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    The EU Clinical Trials Register currently displays   35495   clinical trials with a EudraCT protocol, of which   5837   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-003228-20
    Sponsor's Protocol Code Number:155-CL-007
    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:2005-09-12
    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 number2005-003228-20
    A.3Full title of the trial
    A PHASE II, MULTI-CENTER, OPEN-LABEL STUDY OF YM155 IN SUBJECTS WITH HORMONE REFRACTORY PROSTATE CANCER (HRPC) PREVIOUSLY TREATED WITH AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
    A.4.1Sponsor's protocol code number155-CL-007
    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 SponsorYamanouchi Europe B.V. (to be renamed Astellas Pharma Europe B.V by August 2005)
    B.1.3.4CountryNetherlands
    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 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 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 codeYM 155
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Male adults with Hormone Refractory Prostate Cancer who have progressed, as evidenced by PSA progression or progression of measurable disease, after at least 1 prior chemotherapy regimen.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10062904
    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 efficacy of YM155 based on the percentage of subjects that obtain a PSA response.
    PSA response is defined as a ≥ 50% reduction in PSA that is confirmed by a second PSA value 3 weeks apart. The reference PSA value for these decreases is the baseline PSA value.
    E.2.2Secondary objectives of the trial
    Secondary
    • To measure the percentage of PSA decrease.
    • To measure duration of PSA response.
    • To measure the time to PSA progression.
    • To evaluate overall survival (OS).
    • To measure objective tumor response (Complete Response [CR] and Partial Response [PR]) in subjects with measurable disease.
    • To measure change in pain based upon Memorial Pain Scale.
    • To evaluate progression free survival (PFS).
    • To evaluate safety based on clinical laboratory assessments, 12-lead ECGs, vital signs, physical examinations, and adverse events.

    Additional Exploratory Objectives:
    • To assess population pharmacokinetics of YM155.
    • Alpha-1-acid glycoprotein (AAG) will be obtained on all subjects at baseline and at
    the Final Visit/Early Termination in order to evaluate the level of AAG in relation to
    treatment outcomes and survival.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subjects are eligible for the study if all of the following apply:
    1) Written informed consent and HIPAA (U.S. sites only) authorization have been
    obtained.
    2) Male subjects ≥18 years of age with histologically or cytologically confirmed prostate cancer.
    3) Subject has a serum testosterone level < 50 ng/dL.
    4) Subject has been treated with at least 1 prior chemotherapy regimen. For US subjects, the subject had to have at least 1 regimen containing taxotere and prednisone.
    5) PSA at baseline must be at least 5 ng/mL.
    6) Subject has evidence of disease progression on hormonal therapy and following at
    least one course of chemotherapy. Disease progression prior to study entry is defined by any of the following:
    a. Appearance of at least one new lesion on bone scintigraphy or X-ray as compared
    to previous evaluations, or
    b. Appearance of new soft tissue disease or an increase of at least 20% in the sum of the largest diameters of the previously measurable soft tissue disease as
    documented by appropriate imaging modality, or
    c. A rising PSA defined as an increase in PSA on 2 consecutive measurements
    separated by at least 1 week compared to a reference PSA.
    7) ECOG performance status 0-2.
    8) Life expectancy greater than 12 weeks.
    9) Willingness to comply with all procedures and assessments.
    10) In the case of medical castration, subject is receiving stable dose of LHRH-agonist or LHRH-antagonist.
    11) Subject must be off anti-androgen therapy at least 4 weeks prior to dosing for
    flutamide and other secondary hormonal therapy and 6 weeks for nilutaminde and
    bicalutamide.
    E.4Principal exclusion criteria
    Subjects will be excluded from the study if they meet any of the following criteria:
    1) Radiation therapy within 4 weeks prior to the start of YM155.
    2) Prior strontium or samarium or other radioisotope therapy within 12 weeks prior to
    start of YM155.
    3) Has metastases to the brain.
    4) Concurrent anticancer therapy (chemotherapy, vaccines, immunotherapy) delivered within the last 4 weeks (6 weeks for nitrosoureas or mitomycin C, or other agents known to cause prolonged marrow suppression) except for continued use without modification of LHRH-agonists, LHRH-antagonists, and bisphosphonates initiated 4 weeks or more before the start of YM155.
    5) History of other malignancy in the last 5 years.
    6) Participated in a clinical study involving an investigational drug or device within
    4 weeks prior to the start of YM155.
    7) Known history of positive test for hepatitis B surface antigen (HbsAg) or hepatitis C antibody or history of positive test for human immunodeficiency virus (HIV) infection.
    8) Had major surgery within the past 21 days prior to the start of YM155.
    9) Uncontrolled intercurrent illness, including but not limited to ongoing or active
    infection, symptomatic congestive heart failure, unstable angina pectoris, unstable
    cardiac arrhythmia, seizure disorder, or psychiatric illness/social situations that would
    limit compliance with study requirements.
    10) Subjects with a urine protein of 2+ (grade 2) and above prior to start of YM155.
    11) Has inadequate bone marrow, renal, and hepatic function as evidenced by:
    a. Absolute neutrophil count (ANC) ≤ 1500/mm3 and platelet count ≤ 100,000/mm3,
    b. Serum creatinine ≥ 1.5 upper limit of normal (ULN) or calculated creatinine
    clearance < 60 mL/min at screening,
    c. Total bilirubin ≥ 1.5 times the upper limit of normal (ULN) National Cancer
    Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
    Grade 1,
    d. Alanine transaminase (ALT) and aspartate transaminase (AST) ≥ 2.5 X ULN (NCI
    CTCAE Grade 1); if the subject has documented liver metastases and/or hepatoma,
    ALT and AST ≥ 5 X ULN.
    12) Any clinical condition, which, in the opinion of the investigator, would not allow safe conduct of the study.
    13) Use of any alternative medications (e.g. herbal supplements) within 2 weeks prior to the start of study drug.
    E.5 End points
    E.5.1Primary end point(s)
    • The rate of PSA response. PSA response is defined as a ≥ 50% reduction in PSA without evidence of clinical or radiographic disease progression that is confirmed by a second PSA value 3 weeks apart. The reference PSA value for these decreases is the baseline PSA value.
    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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2005-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-03-30
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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