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    Summary
    EudraCT Number:2007-002700-18
    Sponsor's Protocol Code Number:NE-180-201
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-07-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-002700-18
    A.3Full title of the trial
    An Open-Label, Sequential, Ascending dose study, to Evaluate the safety, Pharmacokinetics, and Dose Response, of fixed, Repeated Doses of NE-180 (GlycoPEGylated™rHuEPO) in Anemic Cancer Patients Receiving Chemotherapy.
    A.4.1Sponsor's protocol code numberNE-180-201
    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 SponsorNeose Technologies, Inc.
    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 nameNE-180
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNE-180
    D.3.9.3Other descriptive nameRecombinant human erythropoietin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Anaemic cancer patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064013
    E.1.2Term Cancer anaemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and tolerability of NE-180 when given every three weeks by subcutaneous injection to anaemic cancer patients receiving platin-based chemotherapy
    E.2.2Secondary objectives of the trial
    To determine the following in anaemic cancer patients with solid or non-myeloid malignancy on platin-based chemotherapy:
    1) proportion of patients on given dose of NE-180 whose haemoglobin increases ≥ 1.0 g/dL compared to baseline during the 12 week treatment phase in the absence of a red blood cell transfusion
    2) dose of NE-180 that increases and maintains the haemoglobin in the target range of 11 -12 g/dL
    3) change from baseline in haemoglobin at different doses of NE-180 at weeks 4 and 12
    4) Dose of NE-180 that is associated with haemoglobin increase of ≥ 1.0g/dL by week 12 in ≥ 50% of patients
    5) proprotion of patients treated with various doses of NE-180 who require a RBC transfusion for the treatment of anaemia
    6)the pharmacokinetic profiles of fixed SC doses of NE-180 administered every three weeks with chemotherapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female patients must be ≥ 18 and ≤ 80 years of age at the time of consent
    2.Patients must have a body weight ≥ 40 and ≤ 90 kgs
    3.Patients must have a diagnosis of histologically-confirmed solid tumor or non-myeloid malignancy
    4.Patients must be on a 4-6 cycle regimen of myelosuppressive chemotherapy (platin or non-platin-based chemotherapy is permitted) with a dosing schedule of every three weeks. Upon enrollment to the treatment phase (week 0), patients are expected to receive at least 4 additional cycles of chemotherapy.
    5.Patients must have anaemia defined as baseline haemoglobin level of ≥ 9.0 and ≤ 11.0 g/dL within one week prior to administration of study drug.
    6.Patients are expected to be treated with intravenous (IV) iron throughout the treatment phase.
    7. Patients must have an Eastern Co-operative Oncology Group (ECOG) performance status of 0,1 or 2
    8.Patients must have a life expectancy of 6 months or more
    9.If female, the patient must;
    a)be postmenopausal for at least one year, or
    b)have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy, or
    c)have practiced one of the following methods of contraception for at least one month prior to study entry (screening visit): hormonal contraceptives, spermicide and barrier, intrauterine device, spousal/partner sterility, and agree to agree to use two of these described contraceptive methods throughout the study, or
    d)be practicing abstinence and agree to continue abstinence or to use two of the acceptable methods of contraception (as listed above) should sexual activity commence.
    e)have a negative serum pregnancy test at time of screening.

    10. After full explanation of the study, patients must understand the nature of the study and have signed the informed consent to participate
    E.4Principal exclusion criteria
    1.Patients who received treatment with erythropoietic stimulating agents (ESA) within the last 90 days
    2.Patients with known antibodies to other ESAs or history of Pure Red Cell Asplasia
    3.Patients who received two or more RBC transfusions within 4 weeks of screening or any RBC transfusion within 14 days of screening
    4.Patients with iron deficiency defined as baseline TSAT <20%
    5.Patients with baseline serum creatinine > 2.0 mg/dL
    6.Patients with baseline ALT or AST > 2.5 times the upper limit of normal, or ALT or AST > 5 times the upper limit of normal if liver metastases are present
    7.Patients who have a history of poorly controlled hypertension per the investigator’s judgement within 4 weeks prior to screening
    8.Patients with a history of pulmonary embolism or deep vein thrombosis within the previous two years or currently on therapeutic doses of anticoagulants
    9.Patients with active cardiac disease as defined by a history of myocardial infarction, peripheral ischemia requiring angioplasty or surgery, mesenteric ischemia , or stroke within 6 months prior to screening
    10.Patients with a history of congestive heart failure (NYHA class III or IV)
    11.Known history or current diagnosis of anaemia attributed to a haematologic disorder or other etiology other than the current malignancy or chemotherapy treatment.
    12.Patients with active infection, or any chronic inflammatory disorder
    13.Patients with a history of seizure disorder
    14.Patients who have participated in an investigational study within 30 days of the anticipated first dose of the study drug, or are planning participation during the study period
    15.Patients with a known positive test for HIV and patients who are know to be hepatitis B or C carrriers
    16.Patients who have a known allergy or hypersensitivity to the study drug and/or any of its components
    17.Patient is pregnant or lactating
    18.Patient is taking a drug/s not approved by the appropriate regulatory authority
    19.Other factors which may affect participation, such as mental or legal incapacitation, drug or alcohol abuse within the last 2 years, or, in the investigator’s opinion, patients who may not be capable of following the study’s schedule for any reason.
    E.5 End points
    E.5.1Primary end point(s)
    1) Proportion of patients on a given dose of NE-180 who achieved a haemoglobin response
    2) Proportion of patients on a given dose of NE-180 where the haemoglobin increased and was maintained at the target range of 11-13 g/dL in the absence of RBC transfusions
    3) change from baseline in haemoglobin at weeks 4 and 12
    4) incidence of patients receiving RCB transfusions during weeks 5-12
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 45
    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 Decision2007-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-11
    P. End of Trial
    P.End of Trial StatusOngoing
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