence, our team scored Namodenoson (CF102) with a 3 due to its safety profile based on multiple Phase 3 trials which demonstrate efficacy and numerous rounds of data supporting its safeguard."
Answered by AI
Are individuals being sought to participate in this investigation?
"According to clinicaltrials.gov this specific medical trial is not presently enrolling patients, despite being initially posted on 1/1/2023 and last updated on 1/27/2023. Nonetheless, there are still 2,962 other clinical trials actively recruiting participants at the current moment in time."
Answered by AI
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