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    Summary
    EudraCT Number:2014-000489-23
    Sponsor's Protocol Code Number:CF102-201HCC
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-03
    Trial results View 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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2014-000489-23
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of CF102 in the Second-Line Treatment of Advanced Hepatocellular Carcinoma in Subjects with Child-Pugh Class B Cirrhosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial in subjects with advanced Hepatocellular Carcinoma and Child Pugh B cirrhosis
    A.4.1Sponsor's protocol code numberCF102-201HCC
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02128958
    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 SponsorCan-Fite 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 supportCan-Fite BioPharma Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCan-Fite BioPharma Ltd.
    B.5.2Functional name of contact pointStudy Director
    B.5.3 Address:
    B.5.3.1Street Address10 Bareket St. Kiryat Matalpon PO Box 7537
    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-mailsari@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, hard
    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 number1
    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, hard
    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
    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 19.0
    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 CF102 25 mg twice daily (BID) as compared to placebo, as determined by Overall Survival (OS), when used as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B (CPB) cirrhosis
    E.2.2Secondary objectives of the trial
    - Evaluate other indicators of efficacy of CF102 as compared to placebo, including time to progression (TTP), progression-free survival (PFS), objective response (OR) rate, and disease control (DC) rate in this population;
    - Explore exposure-response relationships using sparse pharmacokinetic (PK) sampling;
    - Characterize the safety profile of CF102 in subjects with advanced HCC and CPB cirrhosis;
    - Characterize the effects of CF102 on laboratory parameters associated with viral hepatitis, hepatic dysfunction, and cirrhosis; and
    - Explore the relationship between peripheral blood mononuclear cell (WBC) adenosine A3 receptor (A3AR) expression and clinical response
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetics in selected sites, included in study Protocol Am. 1 dated 16 June 2014
    E.3Principal inclusion criteria
    1. Males and females at least 18 years of age.
    2. Diagnosis of HCC:
    • For subjects without underlying cirrhosis at the time of diagnosis, diagnosis of HCC documented by cytology and/or histology.
    • For subjects 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 (Appendix E).
    3. HCC is advanced, ie, treatment-refractory or metastatic, and no standard therapies are expected to be curative.
    4. Receipt of prior sorafenib therapy for at least 3 weeks and withdrawal from treatment due either to intolerability or to radiographic evidence of disease progression. If treatment was withdrawn due to intolerability manifested as a Grade 3 or 4 event by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE v4.0), less than 3 weeks of continuous prior administration prior to withdrawal is acceptable (see also Exclusion Criterion #3).
    5. Prior sorafenib treatment was discontinued for at least 2 weeks prior to the Baseline Visit.
    6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2 (Appendix B).
    7. Cirrhosis classified as Child-Pugh Class B (Appendix C).
    8. The following laboratory values must be documented within 3 days prior to the first dose of study drug:
    • Absolute neutrophil count (ANC)  1.5 × 109/L
    • Platelet count  75 × 109/L
    • Serum creatinine  2.0 mg/dL
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × the upper limit of normal (ULN)
    • Total bilirubin ≤ 3.0 mg/dL
    • Serum albumin ≥ 2.8 g/dL
    • Prothrombin time (PT) no greater than 6 seconds longer than control.
    9. Life expectancy of ≥ 6 weeks.
    10. For women of childbearing potential, negative serum pregnancy test result.
    11. Provide written informed consent to participate.
    12. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other trial related procedures.
    E.4Principal exclusion criteria
    1. Receipt of no, or of > 1, 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. Presence of an acute or chronic toxicity of prior chemotherapy that has not resolved to ≤ Grade 1, as determined by CTCAE v 4.0.
    4. Locoregional treatment within 4 weeks prior to the Baseline Visit.
    5. Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.
    6. Use of any investigational agent within 4 weeks prior to the Baseline Visit.
    7. Child-Pugh Class A or C cirrhosis, or hepatic encephalopathy.
    8. Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit.
    9. Uncontrolled or clinically unstable thyroid disease, per judgement of the Principal Investigator.
    10. Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
    11. Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
    12. Liver transplant.
    13. Active malignancy other than HCC.
    14. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4) (Appendix B).
    15. 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.
    16. History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to > 450 msec for males or > 470 msec for females.
    17. Pregnant or lactating female.
    18. Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Investigator, are effective and adequate for the subject’s circumstances while on study drug.
    19. Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (ie, a condom, with female partner using oral, injectable, or barrier method) while on study drug and for 3 months afterward.
    20. 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 subject inappropriate for entry into this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival, defined as the number of days from first dose 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)
    Time To Progression, Progression -free Survival, Overall Response rate (consisting of Complete Response (CR) or Partial Response (PR) in subjects who enter with measurable disease by RECIST v1.1), and Disease Control rate which includes subjects with Overall Response as well as those with Stable Disease (SD)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor status will be assessed at baseline and every 8 weeks thereafter (i.e., at the end of even-numbered cycles) by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST v1.1 criteria as modified by Santoro [2013].
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Bulgaria
    Israel
    Romania
    Serbia
    United States
    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
    The post-accrual treatment period will continue until a total of 75 subjects have died
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 39
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 39
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 78
    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)
    None
    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 Decision2014-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
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