A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
Can-Fite BioPharma
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.
Description
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in patients with advanced HCC and 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. Patients will be randomly assigned in a 2:1 ratio to treatment with oral doses of either namodenoson 25 mg or matching placebo administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Tumor imaging will be performed every two cycles. Treatment will continue until the patien…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males and females at least 18 years of age. 2. 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). 3. HCC is advanced (i.e., treatment-refractory or metastatic) and no standard therapies are expected to be curative. 4. HCC has progressed on at least 1, but no more…
Interventions
- DrugNamodenoson
Adenosine A3 Receptor (A3AR) agonist
- DrugPlacebo
Control arm
Locations (32)
- Site 881Dallas, Texas
- 841 University Clinical Centre of Republic of SrpskaBanja Luka
- 843 University Clinical Hospital MostarMostar
- 842 University Clinical Centre SarajevoSarajevo
- 831 Dept of Medical Oncology, Complex Oncology Ctr - Burgas EOODBurgas
- 835 First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD, PlovdivPlovdiv