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    Summary
    EudraCT Number:2006-002584-70
    Sponsor's Protocol Code Number:155-CL-009
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-01
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-002584-70
    A.3Full title of the trial
    A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects
    A.4.1Sponsor's protocol code number155-CL-009
    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 SponsorAstellas Pharma US, 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 nameYM155
    D.3.2Product code YM155
    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.3.9.2Current sponsor codeYM155
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Diffuse large B-cell Lymphoma refractory
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10012822
    E.1.2Term Diffuse large B-cell lymphoma refractory
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the overall response rate (Complete Remission + Partial Remission) of YM155 per the International Working Group Criteria (IWG, 2007) during 15 cycles of treatment.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy, safety and tolerability of YM155 during 15 cycles of treatment.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    QT sub-study: included in the main study protocol. The objective of the sub-study is to assess the potential effect of YM155 on cardiac intervals including QT.

    Pharmacogenomic sub-study: included in the main study protocol. The objective of this research is to comprehensively analyze:
    • Suspected disease-related genes
    • Genes potentially involved in drug excretion and/or metabolism
    • Genes of relevance to toxicity/safety issues, to be identified in a precautionary / retrospective setting.

    Biomarker sub-study: included in the main study protocol. The objective of this research is to comprehensively analyze protein expression that may yield prognostic, predictive or mechanistic information.
    E.3Principal inclusion criteria
    - Male or female subjects aged 18 years or older.
    - Histologically confirmed primary Diffuse Large B-Cell Lymphoma (DLBCL) of any stage.
    - Refractory to the last treatment regimen, defined as one of the following:
    o The subject failed to obtain at least a Partial Response (PR) at anytime while receiving the last treatment regimen.
    o The subject obtained at least a PR during the last treatment regimen, but later progressed while still on the treatment regimen.
    o The subject obtained at least a PR to the last treatment regimen, but progressed within 6 months following completion of the last treatment regimen.
    - Subjects must have been previously treated with the following treatment regimens:
    o Anthracycline-based combination chemotherapy with rituximab
    o Second-line combination chemotherapy
    o Autologous bone marrow transplant (BMT) or autologous peripheral blood stem cell transplant (PBSCT) if eligible and did not refuse. Subjects that were not eligible for an autologous BMT or PBSCT or subjects that were eligible and refused the procedure are candidates for this trial.
    - At least one measurable lesion defined as > or equal to 1.5 cm in the longest transverse diameter by CT scan
    - No known central nervous system (CNS) involvement
    - Eastern Cooperative Oncology Group (ECOG) performance status < or equal to 2
    E.4Principal exclusion criteria
    - Transformed, discordant or composite lymphoma.
    - Any therapy for lymphoma within 21 days prior to the first YM155 dose.
    - Within 4 weeks of the baseline FDG-PET scan, subjects cannot have had the following:
    o Radiation therapy.
    o Surgical procedures (except biopsies and central catheter / port placement).
    o Active infection (bloodstream or deep tissue).
    - Inadequate marrow, hepatic and/or renal function at the Baseline Visit defined as:
    o Serum creatinine superior or equal to 1.5 x Upper Limit of Normal (ULN) or calculated serum creatinine clearance < 60 mL/min.
    o Absolute Neutrophil Count (ANC) inferior or equal to 750/mm3.
    o Platelet inferior or equal to 50,000/mm3.
    o Alanine Transaminase (ALT) and Aspartate Transaminase (AST) superior or equal to 2.5 x ULN; superior or equal to 5 x ULN if secondary to liver metastases.
    - Subjects received > 3 prior treatment regimens for their lymphoma. The following should be considered when determining the number of prior treatment regimens:
    o Any planned maintenance therapy should be considered as part of the previous treatment regimen
    o Any preparative treatment (salvage chemotherapy, high-dose chemotherapy, radiation therapy, etc.) should be included with the autologous BMT or autologous PBSCT as one treatment regimen.
    - Allogeneic BMT or allogeneic PBSCT.
    - History of other malignancy requiring treatment within 2 years prior to the first dose of YM155, except for treated basal or squamous cell carcinoma of the skin or in situ cervical cancer
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (Complete Remission + Partial Remission) per the International Working Group Criteria (IWG, 2007)
    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 No
    E.6.11Pharmacogenomic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 Information not present in EudraCT
    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 EEA30
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 250
    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)
    Subjects with Complete Remmission, Partial Remission or Stable Disease may be eligible to continue to receive YM155 if they meet retreatment criteria and with agreement from the Investigator and Astellas Medical Monitor as part of an extension study.
    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 Decision2007-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-15
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