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    Summary
    EudraCT Number:2009-017668-18
    Sponsor's Protocol Code Number:C18002
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-02
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-017668-18
    A.3Full title of the trial
    A Phase 1/2, Open-Label Study in Men with Prostate Cancer to Assess the Safety, Pharmacokinetics, and Testosterone-Lowering Efficacy of TAK-448, Administered as a 1 Month Depot, Including a Randomized Portion With a Group Administered Leuprorelin
    A.4.1Sponsor's protocol code numberC18002
    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 SponsorMillennium Pharmaceuticals, 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 nameTAK-448-SR (1M)
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTAK-448
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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.IMP: 2
    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 Yes
    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.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEUPRORELIN
    D.3.9.1CAS number 53714560
    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 placeboSolvent for parenteral use
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prostate cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10007113
    E.1.2Term Cancer of prostate
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Protocol phase 1:
    - To assess the safety and pharmacokinetics of TAK 448 in patients receiving a single dose of a 1 month depot formulation of TAK-448

    Protocol phase 2:
    - To assess the safety in patients receiving repeated doses of a 1-month depot formulation of TAK-448
    - To assess the effect of repeated doses of a 1 month depot formulation of TAK 448 on serum testosterone concentrations
    - To assess the pharmacokinetics of TAK 448 in patients receiving multiple doses of a 1 month depot formulation of TAK-448
    E.2.2Secondary objectives of the trial
    Protocol phase 1:
    - In patients not on concomitant GnRH agonist therapy: to assess the effect of a 1 month depot formulation of TAK-448 on serum testosterone and luteinizing hormone (LH)

    Protocol phase 2:
    - To assess the effect of a 1-month depot formulation of TAK 448 on serum PSA concentration
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following criteria must be met by each patient to be eligible for the phase 1 or phase 2 portion of the study, unless otherwise specified:

    1. Male 40 to 72 years of age, inclusive.

    2. Histologically-confirmed adenocarcinoma of the prostate, having completed primary local treatment at least 6 months prior to screening.

    3. Screening serum PSA concentration > 2 ng/mL.

    4. For the phase 1 portion of the study only: Either
    a) Concurrent GnRH therapy with generally indolent or stable disease with PSA DT >6 months and absolute PSA <30 ng/mL and if metastatic disease, asymptomatic with only bone scan positive evidence of metastases. Patients with recurrent local disease will be asymptomatic without bladder, bowel, or obstructive symptoms.
    OR
    b) If not receiving GnRH therapy, a potential candidate for GnRH at some time in the future, i.e. in a period of ‘watchful waiting’ with generally indolent or stable disease with PSA DT >6 months and absolute PSA <30 ng/mL, and if metastatic disease, asymptomatic with only bone scan positive evidence of metastases. Patients with
    recurrent local disease will be asymptomatic without bladder, bowel, or obstructive symptoms.

    5. For the phase 2 portion of the study only: Evidence of progressive prostate cancer, which in the opinion of the referring physician and/or study investigator warrants the initiation of GnRH analog therapy. Such patients may have either elevated or rising PSA at least 6 months following primary local therapy(ies) or have evidence of metastatic disease not previously treated with first line hormone (GnRH analog) therapy. Patients are not eligible for inclusion if they are to receive first line hormone therapy for adjuvant/neoadjuvant therapy as part of local treatment of disease (surgery or radiation) or for primary local tumor control.

    6. Provision of informed consent and, for the phase 1 portion of the study only, willing to participate in a phase 1 trial with no expectation of therapeutic benefit.

    7. Generally fit medical condition, with no acute or chronic medical conditions, other than prostate cancer, affecting 2 year life expectancy.
    a) ECOG performance status 0 or 1
    b) New York Heart Association classification 0 to II
    c) Serum creatinine < 1.5 ULN
    d) If hypertensive, on 2 or fewer agents and with blood pressure adequately or well controlled (systolic <150
    mmHg, diastolic <95 mmHg)
    e) Hemoglobin >11.0 g/dL
    f) Total bilirubin must be <1.5 x ULN
    g) Generally normal laboratory evaluation, liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase [GGT]) within 2 times the ULN as reported by the central reference laboratory.

