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    Summary
    EudraCT Number:2008-005557-38
    Sponsor's Protocol Code Number:D4200C00083
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-11
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-005557-38
    A.3Full title of the trial
    Addition of vandetanib to standard therapy (pegliposomal doxorubicin) in patients with recurrent ovarian cancer. A multi-centre, non-randomized, open phase I/randomized phase II study
    A.3.2Name or abbreviated title of the trial where available
    AGO-OVAR 2.13
    A.4.1Sponsor's protocol code numberD4200C00083
    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 GmbH
    B.1.3.4CountryGermany
    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 namevandetanib (Zactima)
    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.3.9.2Current 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ovarian 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 10033128
    E.1.2Term Ovarian 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 evaluate the tolerability and safety of once daily oral Vandetanib 100 mg when added to standard therapy (pegliposomal doxorubicin 50 mg/m2 iv every 4 weeks) compared to standard therapy alone (pegliposomal doxorubicin 50 mg/m2 iv every 4 weeks)
    E.2.2Secondary objectives of the trial
    to evaluate the clinical activity of once daily oral Vandetanib 100 mg when added to standard therapy (pegliposomal doxorubicin 50 mg/m2 iv every 4 weeks) compared to standard therapy alone (pegliposomal doxorubicin 50 mg/m2 iv every 4 weeks)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study subjects must fulfil all of the following criteria.
    1. Provision of informed consent prior to any study specific procedures
    2. Female aged 18 years and over
    3. Histopathologically documented invasive epithelial ovarian carcinoma, cancer of the fallopian tube or the peritoneum refractory to platinum-based chemotherapy or with partially platinum sensitive disease. Platinum-refractory or partially platinum-sensitive patients are defined as those who progressed on or did not respond to first-line platinum-based chemotherapy or who progressed on or did not respond to second-line platinum-based chemotherapy within 12 months after end of therapy. A progression-free-interval of 12 months is defined as time from application of last platinum based chemotherapy + cycle length until first evidence of disease progression.
    4. Planned therapy with pegylated liposomal doxorubicin 50 mg/m² for recurrent platinum-refractory ovarian cancer.
    5. Patients with a progression-free-interval of 6 to 12 months after platinum-based chemotherapy are only eligible if a further course of platinum-based combination chemotherapy is not possible as judged by the investigator(s).
    6. Patients must have received at least one previous platinum- and taxane-based chemotherapy regimen.
    7. Measurable disease according to RECIST criteria or alternatively evaluable disease according to RECIST criteria in combination with CA 125 GCIG criteria (see Appendix I)
    8. Life expectancy of 12 weeks or longer
    9. Performance status ECOG 0-2 (see Appendix H)
    10. Adequate organ function defined as: Leukocytes >3,000/µl, absolute neutrophil count >1,500/µl, platelets >100,000/µl, hemoglobin >10 g/dl, total bilirubin <1,5 x ULRR, AST (SGOT) and ALT (SGPT) <2,5 x ULRR, creatinine <1,5 ULRR or creatinine clearance >50 mL/min (calculated by Cockcroft-Gault-Formula, see Appendix G)
    11. Able to swallow study medication
    12. Negative pregnancy test for female subjects of childbearing potential
    E.4Principal exclusion criteria
    Subjects must not enter the study if any of the following exclusion criteria are fulfilled
    1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    2. Previous randomization of treatment in the present study
    3. 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)
    4. Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
    5. Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes (see Appendix C for the lists of medications in Table 1 and Table 2) or induce CYP3A4 function (see Appendix E and Section 6.5). Drugs listed in Appendix C, Table 2, that in the investigator’s opinion cannot be discontinued, are allowed, but only of the QTc is <460 msec.
    6. Major surgery within 4 weeks before randomization, any planned surgery or any incompletely healed surgical incision.
    7. Any serious non-healing wounds, acute or non-healing ulcers, or bone fractions in the last three months
    8. Treatment with mouse-antibodies in patients with evaluable disease and CA-125 progressive disease in the last 3 months. These patients are only eligible in case of measurable disease according to RECIST or cytological/histological proven relapse
    9. More than two prior lines of chemotherapy
    10. Any chemotherapy or other systemic anti-cancer therapy within four weeks prior to randomization.
    11. Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy)
    12. Potassium <4.0 mmol/L despite supplementation, or above the CTCAE grade 1 upper limit.
    13. Calcium or Magnesium below LLRR.
    14. Significant cardiac event (eg myocardial infarction), superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease ≥2 (see Appendix D), within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia
    15. History of arrhythmia (multifocal premature ventricular contractions, 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.
    16. Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age
    17. QT prolongation with other medications that required discontinuation of that medication
    18. Presence of left bundle branch block (LBBB)
    19. QTc with Bazett’s correction unmeasurable or ≥480 msec or greater on screening ECG (see Figure 2) (Note: If a subject has QTc interval ≥480 msec on screening ECG, the screening ECG may be repeated 2 times [at least 24 hours apart] for a total of 3 ECG’s. The average QTc from the three screening ECG’s must be <480 msec in order for the subject to be eligible for the study.) If a subject is receiving one of the medications that has a risk of QTc prolongation but that has not clearly been associated with possible association with Torsades de Pointes (see Appendix C, Table 2) prior to study entry, and it cannot be discontinued before study treatment, then the screening QTc must be <460 msec.
    20. Active secondary malignancy influencing treatment or prognosis.
    21. Hypertension not controlled by medical therapy (systolic BP greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg)
    22. Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy
    23. Previous exposure to PLD or Vandetanib
    24. History of hypersensitivity to active or inactive excipients of any study medication (vandetanib or PLD)
    25. Currently active diarrhea that may affect the ability of the patient to absorb vandetanib or to receive chemotherapy
    26. Currently pregnant or breast feeding
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in phase I of the trial is the description of the safety and tolerability by means of the incidence and type of adverse events, clinically significant laboratory abnormalities, electrocardiographic (ECG) changes, and vital signs
    The primary endpoint in phase II of the trial is the proportion of patients terminating the study medication prematurely due to toxicities.

    The secondary endpoints in both phases are progression free survival (PFS), overall survival (OS), objective tumour response rate (ORR), and disease stabilisation for ≥ 6 months (Disease Control Rate, DCR)
    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 Yes
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    2 Part study Phase 1 open / phase II randomised
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Add on to standard therapy (pegliposomal doxorubicin)
    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 concerned20
    E.8.5The trial involves multiple Member States No
    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 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 entire study is defined as ”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 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) 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 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 state70
    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 Decision2009-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-29
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