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    The EU Clinical Trials Register currently displays   39818   clinical trials with a EudraCT protocol, of which   6535   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-000358-21
    Sponsor's Protocol Code Number:D7919C00706 (ZD1839IL/0706)
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-08-31
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2004-000358-21
    A.3Full title of the trial
    A Phase II Randomised, Double-blind, Placebo-controlled, Multicentre Comparative study of ZD1839 250 mg or 500 mg (Iressatm) given either continuously or concomitantly with cisplatin plus radiotherapy for the treatment of patients with previously untreated unresected late stage III/IV non-metastatic head and neck squamous cell carcinoma
    A.4.1Sponsor's protocol code numberD7919C00706 (ZD1839IL/0706)
    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 AB
    B.1.3.4CountrySweden
    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 Information not present in EudraCT
    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 nameIressa (gefitinib)
    D.3.2Product code ZD1839
    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.3.8INN - Proposed INNgefitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Untreated, unresected late stage III/IV non-metastatic head and neck squamous cell carcinoma
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess the additive effect of ZD1839 250 mg and ZD1839 500 mg (given either concomitantly or as maintenance) over cisplatin plus radiotherapy (RT) in terms of local disease control (progression-free) rate at 2 years.
    E.2.2Secondary objectives of the trial
    Comparing ZD1839 250 mg and ZD1839 500 mg or placebo:

    1. used continuously (concomitantly and for maintenance) with cisplatin plus radiotherapy (RT) in terms of local disease control (progression-free) rate at 2 years.
    2. used either concomitantly alone or continuously with cisplatin plus radiotherapy (RT) in terms of local disease control (progression-free) rate at 1 year.
    3. used either concomitantly alone or continuously with cisplatin plus radiotherapy (RT) in terms of complete response (CR).
    4. used either concomitantly alone or continuously with cisplatin plus radiotherapy (RT) in terms of progression-free survival (PFS).
    5. used either concomitantly alone or continuously with cisplatin plus radiotherapy (RT) in terms of safety & tolerability.
    6. used either concomitantly alone or continuously with cisplatin plus radiotherapy (RT) in terms of overall survival.
    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 patients aged 18 years and over
    3. Patients must have measurable disease according to RECIST
    4. Presence of stage III or IVA (Appendix L) squamous cell carcinoma of the head and neck confirmed histologically by biopsy or by fine needle aspiration at the time of diagnosis
    5. No previous surgery to the tumour except for biopsy and not scheduled for surgery
    6. No previous chemotherapy or radiotherapy for any neoplasm/tumour
    7. No previous anti-EGFR therapy
    8. Life expectancy ³12 weeks.
    9. World Health Organisation (WHO) Performance Status of 0 or 1
    E.4Principal exclusion criteria
    1. Buccal mucosal carcinomas and post-nasal space (nasopharyngeal carcinoma), thyroid, sinus or salivary gland tumours and Grade III laryngeal carcinoma
    2. Early stage III cancers (T1N1 or T2N1), Extensive disease (T4b) or metastatic disease (M1)
    3. Disease invading the mandible
    4. The presence of simultaneous primary tumours
    5. Known severe hypersensitivity to ZD1839 or any of the excipients of this product
    6. Known severe hypersensitivity to cisplatin or any of the excipients of this product
    7. Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
    8. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
    9. Absolute neutrophil counts (ANC) £1.0 x 109/litre (L) or platelets £100 x 109/L
    10. Serum bilirubin ³3 times the upper limit of the reference range (ULRR)
    11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the ULRR
    12. Calculated creatinine clearance (Cockcroft and Gault) £60 ml/min
    13. Serum calcium above the ULRR
    14. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
    15. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
    16. Pregnancy or breastfeeding.
    17. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, amifostine, erythropoietin or St. John’s Wort
    18. Concomitant use of CYP3A4 inhibitors (e.g., itraconazole)
    19. Treatment with a non-approved or investigational drug within 30 days before
    Day 1 of study treatment
    20. Evidence of ototoxicity or other neurotoxicity
    21. Concurrent treatment with other experimental drugs and/or anticancer agents
    E.5 End points
    E.5.1Primary end point(s)
    Two years after the last patient is randomised
    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 No
    E.6.7Pharmacodynamic No
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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
    Study closure is two years after the last patient is randomised
    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
    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) No
    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 2005-08-31. 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 Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 224
    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)
    Long term follow up information for survival will be collected
    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 Decision2004-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
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