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    The EU Clinical Trials Register currently displays   35488   clinical trials with a EudraCT protocol, of which   5828   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-005325-30
    Sponsor's Protocol Code Number:D8180C00015
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-12
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-005325-30
    A.3Full title of the trial
    A Phase II, Double-Blind, Placebo Controlled, Multi-Centre, Randomised Study of AZD0530 in Patients with Advanced Ovarian Cancer Sensitive to Platinum-Based Chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    (OVERT-1)
    A.4.1Sponsor's protocol code numberD8180C00015
    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 nameAZD0530
    D.3.2Product code AZD0530
    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.3.9.1CAS number 379231-04-6
    D.3.9.2Current sponsor codeAZD0530
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 379231-04-6
    D.3.9.2Current sponsor codeAZD0530
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    advanced ovarian cancer sensitive to platinum based chemotherapy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLT
    E.1.2Classification code 10033129
    E.1.2Term Ovarian neoplasms malignant (excl germ cell)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the objective tumour response rate, as evaluated according to RECIST guidelines, in patients treated with AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone
    E.2.2Secondary objectives of the trial
    1. To investigate the safety and tolerability of AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone. 2. To compare progression-free survival in patients treated with AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone. 3. To investigate the steady-state pharmacokinetics (PK) of AZD0530 and the N desmethyl metabolite (M594347) in combination with carboplatin plus paclitaxel. 4. To measure plasma concentrations of total platinum 24 hours after administration of carboplatin to enable the estimation of carboplatin AUC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed, written informed consent 2. Females aged 18 years and older 3. Histologically proven diagnosis of: - Epithelial ovarian carcinoma - Fallopian tube carcinoma - Primary serous peritoneal carcinoma 4. Advanced disease not amenable to curative surgery or radiotherapy at the time of study entry 5. Radiological evidence of disease recurrence or progression at least 6 months following treatment cessation of first or second line platinum containing therapy (including platinum based maintenance therapy) 6. Documented non-measurable or measurable lesion according to RECIST criteria assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) 7. World Health Organisation (WHO) performance status 0 to 2 8. Estimated life expectancy of more than 12 weeks 9. Evidence of non-childbearing status: negative pregnancy test within 7 days of study treatment if of childbearing potential, or postmenopausal status (defined by any one of the following: natural menopause with last menses >1 year ago; radiation-induced oophorectomy with last menses >1 year ago, chemotherapy-induced menopause with >1 year interval since last menses) or surgical sterilisation (bilateral oophorectomy or hysterectomy) 10. For inclusion in the optional pharmacogenetic research, patients must fulfil the following criterion: Provision of informed consent for pharmacogenetic research If a patient declines to participate in the pharmacogenetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in the Clinical Study Protocol, so long as they consent.
    E.4Principal exclusion criteria
    1. Clinical evidence of central nervous system (CNS) metastases 2. Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneaum 3. Tumour of borderline malignancy 4. A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) 5. Inadequate bone marrow reserve as demonstrated either by an absolute neutrophil count <1.5 x 10 to the power of 9/L or platelet count <100 x 10 to the power of 9/L 6. Haemoglobin ≤9 g/dL (5.59 mMol/L) 7. Inadequate liver function as demonstrated by serum bilirubin ≥2 times the upper limits of reference range (ULRR), alanine aminotransferase (ALT), aspartate aminotransferase (AST) or ALP ≥2.5 times the ULRR (ALP ≥5 times the ULRR if judged by the investigator to be related to liver metastases) 8. Patients with estimated GFR</=50ml/min calculated by the Cockroft and Gault formula 9. Last dose of anti-cancer therapy received within 14 days prior to the first dose of treatment with study drug. If insufficient wash-out time has not occurred due to schedule or PK properties, a longer wash-out period will be required according to expected time to anti-tumour effect, or known duration and time to reversibility of drug related AEs, as agreed upon by AstraZeneca and the Investigator 10. Received more than two previous chemotherapy regimens for treatment of ovarian cancer 11. Evidence of uncontrolled systemic conditions (eg, severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol 12. Any other concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol 13. Pregnant or breast-feeding women 14. Unwillingness to use an acceptable method of contraception while on study (for women of child bearing potential) and for three months after cessation of dosing with AZD0530. Post-menopausal status will be considered adequate evidence of non-childbearing potential and is defined as any 1 of the following: natural menopause with last menses >1 year ago, radiation induced oophorectomy with last menses >1 year ago, chemotherapy-induced menopause with >1 year interval since last menses or surgical sterilisation (bilateral oophorectomy or hysterectomy) 15. Unresolved toxicity ≥CTCAE grade 2 from previous anti-cancer therapy except alopecia 16. Symptomatic peripheral neuropathy ≥NCIC-CTC grade II 17. Patients believed to have a known immunodeficiency syndrome 18. Resting ECG with measurable QTc interval of >480 msec at 2 or more time points within a 24 hour period 19. Current use or previous use within specified time period (detailed in CSP Appendix E) of drugs or herbal supplements known to be potent inducers or inhibitors of CYP3A4 20. Known hypersensitivity to AZD0530, its excipients, or drugs in its class 21. Cannot be adequately followed up for the duration of their study participation. 22. Participation in another study with an investigational product within the previous 90 days or participation in a previous clinical study within 30 days prior to study entry 23. Risk (in the investigator’s opinion) of transmitting, through blood or other body fluids, the agents responsible for Acquired Immunodeficiency Syndrome, hepatitis B, or hepatitis C.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to compare the objective tumour response rate in patients treated with AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone, as evaluated by RECIST
    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 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 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Final database lock
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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 No
    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 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 147
    F.4.2.2In the whole clinical trial 200
    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 Decision2007-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-21
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