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    The EU Clinical Trials Register currently displays   42570   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Summary
    EudraCT Number:2005-001166-13
    Sponsor's Protocol Code Number:COU-AA-001
    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:2005-08-31
    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 number2005-001166-13
    A.3Full title of the trial
    A Phase I/II Open Label Study of the 17α-hydroxylase/ C17,20 lyase inhibitor, Abiraterone acetate, in Patients with Prostate Cancer who have failed hormone therapy

    A.4.1Sponsor's protocol code numberCOU-AA-001
    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 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 codeCB7630
    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 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
    Hormone refractory prostate cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Classification code 10062904
    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 safety, tolerability and recommended dose of abiraterone acetate administered orally, by continuous once-daily administration in patients with HRPC.

    To determine the effect of abiraterone acetate on the pituitary-adrenal-gonad endocrine axis and on adrenal hormones by evaluating serum levels of testosterone and its precursors.

    To evaluate the efficacy of abiraterone acetate in HRPC at recommended dose.
    E.2.2Secondary objectives of the trial
    To evaluate the pharmacokinetic profile of abiraterone acetate.

    To estimate duration of PSA/objective tumour response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age >18 years and able to comply with protocol requirements.
    2) Signed informed consent.
    3) Histologically documented adenocarcinoma of the prostate, clinically refractory or resistant to hormone therapy, as documented by progression following at least one hormonal therapy, which must include orchiectomy or ongoing treatment with gonadotropin releasing hormone (GnRH) agonists.
    4) PSA evidence for progressive prostate cancer consists of a PSA level of at least 5 ng/ml which has risen on at least 2 successive occasions, at least 2 weeks apart. If the confirmatory PSA value is less than the screening PSA value, then an additional test for rising PSA will be required to document progression.
    5) Patients who were withdrawn from anti-androgen therapy less than 6 months prior to inclusion in the study require one PSA higher than the last pre-withdrawal PSA or 2 increases in PSA documented after the post-withdrawal nadir ≥ 4 weeks from treatment withdrawal if treated with flutamide and ≥6 weeks if treated with bicalutamide or nilutamide. Patients with progression of measurable disease (RECIST) or progression of bone disease must also fit the criterion for PSA progression.
    6) ECOG performance status: 0-1.
    7) Creatinine ≤1.5 x upper limit of normal (ULN) or a calculated creatinine clearance > 50 mL/min.
    8) Potassium ≥ 3.5mmol/l.
    9) Systolic blood pressure < 160 and diastolic < 100 mmHg documented on at least 3 different days.
    10) Ongoing gonadal androgen deprivation therapy with LHRH analogues or orchiectomy. Patients who have not had an orchiectomy, must be maintained on effective LHRH analogue therapy before and during the trial.
    11) Castrate testosterone level [< 50 ng/dL or < 2.00 nmol/L (nmol/L x 28.8 = ng/dL)].
    12) Normal baseline ACTH stimulation test. The criterion will be removed if no evidence of adrenocortical insufficiency is observed in the dose escalation phase.
    13) Life expectancy of ≥ 12 weeks.
    E.4Principal exclusion criteria
    1) Prior cytotoxic chemotherapy for prostate cancer (including estramustine, docetaxel and mitoxantrone). All other systemic chemotherapy must have been completed at least 2 years prior to enrolment.
    2) Prior therapeutic radionucleotide therapy for prostate cancer.
    3) External beam radiotherapy, brachytherapy or cryotherapy to the prostate bed within 4 weeks of start of study.
    4) Prior ketoconazole, aminoglutethimide or treatment with any investigational anticancer agent, including systemic corticosteroids for the treatment of prostate cancer, within 4 weeks of start of study.
    5) Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrolment. Progressive disease (as defined above) must be documented after discontinuation of the hormonal therapy.
    6) Treatment with any investigational anticancer agent within 4 weeks of start of study.
    7) Patients on stable doses of bisphosphonates that show subsequent tumour progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy within two weeks prior to starting therapy or throughout the study.
    8) No supplements or complementary medicines/botanicals are permitted while on protocol therapy, except for any combination of the following:
    • conventional multivitamin supplements
    • selenium
    • soy supplements
    9) Haemoglobin ≤ 9.0 g/dL, ANC ≤ 1.5 x 10 to the power of 9 /L,
    platelets ≤100 x 10 to the power of 9/L.
    10) Bilirubin > 1.5 x ULN, AST >2.5 x ULN, ALT > 2.5 x ULN.
    11) Patients with serious or uncontrolled co-existent non-malignant diseases. Active or uncontrolled infection.
    12) Patients with CNS disease and/or brain metastases.
    13) No “currently active” second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active” malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse.
    14) Clinical and/or biochemical evidence of hyperaldosteronism.
    15) Patients with well controlled hypertension with medication will be allowed after the dose escalation study is completed.
    16) NYHA Class III or IV Congestive Heart Failure.
    17) Myocardial infarction within the 6 months prior to start of study.
    18) No active or uncontrolled autoimmune disease that may require corticosteroid therapy during protocol treatment.
    19)Major surgery or significant traumatic injury within 4 weeks of start of study.
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed, objective PSA response (according to PSAWG criteria) resulting from abiraterone acetate therapy. All patients achieving a fall in PSA of >50% from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, will fulfill criteria for PSA response. Baseline measurements should be within three days of starting study therapy. Patients achieving a fall of their PSA to less than 0.2ng/ml will be reported as a subset of PSA responders.
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.7.1.3.1Other trial type description
    dose finding phase I/II
    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 Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Information not present in EudraCT
    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 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
    The final follow up (assessment) visit of the final patient will be at least 30 days following the last dose of abiratone acetate. If the final patient has an ongoing adverse event related to protocol treatment, the trial will end when the adverse event is resolved.

    Patients who are maintaining a response to therapy or who have stable disease at the end of the formal study period may be offered the opportunity to continue Abiraterone acetate treatment under a separate protocol.
    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 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 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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state65
    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 Decision2005-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-20
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