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    Summary
    EudraCT Number:2007-002725-74
    Sponsor's Protocol Code Number:COU-AA-004
    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:2007-05-30
    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 number2007-002725-74
    A.3Full title of the trial
    A Phase II Open Label Study of CB7630 (Abiraterone Acetate) and Prednisone in
    Patients with Advanced Prostate Cancer Who Have Failed Androgen Deprivation and
    Docetaxel-Based Chemotherapy
    A.4.1Sponsor's protocol code numberCOU-AA-004
    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 SponsorCougar Biotechnology, 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 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 nameAbiraterone acetate
    D.3.2Product code CB7630
    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.3.9.2Current sponsor codeCB7630
    D.3.9.3Other descriptive nameabiraterone acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    HRPC (Hormone refractory prostate cancer) refractory to androgen deprivation and Docetaxel based chemotherapy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory prostate cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The proportion of patients achieving a PSA decline of >50% (PSA
    response) according to Prostate-Specific Antigen Working Group
    (PSAWG) criteria
    E.2.2Secondary objectives of the trial
    The safety and tolerability of CB7630, with concurrent prednisone, in the
    study population

    PSA-based progression-free survival (PSA-PFS)

    Radiographic progression-free survival (RAD-PFS)

    Overall survival

    Objective radiographic response rate (RAD-ORR) in patients with
    measurable lesions using RECIST

    Duration of PSA decline >50% and objective response (PSA-ORR), if
    applicable

    Clinical benefit, as determined by disease stabilization and change in
    patient ECOG performance status
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide written informed consent

    2. Written Data Protection Consent has been obtained

    3. Age ≥ 18 years and male

    4. Histologically or cytologically confirmed adenocarcinoma of the prostate, but
    not with neuroendocrine differentiation or of small cell histology

    5. Prior chemotherapy for prostate cancer with regimen(s) containing docetaxel.
    Patients may have had up to two previous chemotherapy regimens

    6. Documented PSA progression according to PSAWG eligibility criteria
    (Attachment 1) with a PSA> 5 ng/mL

    7. On-going androgen deprivation with serum testosterone < 50 ng/dL (<
    2.0nM)

    8. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
    (Karnofsky Performance Status ≥ 50%)

    9. Any acute toxicities of prior chemotherapy, radiotherapy have resolved to a
    NCI CTCAE (version 3) grade of ≤ 1. Chemotherapy induced alopecia and
    grade 2 neuropathy are excluded from this consideration

    10. Life expectancy > 12 weeks

    11. Able to swallow the CB7630 whole as a tablet

    12. Able to follow study instructions, accessible for treatment and follow-up, and
    likely to complete all study requirements
    E.4Principal exclusion criteria
    1. Active or uncontrolled autoimmune disease that may require corticosteroid
    therapy

    2. Serious or uncontrolled co-existent non-malignant disease, including active and
    uncontrolled infection

    3. Uncontrolled hypertension

    4. Hemoglobin ≤ 9.0 g/dL without growth factor or transfusion support

    5. Abnormal liver function tests consisting of any of the following:
    Serum bilirubin > 1.5 x ULN
    ALT > 2.5 x ULN
    AST > 2.5 x ULN

    6. Serum creatinine > 2.0 x UNL or a calculated creatinine clearance < 50 mL/min

    7. Serum potassium < 3.5 mmol/L

    8. Clinically significant heart disease as evidenced by a myocardial infarction in the
    past twelve months, severe or unstable angina, or New York Heart Association
    (NYHA) Class III or IV heart disease. Patients with a history of atherosclerotic
    vascular disease requiring coronary or peripheral artery bypass surgery may be
    enrolled provided the surgery occurred at least two years prior to enrollment and
    after consultation with a cardiologist to insure that the disease is stable

    9. Abnormal electrocardiogram, including any finding which would interfere with
    assessment of intervals (patients with long QT syndrome, bundle branch blocks
    or hemiblocks are prohibited)

    10. Malignancy within the previous 5-years other than basal cell or squamous cell
    carcinomas of skin with a >30% probability of recurrence within 12 months

    11. History of adrenal insufficiency or hyperaldosteronism

    12. History of gastrointestinal disorders (medical disorders or extensive surgery)
    which may interfere with the absorption of the study medication

    13. Radiotherapy, chemotherapy or immunotherapy within 30 days of administration
    of the Cycle 1 Day 1. Supportive care with glucocorticoid is not considered as an
    immunotherapy; however, PSA progression must be documented under current
    dose/regimen

    14. Surgery or local prostatic intervention within 30 days of the first dose In
    addition, any clinically relevant sequelae from the surgery must have resolved
    prior to Cycle 1 Day 1

    15. Current enrollment in an investigational drug or device study or participation in
    such a study within 30 days of Cycle 1 Day 1

    16. Initiate bisphosphonate therapy or adjust bisphosphonate dose/regimen within 30 days of Cycle 1 Day 1

    17. Condition or situation which, in the investigator’s opinion, may put the patient at
    significant risk, may confound the study results, or may interfere significantly
    with patient’s participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate anti-tumor effects and safety of CB7630 in patients with
    advanced prostate cancer who have failed androgen deprivation and
    docetaxel-based chemotherapy

    The proportion of patients achieving a PSA decline >50% (PSA response)
    according to Prostate-Specific Antigen Working Group (PSAWG) criteria

    Efficacy measures:

    • Serum PSA decline evaluation according to PSAWG criteria. (Attachment 1)

    • Tumor measurements and response evaluation (RAD-ORR) using RECIST
    Criteria for patients with measurable disease (Attachment 2)

    • PSA based progression free survival (PSA-PFS)

    • Radiographic progression free survival (RAD-PFS)

    • Overall survival

    Safety measures:

    • Adverse events including laboratory adverse events will be graded and
    summarized according to the National Cancer Institute Common Terminology
    Criteria for Adverse Events (CTCAE), version 3 (Attachment 3).

    • ECGs (triplicate)

    • Laboratory tests (CBC with differential, platelets, Chemistry, UA)

    • Vitals signs, including oral temperature, upright and supine blood pressure, heart
    rate, respiratory rate and weight)

    • Physical examination

    • Chest X-ray
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Completion of dosing with 12 cycles of abiraterone acetate or early termination. If the final patient has an ongoing AE related to protocol treatment, the trial will end when the AE is resolved.

    Patients benefiting from study will be offered the opportunity to continue treatment with CB7630 in a separate study at the end of cycle 12.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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 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 No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state27
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 27
    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)
    Details in protocol
    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 Decision2007-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-17
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