BridgeMD
New treatment option for Hepatocellular Carcinoma
Official title Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
ClinicalTrials.gov ID: NCT05201404
What this study is testing
What is Namodenoson?
Namodenoson is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as CF102.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- HCC is advanced (i.e., treatment-refractory or metastatic) and no standard therapies are expected to be curative.
You likely can't join 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...
- 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...
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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).
- Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
- History of, or ongoing, cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to \> 470 msec (patients with bundle branch block will not...
- Pregnant or lactating female.
- Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Investigator, are effective and adequate for the patient's circumstances while on study drug.
- Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable, or barrier method) while on study drug...
- Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed...
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
- Banja Luka, Bosnia and Herzegovina
- Mostar, Bosnia and Herzegovina
- Sarajevo, Bosnia and Herzegovina
- Burgas, Bulgaria
- Plovdiv, Bulgaria
- Sofia, Bulgaria
- Petah Tikva, Israel
- Chisinau, Moldova
- Koszalin, Poland
- Krakow, Poland
- Mysłowice, Poland
- Przemyśl, Poland
- Warsaw, Poland
- Wroclaw, Poland
- Cluj-Napoca, Romania
- Constanța, Romania
- Craiova, Romania
- Iași, Romania
- Oradea, Romania
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States; Banja Luka, Bosnia and Herzegovina; Mostar, Bosnia and Herzegovina; Sarajevo, Bosnia and Herzegovina; Burgas, Bulgaria; Plovdiv, Bulgaria and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.