Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis

Part of paid clinical trials in Dallas, Texas.

Sponsor
Can-Fite BioPharma
Study ID
NCT05201404
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Namodenoson — DRUG
    Adenosine A3 Receptor (A3AR) agonist
  • Placebo — DRUG
    Control arm

Study Details

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.

Key Dates

Start date
Mar 15, 2023
Status verified
Apr 2025
Primary completion
Feb 28, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
471 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Namodenoson (CF102)
    Namodenoson 25 mg orally BID, until disease progression or unacceptable adverse events
  • Placebo Comparator: Placebo
    Matching placebo orally BID, until disease progression or unacceptable adverse events

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From the time of randomization until the date of death from any cause, assessed up to 60 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Site 881DallasTexas75201
Study Coordinator

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