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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-013778-41
    Sponsor's Protocol Code Number:C18770/2043
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-13
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-013778-41
    A.3Full title of the trial
    An Open-Label Study to Determine the Maximum Tolerated Dose and Evaluate the Efficacy and Safety of CEP-18770 in Patients With Relapsed Multiple Myeloma Refractory to the Most Recent Therapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study that involves patients with a plasma cell cancer in the bone marrow. The study will determine the best dosing level with tolerable side effects of a new pharmaceutical compound with code CEP18770. The participating patients have had therapy but the disease came back and is now difficult to treat.
    A.4.1Sponsor's protocol code numberC18770/2043
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01023880
    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 SponsorCephalon, 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 supportCephalon Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD Clinical
    B.5.2Functional name of contact pointErik Peterson
    B.5.3 Address:
    B.5.3.1Street Address929 North Front Street
    B.5.3.2Town/ cityWilmington, NC
    B.5.3.3Post code28401-3331
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1919558 3026
    B.5.5Fax number+1919654 0752
    B.5.6E-mailErik.Peterson@ppdi.com
    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.3.2Product code CEP-18770
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 847499-27-8
    D.3.9.2Current sponsor codeCEP-18770
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with relapsed multiple myeloma refractory to the most recent therapy.
    E.1.1.1Medical condition in easily understood language
    Patients with plasma cell cancer in the bone marrow.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10028229
    E.1.2Term Multiple myelomas
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective
    part 1 : to determine the maximum tolerated dose of CEP-18770
    part 2 : to evaluate the antitumor activity of CEP-18770 in patients treated at the MTD (2.1 mg/m2) including patients treated at the MTD (2.1 mg/m2) in part 1. The antitumor activity will be assessed by overall response rate (ORR) including stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to the International Myeloma Working Group criteria.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are as follows:
    • to evaluate the durability of response as determined by duration of response (DOR) to CEP 18770 (part 2 and patients treated at MTD [2.1 mg/m2] in part 1)
    • to determine the time to response (TTR) to CEP 18770 (part 2 and patients treated at MTD [2.1 mg/m2] in part 1)
    • to assess the time to progression (TTP) with CEP 18770 (part 2 and patients treated at MTD [2.1 mg/m2] in part 1)
    • to further characterize the pharmacokinetics of CEP 18770 administered on days 1, 8, and 15 of a 28 day cycle
    • to assess the exposure/response relationship of CEP-18770 and to assess whether there is a relationship between systemic exposure and relevant safety parameters
    • to evaluate proteasome inhibition by CEP 18770
    • to evaluate the safety of treatment with CEP 18770 administered intravenously on days 1, 8, and 15 of a 28 day cycle to patients with relapsed and refractory multiple myeloma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a- The patient has relapsed multiple myeloma that has progressed following therapies that included bortezomib and an IMiD (thalidomide or lenalidomide) either alone or in any combination.
    b-The patient has multiple myeloma, which is refractory (ie, disease progression during or within 90 days of completing treatment) to the most recent therapy, bortezomib or IMiD, or any other chemotherapy, OR the patient did not tolerate and discontinued the most recent therapy for multiple myeloma but has recovered from its toxic effects.
    c-The patient has measurable disease defined as 1 of the following:•serum M-protein ≥ 0.5 g/dL•urine M-protein ≥200 mg/24 hours.
    d-Written informed consent is obtained.
    e-The patient is a man or woman at least 18 years of age.
    f-The patient has a life expectancy of more than 3 months.
    g-The patient has an ECOG performance status of 0, 1, or 2.
    h-The patient has adequate hepatic organ function (<2.0 times the upper limit of normal [ULN] for total bilirubin, and <2.5 times ULN for [AST] and [ALT]).
    i-The patient has an absolute neutrophil count (ANC) greater than 1 x 109/L, hemoglobin greater than 8.0 g/dL, and platelet count greater than 50 x 109/L.
    j-The patient has been independent of granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) support for more than 1 week.
    k-The patient has been independent of platelet transfusion for more than 1 week.
    l-The patient may have received an allogeneic and/or autologous transplant.
    m-The patient has a creatinine clearance of 30 mL/minute or more as measured or as calculated based on the Cockcroft Gault method.
    n-Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 3 months after participation in the study. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
    o-The patient, if a man, is surgically sterile, or if sexually active with a woman of childbearing potential (as defined in criteria m above), is currently using an effective barrier method of contraception, and agrees to continue use of this method for the duration of the study and for 3 months after the last administration of study drug.
    p-The patient must be willing and able to receive outpatient treatment and laboratory monitoring at the study center where study drug is administered.
