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    Summary
    EudraCT Number:2007-001890-27
    Sponsor's Protocol Code Number:D4200C00079
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-23
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2007-001890-27
    A.3Full title of the trial
    A Randomized, Double Blind, placebo-controlled Phase II, Multi-Centre Study to Assess the Efficacy and Safety of Zactima™ in Patients with locally advanced or metastatic papillary or follicular Thyroid Carcinoma failing or unsuitable for Radioiodine therapy
    A.4.1Sponsor's protocol code numberD4200C00079
    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 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 nameZACTIMA
    D.3.2Product code ZD6474
    D.3.4Pharmaceutical form 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 INNvandetanib
    D.3.9.1CAS number 443913-73-3
    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 number300
    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.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
    Locally advanced or metastatic papillary or follicular Thyroid Carcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001205
    E.1.2Term Adenocarcinoma thyroid
    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 demonstrate an improvement in progression free survival (PFS) with ZACTIMA™ (ZD6474) 300 mg as compared to Placebo in subjects with locally advanced or metastatic papillary or follicular Thyroid Carcinoma failing or unsuitable for Radioiodine therapy
    E.2.2Secondary objectives of the trial
    1. To demonstrate an improvement in Disease Control Rate (DCR) [Complete Response (CR) + Partial Response (PR) + Stable disease (SD) at 6 months] with ZACTIMA™ (ZD6474) 300 mg as compared to placebo according to the RECIST (Therasse et al, 2000).
    2. To quantify the improvement in Objective Response Rate (ORR) (CR+PR) with ZACTIMA™ (ZD6474) 300 mg as compared to placebo according to the RECIST.
    3. To demonstrate an improvement in the Overall Survival (OS) with ZACTIMA™ (ZD6474) as compared to placebo.
    4. To determine the safety and tolerability of ZACTIMA™ (ZD6474) 300 mg in subjects with locally advanced or metastatic papillary or follicular Thyroid Carcinoma failing or unsuitable for Radioiodine therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent prior to any study-related procedures.
    2. Female or male aged 18 years and over.
    3. Previously confirmed histological diagnosis of advanced or metastatic papillary or follicular thyroid carcinoma, without anaplastic component. Tumor sample available for centralized exploratory analysis.
    4. Presence of a measurable tumour as defined by:
    (a) A solitary measurable lesion: For conventional CT scanners, the minimum-sized for the lesion should be ≥20 mm using effective slice thicknesses ≥ 5mm, or for spiral (helical) CT scanners, the minimum size of solitary lesion at baseline should be ≥ 10 mm using effective slice thicknesses.
    (b) For multiple lesions, a sum of diameter 20 mm (with no target lesion measuring < 10 mm using effective slice thicknesses ≤ 5 mm), or for multiple lesions, a sum of diameter > 30 mm (with no target lesion measuring < 15 mm using effective slice thicknesses > 5 mm).
    5. Life expectancy of 12 weeks or longer.
    6. WHO Performance status 0-2.
    7. Able to swallow study medication.
    8. Progressive disease following RAI131 or patient unsuitable for RAI131 after surgery.
    9. Serum TSH below normal reference range.
    10. Negative pregnancy test for female subjects of childbearing potential.
    E.4Principal exclusion criteria
    1. Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days.
    2. Major surgery within 4 weeks before randomization.
    3. Prior chemotherapy within the last 4 weeks prior to randomization.
    4. RAI131 therapy within 3 months in patients with radioiodine uptake.
    5. Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy).
    6. Serum bilirubin >1.5 x the upper limit of reference range (ULRR).
    7. Creatinine clearance <30 ml/minute (calculated by Cockcroft-Gault formula).
    8. Potassium below normal reference range despite supplementation; or above the CTCAE grade 1 upper limit.
    9. Magnesium below the normal range despite supplementation or above the CTCAE grade 1 upper limit.
    10. Serum calcium above the CTCAE grade 1 upper limit.
    11. In cases where the serum calcium is below the normal range:
    - the calcium adjusted for albumin is to be obtained and substituted for the measured serum value. Exclusion is to then be based on the calcium adjusted for albumin values decreasing below the normal limit. Corrected Calcium=Ca + 0.8 X (4-serum albumin)
    12. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5 × ULRR, or greater than 5.0 × ULRR if judged by the investigator to be related to liver metastases.
    13. Clinically significant cardiovascular event (eg myocardial infarction), superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart failure >II within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
    14. History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, which is symptomatic or requires treatment (CTCAE grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
    15. Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
    16. QT prolongation with other medications that required discontinuation of that medication.
    17. Presence of left bundle branch block (LBBB).
    18. QTc with Bazett’s correction unmeasurable or >480 msec on screening ECG (Note: If a subject has QTc interval >480 msec on screening ECG, the screen ECG may be repeated 2 times [at least 24 hours apart]. The average QTc from the three screening ECGs must be <480 msec in order for the subject to be eligible for the study). Patients who are receiving a drug that has a risk of QTc prolongation (see Appendix E for list of medications) are excluded if QTc is ≥ 460 msec.
    19. Hypertension not controlled by medical therapy (systolic BP greater than 160 millimeter of mercury [mmHg] or diastolic blood pressure greater than 100 mmHg).
    20. Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes (see Appendix E for the lists of medications in Table 1 & Table 2) or induce CYP3A4 function.
    21. Currently active diarrhea that may affect the ability of the patient to absorb the ZACTIMA or tolerate diarrhea.
    22. Previous or current malignancies of other histologies within the 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.
    23. Any unresolved chronic toxicity greater than CTCAE grade 1 from previous anticancer therapy.
    24. Participation in a clinical study and/or receipt of an investigational drug during the last 30 days (participation in the survival follow-up period of a study is not an exclusion).
    25. Evidence of severe or uncontrolled systemic disease (hepatitis B or HIV infection) 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.
    26. Previous exposure to ZACTIMA (ZD6474).
    27. Currently pregnant or breast feeding.
    28. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site).
    29. Previous randomization or treatment in the present study.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival
    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 Yes
    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 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 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 Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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 months6
    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 months6
    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.1.1.1In 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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 135
    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 Decision2007-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-01
    P. End of Trial
    P.End of Trial StatusCompleted
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