    8. Ability to understand and comply with protocol requirements.

    9. Agreement to, even if surgically sterilized but not surgically castrated (i.e. status postvasectomy):
    - Practice effective barrier contraception:
    Phase 1 portion of the study: during the entire study treatment period and through 3 months after the dose of study drug
    Phase 2 portion of the study: during the entire study treatment period through 2 months after the last dose of study drug
    OR
    - Abstain from heterosexual intercourse

    10. Suitable venous access for the study-required blood sampling, i.e. including PK and pharmacodynamic sampling.
    E.4Principal exclusion criteria
    1. Advanced or symptomatic metastatic prostate cancer requiring immediate GnRH or
    additional hormone (CAB) therapy or requiring chemotherapy

    2. History of surgical castration

    3. Any history of nonskin cancer, other than prostate cancer, requiring active treatment within the 2 years prior to screening

    4. Any history of cardiac surgery, within the previous 6 months or any planned elective surgeries, other than skin surgery, during the ensuing 6 months

    5. Any compromise of bone marrow function that would reduce tolerance to repeated
    blood draws

    6. Any history of osteoporosis, unless actively controlled with treatment, or history of
    vertebral or femoral fracture within the past year

    7. Any history of seizures or currently on anticonvulsant medications

    8. Any history of major psychiatric illness, eg, diagnosed psychosis or psychiatric
    illness requiring hospitalization within the previous year

    9. Any history of drug or significant alcohol abuse

    10. Any participation in clinical trials or receipt of any experimental therapy within
    2 months of screening

    11. Serious infection within 14 days before the first dose of study drug

    12. Known human immunodeficiency virus positive

    13. Known hepatitis B surface antigen-positive (HBsAg), or known or suspected active hepatitis C infection

    14. Any of the following cardiovascular conditions or values at the time of screening
    unless otherwise specified:
    • History of myocardial infarction, unstable symptomatic ischemic heart
    disease, ongoing arrhythmias of grade > 2 ( CTCAE version 4.02(13)),
    thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or
    symptomatic cerebrovascular events), or any other cardiac condition (eg,
    pericardial effusion or restrictive cardiomyopathy) within 6 months prior to
    first dose of study drug. Atrial fibrillation on anticoagulant therapy is not
    allowed.
    • QTc > 500 milliseconds.
    • Abnormalities on 12-lead ECG including, but not limited to, changes in
    rhythm and intervals that in the opinion of the investigator are considered to
    be clinically significant.
    In addition, for the phase 2 portion of the study, patients must not have any of the
    following exclusion criteria:

    15. Participation in the phase 1 portion of the study

    16. Prior or current use of a GnRH analog or androgen receptor antagonist as first-line hormone therapy (ie, other than as neoadjuvant/adjuvant use)

    17. History of use of GnRH analog or antagonist (as adjuvant or neoadjuvant therapy) within the 6 months prior to screening

    18. History of known or documented primary failure of GnRH analog therapy

    19. History of rising PSA or disease progression while on a GnRH analog or CAB
    therapy (ie, rising PSA while on neoadjuvant/adjuvant therapy)

    20. Screening serum testosterone concentration < 150 ng/dL (5.25 nmol/L)
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1 of the protocol:

    - Safety (vital signs, 12-lead ECG, clinical laboratory tests, injection site-related skin reactions, adverse events)
    - Pharmacokinetics of TAK-448 (Cmax on Day 1, AUC(0-24h), AUC(0-29 days), AUC(0-last), time of last quantifiable concentration)

    Phase 2 of the protocol:

    - Safety (vital signs, 12-lead ECG, clinical laboratory tests, injection site-related skin reactions, adverse events)
    - Pharmacodynamics (serum testosterone level and proportion of patients below castrate-level serum testosterone on Day 1 of each month of therapy)
    - Pharmacokinetics of TAK-448 (AUC(0-end of month 1), trough concentration on Day 1 of each month of therapy)
    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 No
    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) Yes
    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
    Safety/PK study of depot formulation
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Randomisation will occur in the phase II portion of the study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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.8.4.1Number of sites anticipated in Member State concerned6
    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 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
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 99
    F.4.2.2In the whole clinical trial 99
    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 Decision2010-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-09
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