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    Summary
    EudraCT Number:2021-005286-41
    Sponsor's Protocol Code Number:CF102-301HCC
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-03-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-005286-41
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial in patients with Advanced Hepatocellular Carcinoma and Child Pugh Class B7 cirrhosis.
    A.4.1Sponsor's protocol code numberCF102-301HCC
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05201404
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCanFite BioPharma Ltd.
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCanFite BioPharma Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCanFite BioPharma Ltd.
    B.5.2Functional name of contact pointStudy Director
    B.5.3 Address:
    B.5.3.1Street Address10 Bareket Street, Kiryat Matalon
    B.5.3.2Town/ cityPetach Tikva
    B.5.3.3Post code49170
    B.5.3.4CountryIsrael
    B.5.4Telephone number0097239241114
    B.5.5Fax number0097239249378
    B.5.6E-mailzivit@canfite.co.il
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCF102
    D.3.2Product code CF102
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN2-Chloro-N6-(3-iodobenzyl)adenosine-5’-N-methyluronamide
    D.3.9.1CAS number 163042-96-4
    D.3.9.2Current sponsor codeCF102
    D.3.9.3Other descriptive nameCl-IB-MECA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced Hepatocellular Carcinoma in Patients with Child-Pugh Class B7 Cirrhosis
    E.1.1.1Medical condition in easily understood language
    Liver cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073071
    E.1.2Term Hepatocellular carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of orally administered namodenoson 25 mg twice daily as compared to placebo, as determined by Overall Survival (OS), in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B7 (CPB7) cirrhosis.
    E.2.2Secondary objectives of the trial
    • Evaluate other indicators of efficacy of namodenoson as compared to placebo, as indicated by progression free survival (PFS) and objective response rate (ORR), using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Eisenhauer 2009) and RECIST as modified for HCC (mRECIST) (Lencioni 2010);
    • Characterize the safety profile of namodenoson in patients with advanced HCC and CPB7 cirrhosis; and
    • Further define the pharmacokinetics (PK) of namodenoson in the CPB7 population.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PK/Pharmacodynamics (PD)
    Explore exposure-response relationships using sparse PK sampling

    Blood samples will be collected from all patients enrolled as sites with the requisite technical capabilities during Cycle 1 on Days 1, 8 and 15 and on Day 1 of Cycle 2 to determine plasma concentrations of namodenoson.
    E.3Principal inclusion criteria
    Inclusion Criteria for Double-Blind Portion of the Trial
    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) (Appendix E).
    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 than 2, prior systemic treatment regimens; prior locoregional therapy is allowed.
    5. Barcelona Clinic Liver Cancer (BCLC) Stage B or C (Llovet 1999).
    6. Prior HCC treatment was discontinued for at least 2 weeks prior to the Baseline Visit.
    7. Measurable disease by RECIST v1.1 (Eisenhauer 2009).
    8. ECOG PS of ≤ 1.
    9. Cirrhosis classified as CPB7 (Appendix C); 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, Appendix F).
    10. The following laboratory values must be documented prior to the first dose of study drug:
    • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
    • Platelet count ≥ 75 × 109/L
    • Creatinine clearance ≥50 mL/min (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.
    11. Life expectancy of ≥ 6 weeks.
    12. For women of childbearing potential, negative serum pregnancy test result.
    13. Provide written informed consent to participate.
    14. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other trial-related procedures.

    Eligibility Criteria for Open-Label Portion
    1. The patient signed the Informed Consent Form (ICF) for the OL treatment portion.
    2. The patient received double-blind treatment with namodenoson/placebo and is still taking the study medication at the time of completion of the double-blind portion for analysis.
    E.4Principal exclusion criteria
    1. Receipt of >2 prior systemic drug therapies for HCC.
    2. 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.
    3. Locoregional treatment within 4 weeks prior to the Baseline Visit.
    4. Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.
    5. Use of any investigational agent within 4 weeks prior to the Baseline Visit.
    6. 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 the investigational product (see Section 12.2).
    7. Child-Pugh Class A, B8/9, or C cirrhosis.
    8. Hepatic encephalopathy.
    9. Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit.
    10. Uncontrolled or clinically unstable thyroid disease, per judgment of the Principal Investigator.
    11. Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention, with the exception of active viral hepatitis B or C, which may be treated per Investigator judgment.
    12. Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
    13. Liver transplant.
    14. Active malignancy other than HCC.
    15. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4) (Appendix B).
    16. 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.
    17. 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 be excluded for QTc reasons).
    18. Pregnant or lactating female.
    19. Women of childbearing potential, unless they agree to use an acceptable contraceptive method as described in Section 12.3 while on study and until 1 month after the last dose of study medication.
    20. Men who partner with a woman of childbearing potential, unless they agree to use a condom for contraception from Screening until 1 month after the last dose of study medication.
    21. 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 consent process and/or with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator’s opinion, would make the patient inappropriate for entry into this trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be OS, defined as the number of days from randomization to death due to any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Survival status will be assessed continuously
    E.5.2Secondary end point(s)
    Key secondary endpoints to be evaluated are PFS and ORR, where ORR consists of patients who experience Complete Response (CR) or Partial Response (PR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor status will be assessed at the Pre-Study Visit and every eight weeks thereafter (i.e., at the end of even numbered cycles) by computed tomography (CT) scan or magnetic resonance imaging (MRI) scan according to RECIST and mRECIST.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bosnia and Herzegovina
    Moldova, Republic of
    Israel
    Serbia
    Bulgaria
    Poland
    Romania
    Slovakia
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 171
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 471
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    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 for no longer than 1 year after the final analysis.

    After completion of participation in the study, the patient will be provided with standard care, as recommended by the treating physician.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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