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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2006-005305-58
    Sponsor's Protocol Code Number:H6Q-MC-S023
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-005305-58
    A.3Full title of the trial
    A Randomized, Double-Blind, Phase 2 Trial of Fulvestrant Plus Enzastaurin versus Fulvestrant Plus Placebo in Aromatase Inhibitor-Resistant Metastatic Breast Cancer
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberH6Q-MC-S023
    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 SponsorEli Lilly and Company limited
    B.1.3.4CountryUnited Kingdom
    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 nameEnzastaurin
    D.3.2Product code LY317615
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEnzastaurin Hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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.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 Yes
    D.2.1.1.1Trade name Faslodex
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameFaslodex
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfulvestrant
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    metastatic breast cancer, resistant to aromatase inhibitors
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main objective : To compare the clinical benefit rate between fulvestrant plus enzastaurin and fulvestrant plus placebo in Aromatase Inhibitor resistant MBC.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    o to compare the clinical benefit rate between 2 pairs of patient cohorts:
    (1) fulvestrant plus enzastaurin BID and fulvestrant plus placebo;
    (2) fulvestrant plus enzastaurin QD and fulvestrant plus placebo
    o to compare the following endpoints between the randomized treatment
    arms 3 pairs of patient cohorts: (1) all fulvestrant plus enzastaurin patients
    (BID+QD) and fulvestrant plus placebo; (2) fulvestrant plus enzastaurin
    BID and fulvestrant plus placebo; (3) fulvestrant plus enzastaurin QD and
    fulvestrant plus placebo:
    o response rates (RR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines
    o duration of clinical benefit
    o progression-free survival (PFS)
    o safety and adverse event profile using Common Terminology Criteria for Adverse Events
    o assess biomarkers relevant to enzastaurin and the disease state, as well as their correlation to clinical outcome.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be included from the study if they meet all of the following criteria:
    [1] Female patients with a histological-documented diagnosis of locally advanced or metastatic breast cancer. The primary or metastatic tumor must be ER and/or PR receptor positive.
    [2] Patients are resistant to AI therapy
    • AI was administered in the adjuvant setting: patient should have been
    on treatment for at least 1 year and have had an objective recurrence
    during this treatment or in the first year after finishing it.
    • AI was administered in advanced disease:
    ο If patients have not received previous chemotherapy for MBC,
    they must have achieved a tumor response or stabilization lasting
    at least 6 months and have had an objective progression during
    treatment
    ο If patients have received previous chemotherapy for MBC, they
    can have 3 different situations
    ♦ Chemotherapy → AI (as maintenance of response).
    They must have received the AI lasting at least 6 months
    and have had an objective progression during treatment
    ♦ Chemotherapy → AI (at progression).
    They must have achieved a tumor response or stabilization
    lasting at least 6 months and have had an objective
    progression during treatment
    ♦ AI → Chemotherapy.
    They must have achieved a tumor response or stabilization
    to the AI and have had an objective progression after
    chemotherapy.
    [3] Females with postmenopausal status defined as:
    • Age ≥ 60 years or age ≥ 45 years and 24 months from the last menstrual period with intact uterus
    • Follicle-stimulating hormone level within postmenopausal range
    • Prior radiation, medical or surgical castration (such as bilateral salpingo-oophorectomy)
    [4] Previous radiation therapy is allowed, but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Lesions that have been irradiated cannot be included as sites of measurable disease unless clear tumor progression, according to RECIST criteria, has been documented in these lesions since the end of radiation therapy
    [5] Measurable or nonmeasurable disease defined by:
    • At least 1 unidimensionally measurable lesion meeting RECIST (Protocol Attachment S023.5; Therasse et al. 2000) Guidelines. Positron emission tomography (PET) scans and ultrasounds may not be used
    • At least 1 nonmeasurable lesion whose presence is assessable using standard techniques or a spiral CT scan even though the lesion is smaller than the minimum size required for measurability (PET scans and ultrasounds may not be used). Patients with bone lesion(s) in the absence of measurable disease can be recruited provided they can be evaluated by X-ray, CT or MRI (patients with lesions assessed only by bone scan cannot be included).
    (Note: The number of patients with evaluable-only (nonmeasurable, for example bone metastases) disease to be enrolled in the trial will be limited to a maximum of 40 patients)
    [6] Inclusion Criterion [6] has been deleted
    [7] Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale (Oken et al. 1982)
    [8] Have adequate organ function including the following:
    Adequate bone marrow reserve: white blood cell (WBC) count 3.0  109/L, absolute neutrophil count (ANC) 1.5  109/L, platelet count 75.0  109/L, and hemoglobin 10.0 g/dL (6.2 mmol/L).
    Hepatic: bilirubin 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) 2.5  ULN or 5 x ULN with liver metastases.
    Renal: serum creatinine 1.5 x ULN.
    [9] Are at least 18 years of age
    [10] Have an estimated life expectancy of at least 24 weeks
    [11] Exhibit patient compliance and geographic proximity that allow for adequate follow-up
    [12] Must sign an informed consent document (or legal representative has given informed consent)
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    [13] Have received treatment with more than 1 line of hormonal therapy in the metastatic setting
    [14] Have had prior treatment with fulvestrant or enzastaurin
    [15] Exclusion Criterion [15] has been deleted
    [16] Are receiving concurrent administration of any other antitumor therapy, with the exception of gonadotropin-releasing hormone (GnRH) antagonists.
    [17] Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry
    [18] Have received supplemental estrogen or progesterone within 4 weeks prior to study entry
    [19] Are HER2-positive
    [20] Are unable to discontinue use of anticoagulants
    [21] Have hypercalcemia: corrected calcium >10% over ULN
    [22] Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment
    [23] Have documented central nervous system (CNS) metastases, symptomatic pulmonary lymphangitis, or involvement of more than 1/3 of the liver (that is, patients with rapidly progressive disease, or those whose assessment dictates that chemotherapy would be more appropriate)
    [24] Have a serious concomitant systemic disorder (for example, active infection including HIV) incompatible with the study (at the discretion of investigator), previous history of bleeding diathesis, or coagulation treatment
    [25] Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV (Bruce RA 1956)
    [26] Are unwilling or unable to discontinue use of carbamazepine, phenobarbital, or phenytoin at least 14 days prior to study therapy
    [27] Are unable to swallow tablets.
    [28] Exclusion Criterion [28] has been deleted
    [30] Patients with osteoporosis, defined as bone mineral density (BMD) T
    score <2.5 SD (standard deviation) or receiving treatment for
    osteoporosis. Note: Patients with BMD T score between 1 to 2.5 are
    defined as osteopenia, which, in the opinion of the investigator, would
    compromise the safety of the patient or compromise the patient’s ability
    to complete the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure is the clinical benefit rate. Clinical benefit (CB) is defined as the best response of CR, PR, and SD for 24 weeks duration. The CB rate is defined, for each treatment arm, as the number of patients with the best response of CR, PR, and SD for 24 weeks duration divided by the number of randomized and treated patients.
    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 No
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Yes
    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.8.5The 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 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 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 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 years3
    E.8.9.2In all countries concerned by the trial months3
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 130
    F.4.2.2In the whole clinical trial 130
    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 Decision2007-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-18
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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