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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2007-006050-25
    Sponsor's Protocol Code Number:20060362
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-02-01
    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 ConcernedGermany - PEI
    A.2EudraCT number2007-006050-25
    A.3Full title of the trial
    An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 with Exemestane or Fulvestrant in Postmenopausal Women with Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
    A.4.1Sponsor's protocol code number20060362
    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 SponsorAmgen 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 nameAMG 479
    D.3.2Product code AMG 479
    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 codeAMG479
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Role
    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 holderAstraZeneca UK Limited
    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 namefulvestrant
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    To provide an estimate of the relative efficacy of Arm A (AMG 479 in combination with
    endocrine therapy [exemestane or fulvestrant] versus Arm B (AMG 479 placebo in combination with endocrine therapy [exemestane or fulvestrant]) as measured by the PFS hazard ratio. This estimate will be precise enough to provide guidance for further development of AMG 479.for use in the planning of a phase 3 study in this patient population. Additionally, this study will provide qualitative estimates of PFS for treatment arms A and B.
    E.2.2Secondary objectives of the trial
    To investigate the effect of AMG 479 compared with placebo when administered in combination with exemestane or fulvestrant on:
    • the safety and tolerability
    • the impact to patient reported outcomes (PROs)
    • the pharmacokinetics (PK) of AMG 479
    • additional efficacy measures including clinical benefit rate, objective response rate, duration of response, time to progression (TTP), time-to-response, time-to-treatment failure, and survival time
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Disease related
    • Histologically or cytologically confirmed carcinoma of the breast with locally advanced or metastatic disease not amenable to surgery or radiation with curative intent (based on medical history review)
    • Confirmation of hormone receptor (ER and/or progesterone receptor) positive disease using institutional standards for analysis of the primary tumor tissue or tissue obtained thereafter (based on medical history review)
    • Amenable to receive endocrine therapy as per investigator discretion
    • Disease progression while receiving prior endocrine therapy for locally advanced or metastatic breast cancer or recurrence while receiving prior endocrine therapy as adjuvant treatment or within 12 months of treatment discontinuation.
    • Measurable or non-measurable disease, as defined by RECIST criteria
    • Eastern Cooperative Oncology Group (ECOG, refer to Appendix I) performance status of 0 or 1
    • Documented life expectancy greater than 3 months

    Demographic
    • Woman ≥ 18 years old
    • Postmenopausal as defined by any of the following criteria:
    - History of bilateral oophorectomy, or
    - Age ≥ 55 years old, or
    - ≥ 45 years old with amenorrhea for ≥ 12 months, or
    - ≥ 45 years old with amenorrhea and follicle stimulating hormone concentrations within postmenopausal range, or
    - Follicle stimulating hormone concentrations within postmenopausal range in patients previously treated with bilateral ovarian radiation, or patients with chemotherapy induced amenorrhea

    Laboratory
    • Hematological function, as follows:
    - Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
    - Platelet count ≥ 100 x 109/L
    - Hemoglobin ≥ 9 g/dL
    • Partial thromboplastin ≤ 1.3 x upper limit of normal (ULN) and international normalized ratio (INR) ≤ 1.5, unless subject is on anticoagulation therapy. Subjects on therapeutic anticoagulation are eligible if they will be prescribed exemestane as their endocrine therapy on the study, there is no bleeding and they are on a stable dose of anticoagulation therapy (eg, on coumadin with an INR of 2 to 3) for at least 7 days before randomization.
    • Renal function, as follows:
    - Serum creatinine ≤ 1.5 x the ULN or calculated creatinine clearance (by Cockcroft-Gault formula) ≥ 40 mL/min
    • Hepatic function, as follows:
    - Aspartate aminotransferase (AST) ≤ 2.5 x ULN
    - Alanine aminotransferase (ALT) ≤ 2.5 x ULN
    - Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN with bone/liver metastases)
    - Bilirubin ≤ 1.5 x ULN or if total bilirubin < 3 X ULN if subject has UGT1A1 promoter polymorphism (ie, Gilbert syndrome) confirmed by genotyping or Invader® UGT1A1 Molecular Assay prior to randomization.
    • Adequate glycemic function, for subjects with known diabetes (Type 1 or 2), as
    follows:
    - Must be controlled with a glycosylated hemoglobin (HgbA1c) of < 8.0%
    - Documented fasting blood sugars < 160 mg/dL. Diabetic subjects who have recently had their glycemic control regimens adjusted and have documented fasting blood glucose concentrations < 160 mg/dL may be considered, regardless of HgbA1c value, if per investigator discretion are considered to have adequate glycemic function
    E.4Principal exclusion criteria
    Disease Related
    • HR-unknown, or -negative disease (based on medical history review)
    • Not amenable to receive endocrine therapy, including but not limited to, inflammatory breast cancer, rapidly progressing disease, or symptomatic visceral
    disease
    • Central nervous system metastases, unless previously treated by either radiation therapy and/or surgical resection, who are clinically stable off corticosteroids before randomization
    • Prior malignancy except the following is allowable:

    • Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician

    • Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease

    • Adequately treated cervical carcinoma in situ without evidence of disease

    Medications
    • More than 1 prior endocrine regimen for metastatic breast cancer, or locally advanced breast cancer. There are no restrictions for their administration in the neoadjuvant or adjuvant settings, except subjects should not have previously been treated with the endocrine therapy planned for use in this study
    • More than 1 prior regimen including immunotherapy (eg, vaccines), antibody therapy (eg, trastuzumab, bevacizumab), small-molecule therapy (eg, lapatinib) for metastatic breast cancer, or locally advanced breast cancer, although there are no restrictions for their administration in the neoadjuvant or adjuvant settings
    • More than 1 prior regimen including chemotherapy for metastatic breast cancer,
    or locally advanced breast cancer, although there are no restrictions for their administration in the neoadjuvant or adjuvant settings
    • For subjects with measurable disease, previous radiation therapy to a lesion being used for RECIST assessment, unless it has subsequently progressed after completion of therapy
    • Administration of prior endocrine anticancer therapies within 1 week of randomization
    • Administration of other prior anticancer therapies within 2 weeks of randomization
    • Toxicities related to prior anticancer treatment (except alopecia) have not resolved to common terminology criteria for adverse events version 3.0 (CTCAE V 3.0) defined ≤ grade 1 before randomization
    • Prior treatment with investigational treatment targeted to IGF axis including, but not limited to, CP 751,871, IM-A12, RO4858696
    • Previous exposure to AMG 479
    • Currently receiving systemic antibiotic therapy for the treatment of an active infection
    • Requirement for other endocrine therapy including:
    - systemic hormone-replacement therapy or intravaginal estrogen
    - megestrol acetate

    General
    • History of bleeding diathesis
    • Known positive test for human immunodeficiency virus, or chronic hepatitis B or C infection
    • Any co-morbid medical condition that may put the subject at significant risk for toxicity
    • Major surgical procedure within 28 days of randomization
    • Minor surgical procedures within 7 days of randomization, although placement of central access device, fine needle aspiration, thoracentesis or paracentesis > 1 day before randomization is acceptable
    • Inability to tolerate IV drug administration
    • Has not yet completed at least 30 days before randomization since ending other investigational device or drug study(s)
    • Subject has known sensitivity to any of the products to be administered during dosing
    • Subject previously randomized to this study
    • Subject will not be available for follow-up assessments
    • Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
    • Unable to initiation study treatment within 3 days of randomization
    E.5 End points
    E.5.1Primary end point(s)
    To provide an estimate of the relative efficacy of Arm A (AMG 479 in combination with endocrine therapy [exemestane or fulvestrant] versus Arm B (AMG 479 placebo in combination with endocrine therapy [exemestane or fulvestrant]) as measured by the PFS hazard ratio. This estimate will be precise enough to provide guidance for further development of AMG 479.for use in the planning of a phase 3 study in this patient population. Additionally, this study will provide qualitative estimates of PFS for treatment arms A and B.
    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 Yes
    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 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 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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 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
    The end of the clinical study is when all subjects have completed the long-term follow-up (up to a maximum of 48 months from the date the last subject is enrolled), withdrawn of consent, lost-to-follow up or died.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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.1.1.2Preterm 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 150
    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 Decision2008-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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