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    Summary
    EudraCT Number:2007-007623-40
    Sponsor's Protocol Code Number:D4320C00035
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-18
    Trial 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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2007-007623-40
    A.3Full title of the trial
    A Phase II, Double-blind, Placebo-Controlled, Randomised Study to Assess the Efficacy and Safety of ZD4054 in Combination with Pemetrexed (Alimta®) vs. Pemetrexed Alone in Patients with Non-small Cell Lung Cancer who Have Failed One Prior Platinum-based Chemotherapy Regimen.
    A.4.1Sponsor's protocol code numberD4320C00035
    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 nameZD4054
    D.3.2Product code ZD4054
    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 INNZibotentan
    D.3.9.1CAS number 186497-07-4
    D.3.9.2Current sponsor codeZD4054
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboFilm-coated tablet
    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 Non small cell lung cancer (NSCLC) without predominantly squamous cell histology
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10066490
    E.1.2Term Progression of non small cell lung cancer
    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 survival for the combination of ZD4054 plus pemetrexed compared to pemetrexed alone in patients with locally advanced or metastatic NSCLC without predominantly squamous histology after failure of first line anti-cancer therapy.
    E.2.2Secondary objectives of the trial
    (i) The efficacy of ZD4054 in combination with pemetrexed versus pemetrexed alone for the treatment of patients with NSCLC who have failed first line cancer therapy by the assessment of disease progression. Progression is defined as any of the following:

    - Objective disease progression measured using Response Evaluation Criteria In Solid Tumours (RECIST) and/or clinical progression on or before the Mandatory Tumour Assessment Visit (MTAV)

    - Death from any cause.

    (ii) The safety and tolerability of ZD4054 in combination with pemetrexed for the treatment of NSCLC by review of adverse events and laboratory parameters
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent.
    2. Female or male aged 18 years or older.
    3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC on entry into study, where the histology is not predominantly of squamous type.
    4. Patients requiring treatment that meet one of the following criteria:
    - Have progressed following one prior platinum-based chemotherapy regimen for locally advanced or metastatic disease;
    - Have progressed within 6 months of adjuvant platinum-based chemotherapy.
    5. World Health Organisation (WHO) performance status 0-2.
    6. Life expectancy of > 12 weeks.
    7. Patient suitable for treatment with pemetrexed.
    E.4Principal exclusion criteria
    1. Prior treatment with pemetrexed in the last 12 months.
    2. Prior therapy with an ET receptor antagonist.
    3. Any recent surgery, unhealed surgical incision, severe concomitant medical condition (eg, unstable cardiac, hepatic or renal disease) or significant laboratory finding which, in the Investigator’s opinion, makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the study protocol.
    4. New York Heart Association Stage II, III or IV cardiac failure or myocardial infarction in the 6 months prior to randomisation.
    5. Current or prior malignancy within previous 3 years (other than NSCLC or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix).
    6. Brain metastases or spinal cord compression unless treated and stable off steroids for 1 month.
    7. History of past or current epilepsy, epilepsy syndrome or other seizure disorder.
    8. Uncontrolled superior vena cava syndrome.
    9. Any unresolved toxicity ≥ Common toxicology criteria (CTC) grade 2 from previous anticancer therapy (unless specified elsewhere within these criteria).
    10. Less than 4 weeks since completion of prior radiotherapy to the primary tumour or persistence of any acute radiotherapy toxicity.
    11. Corrected QT interval (QTc) > 470 msec using Bazett’s formula.
    12. Patients with factors that increase risk of QTc prolongation or arrhythmic events such as heart failure, hypokalaemia, family history of long QT syndrome or any concomitant medication known to prolong QTc.
    13. Any of the following laboratory values:
    - Total bilirubin > 1.5 x upper limit of normal (ULN) unless patient has confirmed Gilbert’s syndrome.
    - Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x ULN or alkaline phosphatase (ALP) > 3 x ULN if no demonstrable liver metastases or ALT or AST or ALP > 5 x ULN in the presence of liver metastases.
    - Platelets < 100 x 10 to the power of 9 /L;
    - Haemoglobin < 9 g/dL despite transfusion;
    - Absolute neutrophil count (ANC) < 1.5 x 10 to the power of 9 /L;
    - Creatinine clearance ≤ 50 mL/min determined using either the Cockcroft and Gault equation or with a 24-hour urine collection.
    - Presence of clinically significant blood or protein in urine sample.
    14. Use of drugs that are potent inducers of CYP450 (eg, phenytoin, rifampicin, carbamazepine, phenobarbitone, St John’s Wort) within 2 weeks of randomisation. Dexamethasone, a known inducer of CYP2D6 and CYP3A4, may be used as premedication for pemetrexed.
    15. Use of systemic retinoids within 2 weeks of randomisation.
    16. History of hypersensitivity to active or inactive excipients of any study medication (ZD4054/placebo, polysorbate 80, pemetrexed) or family history of hypersensitivity to ET receptor antagonists.
    17. Pregnancy, breastfeeding or women of child-bearing potential not using an effective method of birth control
    18. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff, staff at the study site or representatives of AstraZeneca).
    19. Previous enrolment or randomisation of treatment in the present study.
    20. Known risk of transmitting human immunodeficiency virus or Hepatitis B or C via infected blood.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable is time to death (TTD).
    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 Information not present in EudraCT
    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 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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    The end of the study will be data cut-off for survival estimated to be 12 months after the last patient is randomised, following which no further data are expected on the clinical database.
    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 months10
    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 months10
    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 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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 64
    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 Decision2008-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-24
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