    E.4Principal exclusion criteria
    a-The patient has nonmeasurable multiple myeloma, defined as less than 0.5 g/dL M-protein in serum and less than 200 mg/24 hours M-protein in urine.
    b-The patient received glucocorticoid therapy (prednisone >10 mg/day orally or equivalent) within the last 2 weeks prior to the first dose of study drug.
    c-The patient has POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy or monoclonal proliferative disorder, and skin changes [increased skin pigment, increased body hair, thickening of the skin, whitening of the nails, etc]).
    d-The patient has plasma cell leukemia.
    e1-The patient received chemotherapy with approved or investigative anticancer therapeutics within 2 weeks or within 5 drug half-lives (t1/2) or investigative anticancer therapeutics within 4 weeks or within 5 drug half-lives (t1/2) before the first dose of study drug, whichever time is greater
    f-The patient received radiation therapy or immunotherapy in the 4 weeks or localized radiation therapy within 1 week prior to the first dose of study drug.
    g-The patient received prior treatment with CEP 18770.
    h-The patient has used a medication known to be a potent inducer of CYP2E1, CYP2D6 or CYP3A4/5 within 4 weeks prior to the first dose of study drug.
    i-The patient has used a medication known to be a potent inhibitor of CYP2E1, CYP2D6 or CYP3A4/5 within 2 weeks prior to the first dose of study drug.
    j-The patient had major surgery within 3 weeks before the first dose of study drug.
    k-The patient has congestive heart failure (New York Heart Association Class III to IV) or had symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within the last 6 months.
    l-The patient had an acute infection requiring systemic antibiotics, antiviral agents, or antifungal agents within 2 weeks before the first dose of study drug.
    m-The patient has a known or suspected human immunodeficiency virus (HIV) infection on the basis of medical history.
    n-The patient had a nonhematologic malignancy within the past 3 years except for the following: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or prostate cancer (Gleason grade <6 with prostate specific antigen levels within the normal range).
    o-The patient has myelodysplastic or myeloproliferative syndrome.
    p-The patient has significant neuropathy (grade 3 or 4 or grade 2 with pain).
    q-The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
    r-The patient has known central nervous system (CNS) involvement.
    s-The patient has any serious psychiatric or medical condition that could interfere with treatment or study procedures, place the patient at unacceptable risk, or confound the ability of investigators to interpret study data.
    t-The patient has known hypersensitivity to mannitol or hydroxypropyl betadex.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure is the patient’s best response to treatment with CEP 18770 during part 2 of the study (including patients treated at the MTD [2.1 mg/m2] in part 1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    E.5.2Secondary end point(s)
    The secondary efficacy measures and endpoints for this study are as follows:
    • the time from the date that criteria for response (sCR, CR, VGPR, or PR) to treatment with CEP 18770 are first met to the date of disease progression (duration of response [DOR])
    • the time from the date of first dose of CEP 18770 to the date of first response (TTR) to treatment with CEP 18770
    • the time from the date of first dose of CEP 18770 to the date of disease progression (TTP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 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 No
    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) No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Belgium
    France
    Spain
    United States
    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
    Every patient will have an end of treatment visit 30 to 44 days after their last dose of study drug.
    The study will end when every patient has experienced disease progression, died, or been monitored for approximately 1 year after their first administration of CEP 18770.
    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 months5
    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 months5
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 66
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 86
    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)
    Standard of Care
    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 Decision2010-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-15
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