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    Summary
    EudraCT Number:2010-020116-11
    Sponsor's Protocol Code Number:CAUY922A2206
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-09-28
    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 number2010-020116-11
    A.3Full title of the trial
    A phase II, multi-center, open-label study of AUY922 administered IV on a once-weekly schedule in patients with advanced non-small-cell lung cancer who have received at least two lines of prior chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    a clinical study investigating the safety and efficacy of AUY922 in
    patients with advanced lung cancer
    A.4.1Sponsor's protocol code numberCAUY922A2206
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01124864
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice
    B.5.3 Address:
    B.5.3.1Street AddressRoonstr. 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number+491802232300
    B.5.5Fax number+4991127312160
    B.5.6E-mailinfoservice.novartis@novartis.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 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.3.9.1CAS number 747412-49-3
    D.3.9.2Current sponsor codeAUY922
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with advanced non-small-cell lung cancer who have received at least two lines of prior chemotherapy
    E.1.1.1Medical condition in easily understood language
    patients with advanced lung cancer who have received previous
    chemotherapies
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10066490
    E.1.2Term Progression of non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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 estimate efficacy for each study strata at 18 weeks as assessed by
    RECIST
    The following strata will be assigned:
    1. Patients with EGFR activating mutation tumors
    2. Patients with KRAS mutant tumors
    3. Patients with EML4-ALK translocations
    4. Patients with EGFR wt and KRAS wt tumors
    5. Modified stratum for patients with EGFR activating mutation tumors
    E.2.2Secondary objectives of the trial
    - To estimate overall survival (OS) and progression free survival (PFS) in
    patients with
    advanced NSCLC receiving AUY922.
    - To determine safety and tolerability of AUY922 i.v. monotherapy in
    advanced NSCLC
    patients.
    - To assess the pharmacokinetics (PK) profile of AUY922 in NSCLC
    patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients with histologically or cytologically confirmed advanced (stage
    IIIB or stage IV) NSCLC who have received at least two prior lines of
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    treatment. Patients who, in the investigators opinion, are deemed
    unsuitable for the standard 2nd line chemotherapy will be eligible for
    protocol participation. One of the prior lines must have included a
    platinum agent. Prior treatment with a platinum agent is not a
    requirement for EGFR mutant patients and patients with EML4-ALK
    translocations.
    • Patients enrolled to the fifth stratum, modified EGFR mutant, must
    have documented prior response to EGFR TKI as defined by CR, PR or SD
    for 6 months or greater unless patient has de novo resistance to EGFR
    TKI (e.g. exon 20 insertions.) • All patients must have at least one measurable lesion as defined by
    RECIST criteria. Previously irradiated lesions are not measurable unless
    the lesion is new or has demonstrated clear progression after radiation.
    • World Health Organization (WHO) performance status ≤ 2. For patients
    enrolled to the fifth stratum, modified EGFR mutant, World Health
    Organization (WHO) performance status ≤ 1.
    • Patients enrolled to the fifth stratum, modified EGFR mutant, must be
    willing and suitable to undergo fresh baseline biopsy prior to study
    treatment (unless patient had recent biopsy after EGFR TKI progression
    that concluded resistance to EGFR TKI.)
    • Hematologic:
    o Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L.
    o Hemoglobin (Hgb) ≥ 9 g/dl.
    o Platelets (plt) ≥ 100 x 109/L.
    • Biochemistry:
    o Total calcium (corrected for serum albumin) within normal limits or
    correctable with supplements.
    o Magnesium within lower normal limits or correctable with
    supplements.
    • Adequate liver function defined as:
    o AST/SGOT and ALT/SGPT ≤ 3.0 x Upper limit of Normal (ULN) or ≤
    5.0 x ULN if liver metastasis are present.
    o Serum bilirubin ≤ 1.5 x ULN.
    o Serum albumin > 2.5 g/dL.
    o Serum creatinine ≤ 1.5 x ULN or 24 hour clearance ≥ 50 mL/mi
    Other protocol-defined inclusion criteria may apply
    E.4Principal exclusion criteria
    • Patients who have received more than four lines of prior treatment.
    Exception: Patients enrolled to the fifth stratum, modified EGFR mutant,
    must not have received more than two prior lines of therapy.
    Chemotherapy administered as adjuvant treatment more than six
    months prior to study enrollment is not considered a prior line of therapy
    for purposes of this study.
    • Patients with a history of CNS metastasis. Note: Patients without
    clinical signs and symptoms of CNS involvement are not required to have
    MRI of the brain. Exception: Patients with treated brain metastases who
    are asymptomatic, who has discontinued corticosteroids, and who have
    been clinically stable for one month will be eligible for protocol
    participation. This exception is not valid for patients enrolled to the fifth
    stratum, modified EGFR mutant. These patients must not have CNS
    involvement.
    • Prior anti-neoplastic treatment with any HSP90 or HDAC inhibitor
    compound.
    • Patients must not have received:
    o any systemic anti-cancer treatment or radiotherapy within 4 weeks
    prior to first dose of study treatment and should have recovered to baseline or less than Grade 1 from toxicities of such therapy prior to the
    first dose of study treatment
    o 2 weeks for palliative radiotherapy to bones, 6 weeks for nitrosoureas
    and mitomycin
    o 4 weeks for monoclonal antibodies
    o and ≤5 half-life of the agent or active metabolities [if any] for
    continuous systemic anti-cancer treatment or investigational
    • Patients who do not have either an archival tumor sample available or
    are unwilling to have a fresh tumor sample collected at baseline
    Other protocol-defined exclusion criteria may apply
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy as assessed by RECIST, to be classified as response (complete or partial), stable disease at 18 weeks, or no clinical benefit (NCB)
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 weeks
    E.5.2Secondary end point(s)
    • Efficacy; OS, PFS as assessed by RECIST.
    • Safety parameters: Adverse drug reactions and serious adverse drug
    reactions, changes in hematology and chemistry values, including those
    associated with hepatic and renal function, and assessment of physical
    examinations, vital signs, ocular symptoms and cardiac function (i.e.
    repeated electrocardiograms). CTCAE version 4.0 will be used.
    • Pharmacokinetics: Exposure of AUY922 in plasma. Parameters
    assessed include AUC, Cmax, Tmax, CL, and Vz.
    Additional secondary endpoints as defined in the protocol
    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 Yes
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Canada
    France
    Germany
    Korea, Republic of
    Netherlands
    Norway
    Singapore
    Spain
    Turkey
    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
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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.4.2.2In 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 Decision2010-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-07-13
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