Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39817   clinical trials with a EudraCT protocol, of which   6534   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-023854-35
    Sponsor's Protocol Code Number:CD-ON-MEDI-575-1031
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-16
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-023854-35
    A.3Full title of the trial
    A Phase 1b/2 Randomized Study of MEDI-575 in Combination With Carboplatin Plus Paclitaxel Versus Carboplatin Plus Paclitaxel Alone in Adult Subjects With Previously Untreated, Advanced Non-Small Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Adults with Advanced, Untreated, Non-Small Cell Lung Cancer With Either MEDI-575 or MEDI-575 Plus Carboplatin and Paclitaxel
    A.4.1Sponsor's protocol code numberCD-ON-MEDI-575-1031
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01268059
    A.5.4Other Identifiers
    Name:AZD8813Number:AAB7.2
    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 SponsorMedImmune, LLC
    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 supportMedImmune, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune
    B.5.2Functional name of contact pointinformation Center
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrialenquiries@medimmune.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 nameMEDI-575
    D.3.2Product code MEDI-575
    D.3.4Pharmaceutical form 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 INNMEDI-575
    D.3.9.1CAS number 1243266-0407
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameAAB7.2 and AZD8813
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    Previously untreated advanced non-small cell lung cancer in adults
    E.1.1.1Medical condition in easily understood language
    Previously untreated advanced non-small cell lung cancer in adults
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    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 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    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
    Evaluation of progression-free survival of subjects following treatment with MEDI-575 when used in combination with paclitaxel/carboplatin versus paclitaxel/carboplatin alone in subjects with previously untreated, advanced non-small cell lung cancer
    E.2.2Secondary objectives of the trial
    Five secondary objectives:
    1. To evaluate other antitumor activities of MEDI-575 when used in combination with paclitaxel/carboplatin
    2. To describe the safety and tolerability of MEDI-575 when used in combination with carboplatin/paclitaxel
    3. To determine the immunogenicity of MEDI-575
    4. To describe the pharmacokinetics of MEDI-575 in combination with paclitaxel/carboplatin
    5. To determine the expression of platelet-derived growth factor alpha in the tumor cells and stroma of archived tumor samples.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all the following criteria:
    Age 18 years or older at the time of screening,
    Written informed consent and any locally required authorization,
    Histologically confirmed inoperable Stage IIIB or Stage IV non-small cell lung cancer (squamous cell carcinoma only)
    ECOG performance status of 0 or 1,
    Life expectancy of ≥ 3 months,
    Prothrombin time elevation ≤ Grade 2 is acceptable for subjects on anticoagulant therapy,
    Adequate hematologic and organ function,
    Suitable candidates for therapy with carboplatin/paclitaxel,
    Subjects must have at least 1 lesion that is measurable using RECIST,
    Subjects must be willing to consent to allow collection of archived NSCLC tumor samples,
    Adequate contraception from screening through end of trial
    Normal potassium and magnesium levels at baseline
    E.4Principal exclusion criteria
    Any of the following would exclude the subject from participation in the study:
    Concurrent enrollment in another clinical study,
    Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals,
    Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for treatment of cancer,
    Previous monoclonal antibody treatment,
    History of serious allergy or reaction to any component of the MEDI-575 formulation,
    Receipt of any previous anticancer therapies,
    (Previous adjuvant/neoadjuvant radiotherapy or chemotherapy is allowed)
    New York Heart Association ≥ Class II congestive heart failure,
    History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to enrollment,
    History of other invasive malignancy within 5 years,
    Use of immunosuppressive medication within 7 days prior to enrollment,
    Systemic immunosuppressive steroid therapy,
    History of active human immunodeficiency virus (HIV) or active hepatitis
    virus infection (HBV,HCV),
    Clinically significant abnormality on ECG,
    Pregnant or lactating
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for efficacy is PFS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured from randomization until the documentation of disease progression or death due to any cause, whichever occurs first, based on imaging review of response and disease progression. Imaging to occur at baseline then every 2 cycles (ie, every 6 weeks) beginning with cycle 3
    E.5.2Secondary end point(s)
    Assessment of antitumor activity:
    •ORR, TTR, DR, TTP, OS, and change in tumor size.
    Safety endpoints:
    •Collection of AEs and SAEs. Also, changes in clinical laboratory, and ECG evaluations from baseline
    Immunogenicity:
    •By summarizing number and percentage of subjects who develop detectable anti-MEDI-575 antibodies
    PK Assessment:
    •Assessed using parameters including Cmax, Tmax, and AUCĪ„ after the first dose. MEDI-575 steady state PK parameters include Cmaxss, Cminss, and Tmaxss
    Expression of PDGFRalpha:
    •Determination of expression of PDGFRalpha in tumor tissue
    E.5.2.1Timepoint(s) of evaluation of this end point
    Antitumor activity:
    •OS determined as time from randomization until death due to any cause. ORR, TTR, DR, TTP, and change in tumor size will be assessed based on imaging review of response and progression.
    Safety endpoints:
    •AEs and SAEs occurring from time written IC is obtained continuously through 90 days post last dose or until subject begins another anticancer therapy. Changes from baseline in clinical laboratory and ECG evaluations will be assessed from results collected on study visits.
    Immunogenicity:
    •Assessed prior to infusion on Day 1 of each cycle as well as at the EOT and during follow up.
    PK:
    •Each study visit day throughout all cycles.
    Expression of PDGFRalpha:
    •Archived tissue will be collected prior to Day1 of the first cycle for expression analysis
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 No
    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
    Japan
    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
    The end of the study (“study completion”) is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last subject in the study. This date will be 14 months after the last subject is entered into the trial or when the sponsor stops the study.
    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 months2
    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 months2
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 112
    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)
    Post-study treatment will be at the discretion of the investigator.
    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 Decision2012-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-04
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA