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    Summary
    EudraCT Number:2005-004941-33
    Sponsor's Protocol Code Number:A6191007
    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:2006-04-10
    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 number2005-004941-33
    A.3Full title of the trial
    A PHASE 2 STUDY OF THE EFFICACY AND SAFETY OF SU-014813 IN PATIENTS WITH METASTATIC BREAST CANCER
    A.4.1Sponsor's protocol code numberA6191007
    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 SponsorPFIZER Inc
    B.1.3.4CountryUnited States
    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 nameSU-014813
    D.3.2Product code SU-014813
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeSU-014813
    D.3.9.3Other descriptive namePHA-571436F
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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
    Histologically or cytological proven diagonis of metastatic breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10055113
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the antitumor efficacy of single agent SU-014813 at a dose of 100 mg orally once daily in patients with metastatic breast cancer
    E.2.2Secondary objectives of the trial
    - To assess onset and duration of tumor control and 1-year survival rate
    - To evaluate the safety of SU-014813
    - To assess patient reported outcomes
    - To determine SU-014813 plasma trough concentration (Ctrough) and to explore
    the relationship between Ctrough and efficacy, safety, and biomarkers
    - To explore the correlations of cancer biomarkers with treatment-related outcomes
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Histologically or cytologically proven diagnosis of metastatic breast
    adenocarcinoma that is not amenable to surgery, radiation, or combined modality
    therapy with curative intent.
    2. Must have received prior treatment with an anthracycline and a taxane either
    concurrently or sequentially in the adjuvant and/or advanced disease treatment
    settings. Patients whose tumors are Her-2-positive must have received prior
    trastuzumab therapy.Patients may have received as many as 2 other
    chemotherapy regimens in the advanced disease setting.
    Prior hormonal therapy or immunotherapy in the adjuvant and/or
    advanced/metastatic disease settings is permitted.
    Prior treatment with surgery, radiotherapy, chemoembolization
    therapy, or cryotherapy is allowed if these therapies did not affect the areas of
    measurable disease.
    3. If patient has only received treatment in the adjuvant setting, patient must have
    experienced relapse or progression of disease during treatment or within 12
    months of the last dose of adjuvant therapy.
    4. Completion of all prior chemotherapy, and radiotherapy more than/or 3 weeks
    prior to study entry, and resolution of all acute toxic effects of any prior cytokine
    therapy, radiotherapy, or surgical procedure to National Cancer Institute (NCI)
    Common Terminology Criteria for Adverse Events (version 3.0) grade less
    than/equal to grade 1.
    5. Patients on bisphosphonate therapy for metastatic bone disease must have
    initiated therapy >3 months prior to study entry.
    6. Evidence of unidimensionally measurable disease according to RECIST criteria.
    7. Female
    8. Eighteen years of age or older.
    9. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
    10. Adequate organ function as defined by the following criteria:
    • Serum aspartate aminotransferase (AST; serum glutamate-oxalate
    transferase [SGOT]) and serum alanine aminotransferase (ALT; serum
    glutamate-pyruvate transferase [SGPT]) less than/equal to 2.5 x laboratory
    upper limit of normal (ULN). If liver function abnormalities are due to
    underlying malignancy, then AST and ALT may be less than/equal to
    5 x CL-ULN
    • Total serum bilirubin less than /equal to 1.5 x ULN
    • Prothrombin time (PT) and partial thromboplastin time (PTT) less
    than /equal to 1.5 x ULN
    • Serum albumin ≥3.0 g/dL
    • Absolute neutrophil count (ANC) ≥1500 mm3
    • Platelets ≥ 100,000 mm3
    • Hemoglobin ≥ 9.0 g/dL
    • Serum creatinine less than/equal to 1.5 x ULN

    11. Willingness and ability to comply with scheduled visits, treatment plans,
    laboratory tests, and other study procedures.
    12. Signed and dated informed consent document indicating that the patient has
    been informed of all pertinent aspects of he trial prior to enrollment.
    E.4Principal exclusion criteria
    1. Prior treatment with ≥3 regimens of chemotherapy in the metastatic disease
    setting beyond those containing anthracyclines and taxanes.
    2. Prior treatment with any tyrosine kinase inhibitors, VEGF inhibitors, or other
    angiogenic inhibitors.
    3. Previous high-dose chemotherapy requiring hematopoietic stem cell rescue.
    4. Prior radiation therapy to >25% of the bone marrow.
    5. Current treatment on another clinical trial.
    6. Uncontrolled brain metastases, spinal cord compression, or carcinomatous
    meningitis, or new evidence of brain or leptomeningeal disease. Patients should
    have completed surgery or radiation therapy for existing brain metastases,
    should not have documented increase in size over the previous 3 months and
    should be asymptomatic.
    7. Diagnosis of any second non-breast malignancy within the last 5 years, except
    for adequately treated basal cell carcinoma or for in situ carcinoma of the cervix
    uteri.
    8. Any of the following within the 12 months prior to study drug administration:
    severe/unstable angina, symptomatic congestive heart failure, or
    cerebrovascular accident including ischemic attack or pulmonary embolism.
    9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency
    syndrome (AIDS)-related illness.
    10. Presence of malabsorption due to prior surgery, gastrointestinal disease or for
    an unknown reason, or inability to take oral medication. Patients may have had
    major GI surgery but must not have residual symptomatic manifestation of
    malabsorption.
    11. Pregnancy or breast-feeding. Patients must be surgically sterile or be
    postmenopausal, or must agree to use effective contraception during the period
    of therapy. All patients with reproductive potential must have a negative
    pregnancy test prior to study treatment . The definition of effective
    contraception will be based on the judgment of the principal investigator or a
    designated associate.
    12. Other severe acute or chronic medical or psychiatric condition, or laboratory
    abnormality that may increase the risk associated with study participation or
    study drug administration, or may interfere with the interpretation of study
    results, and in the judgment of the investigator would make the patient
    inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Overall confirmed objective response rate (ORR), defined as the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (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 Yes
    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 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 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 No
    E.8.1.1Randomised No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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) Information not present in EudraCT
    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 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 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 2006-04-10. 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 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 70
    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)
    After completion of the study patients with clinical benefit as judged by the investigator and upon discussion with the sponsor will be candidates for continuation of treatment beyond 6 months .
    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 Decision2006-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-02-19
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