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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2006-001354-28
    Sponsor's Protocol Code Number:D4200C00068
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-13
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-001354-28
    A.3Full title of the trial
    A Phase II, open-label study to assess the efficacy and tolerability of ZD6474 ZACTIMA 100 mg monotherapy in subjects with locally advanced or metastatic hereditary medullary thyroid cancer
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberD4200C00068
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorASTRAZENECA
    B.1.3.4CountryItaly
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/334
    D.3 Description of the IMP
    D.3.1Product nameZACTIMA
    D.3.2Product code ZD6474
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeZD6474
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 hereditary medullary thyroid 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 10027105
    E.1.2Term Medullary thyroid cancer
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the objective response rate in subjects treated with ZD6474 ZACTIMA 100 mg monotherapy.
    E.2.2Secondary objectives of the trial
    1.To determine the safety and tolerability of ZD6474 treatment in this patient population 2.To determine progression free survival PFS of hereditary MTC in subjects following ZD6474 100 mg therapy 3.To determine the disease control rate DCR , duration of objective response DOR and duration of disease control with ZD6474 4.To assess the change in performance status PS from baseline of subjects given ZD6474 using World Heath Organization WHO PS 5.To determine whether treatment with ZD6474 results in a decrease of stool frequency in subjects with symptomatic diarrhea associated with hereditary MTC symptomatic response 6.To assess of the effect of ZD6474 100 mg dose on CTN and CEA levels 7.To characterize the population pharmacokinetic PK of ZD6474 in subjects with hereditary MTC 8.To characterize the pharmacokinetic-pharmacodynamic PK-PD relationship between ZD6474 exposure and changes in QTc prolongation, adverse events AEs , response, PFS, and change
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Provision of written informed consent 2.Female or male aged 18 years and over 3.Previously confirmed histological diagnosis of locally advanced or metastatic hereditary medullary thyroid carcinoma without standard therapeutic options for treatment. Documentation must be provided in the subject s medical chart. 4.Life expectancy of 12 weeks or longer 5.WHO Performance status 0-2 6.One or more measurable lesions at least 10 mm in the longest diameter by spiral CT scan 5 mm slice thickness or 20 mm with conventional techniques 5 mm slice thickness according to modified RECIST criteria 7.Negative pregnancy test for women of childbearing potential. Female subjects must be one year postmenopausal, surgically sterile, or using an acceptable method of contraception. Male subjects must be surgically sterile or using an acceptable method of contraception during their participation in this study
    E.4Principal exclusion criteria
    1.Brain metastases or spinal cord compression, unless irradiated at least 4 weeks before first dose and stable without steroid treatment for 1 week 2.The last dose of prior chemotherapy is received less than 4 weeks before the start of study therapy 3.Radiation therapy within the last 4 weeks before the start of study therapy. 4.Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy 5.Any unresolved toxicity greater than CTCAE grade 2 from previous anti-cancer therapy 6.Serum bilirubin greater than 1.5 x ULRR 7.Serum creatinine greater than 1.5 x ULRR or creatinine clearance 8804;50 ml/min calculated by Cockcroft-Gault formula 8.Alanine aminotransferase ALT , aspartate aminotransferase AST , or alkaline phosphatase ALP 2.5 x ULRR if no demonstrable liver mets, or 5 x ULRR if judged by the Investigator to be related to liver metastases 9.Significant cardiac event eg. myocardial infarction, super vena cava SVC syndrome, New York Heart Association NYHA classification of heart disease 8805;2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia 10.History of arrhythmia multifocal premature ventricular contractions PVC s , bigeminy, trigeminy, ventricular tachycardia, symptomatic or uncontrolled atrial fibrillation which is symptomatic or requires treatment CTCAE grade 3 or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted. 11.Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age 12.QT prolongation with other medications that required discontinuation of that medication 13.Presence of left bundle branch block LBBB 14.QTc with Bazett s correction unmeasurable or 8805; 480 msec or greater on screening ECG. Note If a subject has QTc 8805;480 msec on screening ECG, the screen ECG may be repeated twice . One ECG, or the mean, if more than one are performed, must have a QTc value of 480 msec in order for the patient to be eligible for the study. 15.Potassium 4.0 mmol/L despite supplementation; serum calcium or ionized or adjusted for albumin , or magnesium out of normal range despite supplementation 16.Pregnancy or breast feeding women of child-bearing potential 17.Any concomitant medications that may affect QTc or induce CYP3A4 function with the exception of somatostatin or somatostatin analog and / or prohibited medications referenced in Appendix E and Section 3.8 18.HTN not controlled by medical therapy systolic blood pressure greater than 160 millimeter of mercury mmHg or diastolic blood pressure greater than 100 mmHg 19.Previous or current malignancies at other sites within last 5 years, with the exception of in situ carcinoma of the cervix and adequately treated basal cell or squamous cell carcinoma of the skin 20.Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol 21.Previous enrollment in the present study or previous enrollment on study with treatment using ZD6474
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to determine the objective response rate in subjects treated with ZD6474 ZACTIMA 100 mg monotherapy
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 No
    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) 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-04-13. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 7
    F.4.2.2In the whole clinical trial 15
    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 Decision2007-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-20
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 16:47:42 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA