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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-005655-13
    Sponsor's Protocol Code Number:TRY
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Suspended by CA
    Date on which this record was first entered in the EudraCT database:2012-05-10
    Trial 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 number2011-005655-13
    A.3Full title of the trial
    A phase II trial to evaluate safety and efficacy of combined trastuzumab and AUY922
    in advanced non-small cell lung cancer (NSCLC) with HER2 - overexpression or -
    amplification or - mutation.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trastuzumab and AUY922 in HER2-aberrant NSCLC
    A.3.2Name or abbreviated title of the trial where available
    TRY
    A.4.1Sponsor's protocol code numberTRY
    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 SponsorUniversity of Cologne
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRoche
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportNovartis
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Cologne
    B.5.2Functional name of contact pointLung Cancer Group Cologne
    B.5.3 Address:
    B.5.3.1Street AddressKerpener Str. 62
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50937
    B.5.3.4CountryGermany
    B.5.4Telephone number004922147887008
    B.5.5Fax number004922147887010
    B.5.6E-maillungenkrebs@uk-koeln.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.4Pharmaceutical form Powder for 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 INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.3Other descriptive namerhuMAb
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) 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 RoleComparator
    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 nameAUY922
    D.3.2Product code AUY922
    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 INNAUY922
    D.3.9.1CAS number 747412-49-3
    D.3.9.3Other descriptive nameNVP-AUY922
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNVP-AUY922
    D.3.9.3Other descriptive nameAUY922
    D.3.9.4EV Substance CodeSUB30583
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    Advanced non-small
    cell lung cancer with HER2 - overexpression or - amplification or - mutation
    E.1.1.1Medical condition in easily understood language
    Lungcancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung 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 evaluate efficacy of combined trastuzumab and AUY922 in HER2 - overexpressed
    or - amplified or - mutated NSCLC
    E.2.2Secondary objectives of the trial
    • To evaluate the response rate in patients treated with trastuzumab monotherapy
    • To evaluate the tolerability of trastuzumab and AUY922 in combination
    (endpoints: assessment of adverse events (AEs) according to CTC-AE V4.0)
    • To evaluate the clinical efficacy of trastuzumab monotherapy and the
    combination descriptively (endpoints: progression-free survival (PFS), overall
    survival (OS))
    • To assess correlation of outcome parameters with the type of genetic aberration of
    HER2 (amplification, mutation) descriptively
    • To assess pharmacokinetics of AUY922 and trastuzumab
    • To establish a pharmacokinetic / pharmacodynamic model with regard to
    response rate and adverse events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Stage IV NSCLC patients after failure of at least one standard therapy with HER2 protein overexpression (HER2 score 3+) or gene amplification (FISH
    positive) or mutation
    • Age > 18 years
    • ECOG performance status 0 to 2
    • Life expectancy of at least 12 weeks
    • Evaluable disease or disease measurable per Response Evaluation Criteria in
    Solid Tumors (RECIST)
    • Adequate bone marrow, liver and renal function and adequate electrolyte
    balance as assessed by the following laboratory requirements conducted at least
    14 days prior to treatment:
    o Hemoglobin ≥ 8.5 g/dL
    o Absolute neutrophil count (ANC) ≥ 1000 / μl
    o Platelet count ≥ 80,000/μL
    o Total bilirubin ≤ 2 x ULN
    o ALT, AST and alkaline phosphatase (AP) ≤ 2.5 x ULN
    o PT-INR/PTT < 1.5 x ULN
    o Creatinine clearence (CrCl) ≥ 60ml/min calculated by either MDRD-formel or
    by 24 hours urine collection
    o Total calcium (corrected for serum albumin) within normal limits or
    correctable with supplements.
    o Magnesium within lower normal limits or correctable with
    supplements
    • Written informed consent (after adequate explanation of the trial) to participate
    in the trial and to adhere to trial procedures, as well as consenting to data
    protection procedures
    • In case of females with childbearing potential (definition of menopause is no
    bleeding at least 12 months after last menstruation):
    - negative serum pregnancy test in women with childbearing potential
    - effective method of contraception (Pearl-Index not greater than 1%)
    E.4Principal exclusion criteria
    • Known hypersensitivity to any study medication
    • Other history of ongoing malignancy that would potentially interfere with the
    interpretation of efficacy
    • Previous treatment with Hsp90 inhibitors (e.g.17-AAG)
    • Treatment with therapeutic doses of sodium warfarin (coumadin). Low doses
    of coumadin (e.g. < 2mg/day) are permitted
    • Patients with concurrent severe and/or uncontrolled medical conditions (e.g.
    uncontrolled diabetes mellitus, active untreated or uncontrolled infection,
    chronic obstructive or chronic restrictive pulmonary disease including
    dyspnea at rest from any cause or requiring supplementary oxygen therapy)
    that could cause unacceptable safety risks or compromise compliance with
    the protocol
    • Impaired cardiac function including any of the following:
    o History (or family history) of long QT syndrome
    o Mean QTc ≥ 450 msec on screening ECG
    o History of clinically manifest ischemic heart disease ≤ 6 months prior
    to start of the study
    o History of heart failure or left ventricular (LV) dysfunction (LVEF ≤
    45%) by transthoracic echocardiography
    o Clinically significant ECG abnormalities including one or more of
    the following: left bundle brunch block (LBBB), right bundle brunch
    block (RBBB) with left anterior hemiblock (LAHB), ST segment
    elevations or depressions > 1 mm or 2nd (Mobitz II) or 3rd degree AV
    block
    o History or presence of atrial fibrillation, atrial flutter or ventricular
    arrhythmias including ventricular tachycardia or torsades de pointes
    o Other clinically significant heart disease (e.g. congestive heart
    failure, uncontrolled hypertension or history of unstable
    hypertension)
    o Clinically significant resting bradycardia (< 50 beats per minute)
    o Patients who are currently receiving treatment with any medication
    which has a relative risk of prolonging the QTc interval or inducing
    torsades de pointes and cannot be switched or discontinued to an
    alternative drug prior to commencing AUY922
    o Obligate use of a cardiac pacemarker
    o Angina pectoris requiring a medicinal producto Evidence of transmural infarction on ECG
    o Clinically significant valvular disease
    • Known diagnosis of HIV, active hepatitis B and/or C (testing is not
    mandatory)
    • Clinically symptomatic leptomeningeal or brain metastases (patients with
    clinically stable brain metastases may be enrolled)
    • Any person being in an institution on assignment of the respective authority
    • Any medical, mental or psychological condition which in the opinion of the
    investigator would not permit the patient to complete the study or understand
    the patient information
    • Any serious medical condition with organ impairment
    • Parallel participation in another clinical trial
    • Experimental or other therapy within the last 30 days or 5 half-life's,
    whatever is of longer duration (with exception of trastuzumab, if patient is
    recruited directly for combination treatment)
    • Pregnancy, breast feeding
    E.5 End points
    E.5.1Primary end point(s)
    • Response rate
    • Assessment of adverse events (AEs) according to CTC-AE V4.0
    • progression-free survival (PFS), overall
    survival (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    CT every 6 weeks
    E.5.2Secondary end point(s)
    • Assessment of adverse events (AEs) according to CTC-AE V4.0
    • progression-free survival (PFS), overall
    survival (OS)
    • To assess correlation of outcome parameters with the type of genetic aberration of
    HER2 (amplification, mutation) descriptively
    • To assess pharmacokinetics of AUY922 and trastuzumab
    • To establish a pharmacokinetic / pharmacodynamic model with regard to
    response rate and adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Every visit during the trial
    • CT every 6 weeks, contact by phone every 6 months (after study discontinuation)
    • Assessment of genetic type (once Screening phase) and CT every 6 mont
    • PK D1, D2, D5, D8, D22, D36, after then 2 weekly
    • To establish a pharmacokinetic / pharmacodynamic model with regard to
    response rate and adverse events
    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 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 Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.2.1Number of subjects for this age range: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state29
    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)
    Standard therapy or best supportive care may be offered as well as participation in another clinical trial after discontinuation of the trial. Further treatment will be offered at the study site. The patient may nevertheless change the treating institution, if wished.
    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 Decision2012-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-30
    P. End of Trial
    P.End of Trial StatusSuspended by CA
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