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    Summary
    EudraCT Number:2009-014591-21
    Sponsor's Protocol Code Number:H8K-MC-JZAO
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-11-13
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2009-014591-21
    A.3Full title of the trial
    A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma
    A.4.1Sponsor's protocol code numberH8K-MC-JZAO
    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 SponsorEli Lilly and Company
    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 nametasisulam sodium
    D.3.2Product code LY573636
    D.3.4Pharmaceutical form Powder for solution for infusion
    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.3.8INN - Proposed INNtasisulam sodium
    D.3.9.1CAS number 519055-63-1
    D.3.9.2Current sponsor codeLY573636
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Paclitaxel
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    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.3.8INN - Proposed INNpaclitaxel
    D.3.9.1CAS number 33069-62-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 No
    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
    Metastatic melanoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the overall survival (OS) of patients
    who have received one prior regimen of dacarbazine or temozolomide-based chemotherapy for metastatic malignant melanoma when treated with either tasisulam or paclitaxel.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    - to compare the following between treatment arms:
    • time-to-event efficacy variables, including: PFS, duration of response (DoR), deterioration in the FACT-M TOI score
    • objective tumor response rate
    • therapeutic benefit rate
    • measures of relative safety, including quantitative & qualitative laboratory &
    non-laboratory toxicities
    • health outcome measures
    - Translational Research (TR):
    • to evaluate the treatment-specific and treatment-independent effects of BRAF and
    c-Kit mutational status on measures of clinical efficacy,
    • to evaluate the treatment-specific effects of genetic markers, including on measures of clinical efficacy & toxicity.
    • to assess other exploratory biomarkers relevant to tasisulam and paclitaxel
    • to assess other exploratory biomarkers relevant to the disease state of melanoma
    • to assess the association between other exploratory biomarkers & clinical
    outcome.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Have a histologic and/or cytologic diagnosis of metastatic melanoma
    (Stage IV).
    [2] Have the presence of evaluable disease as defined by the Response
    Evaluation Criteria in Solid Tumors (RECIST version1.0).
    [3] Are at least 18 years of age.
    [4] Have a performance status of 0 to 1 on the Eastern Cooperative
    Oncology Group (ECOG) Scale (see Attachment JZAO.4).
    [5] Have progressed after 1 previous systemic treatment regimen
    containing dacarbazine or temozolomide for metastatic melanoma.
    [6] Have discontinued all previous therapies for cancer, including
    chemotherapy, radiotherapy, immunotherapy, or other investigational
    therapy for at least 30 days (45 days for mitomycin-C or nitrosoureas)
    before study enrollment and recovered from the acute effects of
    therapy (except alopecia). Whole-brain radiation must have been
    completed 90 days before starting study therapy.
    [7] Have adequate organ function including:
    • Bone Marrow Reserve: Absolute neutrophil count (ANC)
    ≥ 1.5 x 109/L prior to treatment, platelets ≥ 100 x 109/L, and
    hemoglobin ≥ 8 g/dL (transfusions are not allowed to reach 8 g/dL
    prior to enrollment).
    • Hepatic: Bilirubin ≤ 1.5 times the upper limit of normal (ULN).
    Alkaline phosphatase and transaminases (ALT and AST) ≤5 times
    ULN.
    • Renal: Serum creatinine at or below the ULN. No known active
    renal disease.
    [8] Have a serum albumin level ≥ 3.0 g/dL or ≥ 30 g/L.
    [9] Males and females with reproductive potential should use medically
    approved contraceptive precautions during the trial and for 6 months
    following the last dose of study drug.
    [10] Females with child-bearing potential must have had a negative serum
    pregnancy test ≤ 7 days prior to the first dose of study drug.
    E.4Principal exclusion criteria
    14] Are currently enrolled in, or discontinued within the last 30 days from,
    a clinical trial involving an off-label use of an investigational drug or
    device (other than the study drug used in this study), or concurrently
    enrolled in any other type of medical research judged not to be
    scientifically or medically compatible with this study.
    [15] Have received ≥ 2 previous chemotherapy-containing systemic
    treatment regimens for metastatic melanoma. An immunotherapy or
    antibody-based regimen [including biologic agents and vaccinationbased
    treatments], or treatment with a targeted agent (e.g BRAF or c-
    Kit inhibitor, is not counted as a prior treatment regimen for
    determining study eligibility, unless either was combined with a
    cytotoxic drug).
    [16] Any previous treatment with paclitaxel or a paclitaxel-containing
    regimen for metastatic melanoma.
    [17] Have active central nervous system (CNS) or leptomeningeal
    metastasis (brain metastasis) at the time of study entry.
    Patients with a history of a CNS metastasis previously treated with curative intent (e.g., stereotactic radiation or surgery) that have not progressed on
    follow-up imaging, and are not receiving corticosteroids, are eligible.
    Patients with signs or symptoms of neurological compromise should
    have appropriate radiographic imaging performed before study entry to
    rule out brain metastasis.
    [18] Have serious concomitant disorders, including active bacterial, fungal,
    or viral infection, incompatible with the study (at the discretion of the
    investigator).
    [19] Have a second primary malignancy that could affect compliance with
    the protocol or interpretation of the results. NOTE: Patients with
    adequately treated carcinoma of the skin (non-melanoma) and patients
    with a prior history of malignancy who have been disease-free for
    more than 2 years are eligible.
    [20] Have serious preexisting medical conditions (at the investigator’s
    discretion). Patients with a history of myocardial infarction within 6
    months or a history of New York Heart Association Class III or greater
    heart disease are not eligible.
    [21] Are receiving warfarin.
    [22] Have previously completed or withdrawn from this study or any other
    study investigating tasisulam.
    [23] Have a known hypersensitivity to paclitaxel or Cremophor® EL
    (polyoxyethylated castor oil).
    [24] Are pregnant or lactating.
    [25] Have primary ocular or mucosal melanoma.
    Patients with melanoma of an unknown primary site are eligible if an appropriate work-up has been performed to rule out an ocular or mucosal primary.
    [26] Have received a recent (within 30 days before enrollment) or are
    receiving concurrent yellow fever vaccination.
    [27] Have known positive test results in human immunodeficiency virus
    (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies
    (HCAb).
    (28) Are unable to withhold dosing of NSAIDs or PPIs for at least 72 hours
    before and after treatment with tasisulam.
    E.5 End points
    E.5.1Primary end point(s)
    overall survival
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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 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
    Is provided in the protocol.
    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 months8
    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 months8
    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.1.3Elderly (>=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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 800
    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)
    Is provided in the protocol.
    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 Decision2010-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-02-10
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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