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    The EU Clinical Trials Register currently displays   35522   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-012439-14
    Sponsor's Protocol Code Number:155-CL-036
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-22
    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 ConcernedIreland - HPRA
    A.2EudraCT number2009-012439-14
    A.3Full title of the trial
    A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects with HER2 Negative Metastatic Breast Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of YM155 plus docetaxel as the first treatment option for patients with Her2 negative metastatic breast cancer
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code number155-CL-036
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01038804
    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 SponsorAstellas Pharma Global Development, Inc. (APGD)
    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 supportAstellas Pharma Global Development, Inc. (APGD)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Global Development, Inc. (APGD)
    B.5.2Functional name of contact pointT.B Smagge
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 71 545 5163
    B.5.5Fax number+31 71 545 5840
    B.5.6E-mailpuma.smagge@eu.astellas.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.3.1Product nameYM155
    D.3.2Product code YM155
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 781661-94-7
    D.3.9.2Current sponsor codeYM155
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 Information not present in EudraCT
    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 nameDocetaxel
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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.3.8INN - Proposed INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Adenocarcinoma of the breast that is HER2 negative.
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    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 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the progression free survival (PFS) between the YM155 plus Docetaxel and the Docetaxel regimen.
    E.2.2Secondary objectives of the trial
    • Objective response rate (ORR)
    • Overall survival (OS)
    • Duration of response (DOR)
    • Clinical benefit rate (CBR)
    • Time to response (TTR)
    • Safety and tolerability
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The pharmacogenomic sub-study is included in the main protocol.

    Study objectives are to comprehensively analyze:
    • Suspected disease-related genes such as oncogenes, survivin and vascular
    endothelial growth factor (VEGF)
    • Genes potentially involved in drug excretion and/or metabolism such as the organic
    anion/cation transporters (OAT, OCT)
    • Genes of relevance to toxicity/safety issues, to be identified in a precautionary /
    retrospective setting
    E.3Principal inclusion criteria
    A subject is eligible for the study if all of the following apply:
    1. The subject prior to any study-related procedures (including withdrawal of prohibited medicines, if applicable) has provided Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)- approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for US sites).

    2. The subject is male or female and aged 18 years or older at the Baseline Visit with
    metastatic breast cancer.

    3. The subject has histologically- or cytologically-proven adenocarcinoma of the
    breast that is HER2 negative defined as one of the following:
    o Negative fluorescence in-situ hybridization (FISH).
    o 0 or 1+ immunohistochemistry (IHC).
    o IHC 2+ with negative FISH.
    Subjects with hormone receptor positive or negative status are eligible. Additionally,
    subjects with triple negative status (meaning estrogen receptor negative, rogesterone receptor negative and HER2 negative) are eligible.

    4. The subject has received no prior chemotherapy regimen for metastatic breast cancer.
    o Prior treatment with a cytotoxic therapy (other than docetaxel) is allowed if
    administered in the neoadjuvant or adjuvant setting >3 weeks prior to the Baseline
    Visit, with all side effects of using prior cytotoxic therapy resolved or back to
    baseline (with the exception of weight loss or gain, anorexia, alopecia or fatigue).
    o Prior treatment with docetaxel is allowed if administered in the neoadjuvant or
    adjuvant setting, and the subject has no recurrent disease within 12 months after
    completing treatment, with all side effects of prior docetaxel use resolved or back to
    baseline (with the exception of weight loss or gain, anorexia, alopecia or fatigue).
    o Prior treatment with a kinase inhibitor, biologic therapy, vaccine, or investigational treatment other than cytotoxic therapy or procedure for breast cancer is allowed if administered in the neoadjuvant, adjuvant or metastatic setting ≥ 4 weeks prior to the Baseline Visit.
    o Prior treatment with hormonal therapy in the neoadjuvant, adjuvant or metastatic setting is allowed if administered ≥ 2 weeks prior to the Baseline Visit.
    o Prior treatment with bevacizumab is allowed if administered in the neoadjuvant or adjuvant setting >4 weeks prior to the Baseline Visit.

    5. Prior palliative radiation therapy is allowed if treatment was completed ≥ 2
    weeks prior to the Baseline Visit with side effects from radiation resolved.

    6. The subject has an Eastern Cooperative Oncology Group (ECOG) performance
    status ≤ 1 at the Baseline Visit.

    7. The subject has at least one measurable lesion by RECIST (Version 1.1).
    o If the selected lesion(s) received prior radiation and/or loco-regional therapy,
    there must be evidence of disease progression since the last radiation or
    locoregional therapy.

    8. If the subject has a previous history of non-breast cancer malignancy, the subject must meet the following criteria for a cancer survivor:
    o Subject having a previous history of a non-invasive carcinoma is eligible if in the opinion of the Investigator, he/she has successful curative treatment anytime prior to enrollment.
    o For all other malignacies, the subject has undergone potentially curative therapy and the subject has been considered disease free for at least 5 years.

    9. The subject’s life expectancy is estimated to be > 12 weeks at the Baseline Visit.

    10. The subject must be non-pregnant and non-lactating. Each site will administer a
    pregnancy test to any female of childbearing potential during the Screening
    Period and at the Baseline Visit. Only subjects with negative pregnancy test
    results will be eligible. All sexually active subjects of childbearing potential must
    agree to use an adequate method of contraception throughout the study period.
    E.4Principal exclusion criteria
    A subject will be excluded from participation if any of the following apply:

    1. The subject has hypersensitivity to docetaxel or polysorbate 80.

    2. The subject has had a major surgical procedure, substantial open biopsy, or significant traumatic injury within 28 days prior to the Baseline Visit or anticipation of need for major surgical procedure during the course of the study.

    3. The subject has neuropathy ≥ Grade 2 at the Baseline Visit.

    4. The subject has inadequate marrow, hepatic and/or renal function at the Baseline Visit defined as:
    o Serum creatinine ≥ 1.5 x ULN or calculated serum creatinine clearance < 60
    mL/min.
    o ANC < 1500/mm3.
    o Platelets ≤ 100,000/mm3.
    o Alanine Transaminase (ALT) or Aspartate Transaminase (AST) >2.5 x ULN, or
    >5 x ULN in subjects who have documented liver metastases.
    o Bilirubin > ULN.
    o Hemoglobin <9 gm/dL

    5. Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination.

    6. The subject has a known history of positive test for Hepatitis B surface Antigen
    (HsbAg) or hepatitis C antibody or history of positive test for Human
    Immunodeficiency Virus (HIV).

    7. The subject has significant and/or uncontrolled cardiac, renal, hepatic or other
    systemic disorders or significant psychological conditions at Baseline Visit that in
    the Investigator’s judgment would jeopardize subject enrollment or compliance
    with the study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the study is progression free survival (PFS). PFS is defined as the time from the date of randomization until objective tumor progression or death. Objective tumor progression includes radiological assessments by independent reviewers blinded for the treatment assignment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 67 Progression Free Events have been observed in the study.
    E.5.2Secondary end point(s)
    - Objective response rate
    - Overall survival
    - Duration of response
    - Clinical benefit rate
    - Time to response
    - Safety and Tolerability
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 67 Progression Free Events have been observed in the study.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Potential efficacy biomarkers
    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 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.8.2.4Number of treatment arms in the trial2
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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 Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    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
    End of study reflects when the last subject receives the last survival
    contact. The End of Study date could include a study visit, successful
    telephone contact, etc. Definition provided in the protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days14
    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.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 100
    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)
    After participating in the trial, the subject will be treated with standard of care provided by the site.
    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 Decision2010-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-27
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