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.
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 patient experiences PD or unacceptable drug-related intolerability. Patients will return for a follow-up visit 28 days after completion of the last dose of study drug, and survival data will be obtained for all randomized patients who consent to long-term follow-up. Patients who discontinue dosing and consent to follow-up will be followed indefinitely for survival status. Once the requisite number of events has been observed and the blind is broken for analysis of the trial results, any surviving patients who remain on blinded drug will be offered the opportunity to continue dosing with OL namodenoson 25 mg twice daily indefinitely.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
471
Adenosine A3 Receptor (A3AR) agonist
Control arm
Overall Survival (OS)
Median duration of survival
Time frame: From the time of randomization until the date of death from any cause, assessed up to 60 months
Progression-Free Survival (PFS)
Median time to disease progression using RECIST and modified RECIST criteria
Time frame: From the time of randomization until the date of disease progression or death from any cause, assessed up to 60 months
Objective Response Rate (ORR)
Proportion of patients who experience Objective Response (OR) using RECIST and modified RECIST criteria
Time frame: Through study completion, with a median of 9 months
Incidence and nature of treatment-emergent adverse events
Incidence and nature of treatment-emergent adverse events as assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5)
Time frame: Through study completion, with a median of 9 months
Pharmacokinetics (PK) of namodenoson in this population
Plasma concentration of namodenoson
Time frame: 29 days
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