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    Summary
    EudraCT Number:2007-004795-39
    Sponsor's Protocol Code Number:LSO-OL005
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-004795-39
    A.3Full title of the trial
    A PHASE 3 RANDOMIZED STUDY TO EVALUATE SURVIVAL OF PATIENTS TREATED WITH TALAPORFIN SODIUM (LS11) AND INTERSTITIAL LIGHT EMITTING DIODES (LED) AS COMPARED TO THE STANDARD OF CARE THERAPIES IN THE TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberLSO-OL005
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLIGHT SCIENCES ONCOLOGY
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameTalaporfin Sodium
    D.3.2Product code Litx
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLS11
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatocellular carcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10019695
    E.1.2Term Hepatic neoplasm
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the survival of patients treated with Litx™ versus standard of care
    therapies in the treatment of unresectable hepatocellular carcinoma (HCC).
    Demonstrate the safety of Litx™ therapy.
    E.2.2Secondary objectives of the trial
    Assess the survival of a subset of patients in the Litx™ group who
    received Litx™ treatment followed by the standard of care versus patients
    in the standard of care group for the treatment of unresectable
    hepatocellular carcinoma (HCC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A diagnosis of primary Hepatocellular Carcinoma (HCC),
    established by any one of the following criteria in a clinical setting
    suggestive of HCC:
    A. Two different imaging techniques with characteristics that
    suggest HCC
    B. Combination of one imaging technique that suggests HCC and
    serum AFP level >400 ng/mL
    C. Histological evidence of HCC
    2. Patients who are candidates for surgery with curative intent are not
    eligible
    3. Patients with 6 or more lesions are not eligible
    4. Patients with greater than 50% of parenchyma disease involvement
    are excluded
    5. Patients with Child-Pugh C cirrhosis are excluded
    6. Patients with diffuse HCC are excluded
    7. Patients with grade 3 ascites are excluded
    8. Evidence of major vessel invasion or extrahepatic disease is
    excluded. Lymph node involvement in the hilum region of the liver
    is eligible if the nodes do not exceed 2 cm.
    9. ECOG Performance Status 0-2
    10. Life expectancy of at least 16 weeks
    11. Patients may have received previous antineoplastic therapy; at least 3
    weeks must have elapsed since the completion of any prior therapy
    and the patient must have recovered from acute side effects.
    12. Known sensitivity to porphyrin-type drugs or known history of
    porphyria are exclusionary
    13. Understanding and ability to sign written informed consent
    14. 18 years of age or more
    15. Pregnancy or breast-feeding patients are excluded. A negative
    pregnancy test (urine or serum) from women of childbearing age is
    required prior to enrollment. A fertile patient must use effective
    contraception during participation in the study
    16. Adequate hematologic, liver and renal functions as evidenced by the
    following:
    WBC > 2,400/mm3
    Platelet Count > 75,000/&#956;l
    Hemoglobin > 9.4 gm/dL
    PT and PTT < 1.5 Control
    SGOT, SGPT < 5 x ULN
    Bilirubin < 2.5 x ULN
    Alk Phos < 3 x ULN
    Creatinine < 2.5 mg/dL (SI: 221 &#956;mol/L)
    Albumin > 2 g/dL
    17. Concurrent participation in another clinical trial involving
    experimental treatment is excluded
    18. Any concurrent disease or condition that in the opinion of the
    investigator impairs the patient’s ability to complete the trial such as
    psychological, familial, sociological, geographical or medical
    conditions which in the Principal Investigator’s opinion could
    compromise compliance with the objectives and procedures of this
    protocol or obscure interpretation of the trial’s data are excluded.
    E.4Principal exclusion criteria
    17. Concurrent participation in another clinical trial involving
    experimental treatment is excluded18. Any concurrent disease or condition that in the opinion of the
    investigator impairs the patient’s ability to complete the trial such as
    psychological, familial, sociological, geographical or medical
    conditions which in the Principal Investigator’s opinion could
    compromise compliance with the objectives and procedures of this
    protocol or obscure interpretation of the trial’s data are excluded.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    Overall survival in the intent-to-treat population of patients.
    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 No
    E.6.7Pharmacodynamic No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    terapia standard
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    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
    -Il paziente decide di ritirare il consenso informato
    -decisione del medico
    -il pazienze soffre di tossicitá di grado 4
    -il paziente non segue il protocollo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-10-08. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 200
    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 Decision2008-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-25
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