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

ConditionsHepatocellular Carcinoma Cirrhosis

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorCan-Fite BioPharma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females at least 18 years of age.

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.

Disqualifiers

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 the trial.

Locoregional treatment within 4 weeks prior to the Baseline Visit.

Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.

Trial design

Design model

Parallel

Treatments tested in this trial

Namodenoson
Drug
Adenosine A3 Receptor (A3AR) agonist
Placebo
Drug
Control arm

Treatment groups

471 Participants

are divided into 2 treatment groups

Group A: Namodenoson (CF102)Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

Duration Of Response (DOR)

Time from first response (CR or PR) to progression or death, whichever occurs first

Time frame

Through study completion, with median of 9 months

Disease Control Rate (DCR)

Proportion of patients who experience OR as well as those who experience Stable Disease (SD) for at least four treatment cycles, ie, four months

Time frame

Through study completion, with median of 9 months

Quality of Life (QOL) using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)

Assess QOL in this population using the EORTC QLQ-C30, a 30-item questionnaire. Each question is measured in a range in score from 0 to 100. A high scale score represents a higher response level.

Time frame

Through study completion, with a median of 9 months

Quality of Life (QOL), using the hepatocellular carcinoma- (HCC-) specific module of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-question Module (EORTC QLQ-HCC18)

Assess QOL in this population using the HCC-specific module of the EORTC QLQ-HCC18, an 18-item questionnaire. Each question is measured in a range in score from 0 to 100. A high scale score represents a higher response level.

Time frame

Through study completion, with a median of 9 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Can-Fite BioPharma

Lead sponsor

Source ClinicalTrials.gov

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