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    Summary
    EudraCT Number:2009-015628-27
    Sponsor's Protocol Code Number:CAUY922A2109
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-30
    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 ConcernedSweden - MPA
    A.2EudraCT number2009-015628-27
    A.3Full title of the trial
    A phase Ib/II, multi-center, open-label study to evaluate the efficacy of AUY922 in combination with Trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer, that has progressed after or during at least one Trastuzumab-containing regimen
    A.4.1Sponsor's protocol code numberCAUY922A2109
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Sverige AB
    B.5.2Functional name of contact pointMedicinsk information
    B.5.3 Address:
    B.5.3.1Street AddressKemistvägen 1b
    B.5.3.2Town/ cityTäby
    B.5.3.3Post code18379
    B.5.3.4CountrySweden
    B.5.4Telephone number+4687323200
    B.5.5Fax number+4687323201
    B.5.6E-mailmedinfo.se@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 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 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) 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 Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, UK
    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 nameTrastuzumab
    D.3.4Pharmaceutical form Powder for 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.3.8INN - Proposed INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    locally advanced or metastatic HER2-positive breast cancer, that has progressed after or during at least one Trastuzumab-containing regimen
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast 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 13.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast 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
    Primary objective of phase Ib: Define the maximum tolerated dose (MTD) and/or the recommended phase two dose (RPTD) of AUY922 in combination with Trastuzumab when administered I.V. on a once weekly schedule to adult patients with advanced or metastatic HER2-positive breast cancers.

    Primary objective of phase II: Evaluate preliminary anti-tumor activity of AUY922 in combination with trastuzumab in adult patients with advanced or metastatic HER2- positive breast cancers.
    E.2.2Secondary objectives of the trial
    Secondary objectives of phase Ib:
    •Characterize the safety and tolerability of AUY922 when administered in combination with Trastuzumab.
    •Characterize the pharmacokinetic profile of AUY922 and its metabolite BJP762, when given in combination with Trastuzumab.
    Secondary objectives of phase II:
    •Characterize the safety and tolerability of the combination at the RPTD
    •Assess the efficacy at the RPTD (e.g. Progression Free Survival (PFS), Overall Survival (OS))
    •Characterize the pharmacokinetic profile of AUY922 and its metabolite BJP762, when given in combination with Trastuzumab
    •Evaluate the pharmacodynamic effect of AUY922 and Trastuzumab on HSP90 client proteins in blood and tumor tissue

    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Primary endpoint of phase Ib:
    • Incidence rate of Dose-Limiting Toxicities (DLT)
    Primary endpoint of phase II:
    • Overall response rate (ORR)
    Secondary endpoints of phase II:
    • Safety: Adverse drug reactions and serious adverse drug reactions, changes in hematology and chemistry values, specifically those associated with hepatic and renal function; and assessment of physical examinations, neurological exams, vital signs and electrocardiograms.
    • PFS/OS as defined in RECIST guidelines
    • Pharmacokinetics: Exposure of AUY922 in plasma. PK parameters such as AUC, Cmax, Ctrough and t1/2.
    • Temporal and magnitude changes in blood and tissue of relevant biomarkers levels comparing pre- vs. post-treatment
    E.3Principal inclusion criteria
    • Female pts with confirmed HER2-positive, non-operable locally advanced or metastatic breast cancer. Tumor samples of HER2-positive patients must demonstrate HER2 over-expression based on either: Immunohistochemistry (IHC) at the 3+ level, or IHC 2+ confirmed by fluorescence in-situ hybridization (FISH). Tumors tested by FISH must be positive by the specific FISH assay for the amplification of HER2.
    • Patients must have received at least 1 but no more than 2 prior anti-HER2 based regimens including at least 1 regimen containing Trastuzumab. If recurrence occurred during adjuvant therapy, or ≤ 12 months after completion of adjuvant Trastuzumab-containing therapy, the patient is eligible. In this case the adjuvant therapy will be considered as one line of treatment for advanced disease.
    • Patients must have at least one measurable lesion as defined by RECIST. Irradiated lesions are only evaluable for disease progression.
    • All patients must have documented progressive disease following the last line of therapy before entering the study.
    • Patients who fulfill the following criteria will be eligible for PET assessments:
    - at least one lesion must be measurable ( > 2cm)
    - to be eligible for follow-up scans, patients should have uptake of the tracer in at least one lesion with a tumor-background ratio ≥ 2
    - able to lie still and flat on the table
    • Age ≥ 18 years
    • ECOG Performance Status of ≤ 1
    • Able to sign informed consent and to comply with the protocol
    • Patients must have laboratory values as specified in the protocol
    E.4Principal exclusion criteria
    • Patients with known CNS metastasis which are symptomatic or require treatment for symptom control and/or growing. Note: Patients without clinical signs or symptoms of CNS involvement are not required to have a CT/MRI of the brain
    • Prior treatment with any HSP90 or HDAC inhibitor.
    • Patients who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:
    - Radiotherapy, conventional chemotherapy, hormonotherapy, investigational drugs and monoclonal antibodies other than Trastuzumab: within 4 weeks
    - Palliative radiotherapy: within 2 weeks
    - Nitrosoureas, mitomycin: within 6 weeks
    • Patients with unresolved diarrhea ≥ CTCAE grade 1
    • Patients who have not recovered from the reversible side effects of previous systemic anticancer therapy (except for alopecia) to less than CTCAE grade 2 prior to the first dose.
    • Treatment with therapeutic doses of sodium warfarin (Coumadin). Low doses of Coumadin (e.g. < 2mg/day for line patency) are permitted.
    • Pregnant or lactating women.
    • Fertile women of childbearing potential (WCBP) not using adequate contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
    • Patients with acute or chronic liver or renal disease.
    • Patients with other 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) that could cause unacceptable safety risks or compromise compliance with the protocol.
    • Known hypersensitivity to any study medication.
    • Impaired cardiac function
    • Patients unwilling or unable to comply with the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of phase Ib:
    • Incidence rate of Dose-Limiting Toxicities (DLT)

    Primary endpoint of phase II:
    •Overall response rate (ORR)
    Secondary endpoints of phase II:
    • Safety: Adverse drug reactions and serious adverse drug reactions, changes in hematology and chemistry values, specifically those associated with hepatic and renal function; and assessment of physical examinations, neurological exams, vital signs and electrocardiograms.
    •PFS/OS as defined in RECIST guidelines
    • Pharmacokinetics: Exposure of AUY922 in plasma. PK parameters such as AUC, Cmax, Ctrough and t1/2
    • Temporal and magnitude changes in blood and tissue of relevant biomarkers levels comparing pre- vs. post-treatment
    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 Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    MTD / recommended phase 2 dose of combination AUY922 / Herceptin
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    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 years2
    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 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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 52
    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 Decision2010-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-11
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