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    Summary
    EudraCT Number:2006-005964-24
    Sponsor's Protocol Code Number:CRO-06-78 / DSC/06/LEU15/01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-01-07
    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 number2006-005964-24
    A.3Full title of the trial
    Pharmacokinetics, pharmacodynamics and safety of a new Leuprolide acetate 22.5 mg depot formulation, when given as palliative treatment to prostate cancer patients
    A.4.1Sponsor's protocol code numberCRO-06-78 / DSC/06/LEU15/01
    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 SponsorItalfarmaco S.p.A.
    B.1.3.4CountryItaly
    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 nameLeuprolide acetate
    D.3.2Product code LF-LH
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEUPRORELIN ACETATE
    D.3.9.1CAS number 74381536
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.5
    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 Yes
    D.3.11.13.1Other medicinal product typesynthetic LHRH analogue
    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
    Prostate cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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
    Part A: preliminary investigation of the safety, pharmacodynamics and pharmacokinetics of a new leuprolide acetate depot 3-month formulation after i.m. or s.c. administration to patients with prostate cancer.

    Part B: investigation of the safety, pharmacodynamics and pharmacokinetics of a new leuprolide 3-month formulation in patients with prostate cancer after administration of a single dose of 22.5 mg leuprolide acetate by i.m. or s.c. injection (according to the results of study part A, see § 3.2).
    E.2.2Secondary objectives of the trial
    -Main testosterone PD parameters (see § 9.2.1).
    -Serum FSH / LH concentrations, PSA concentrations.
    -WHO/ECOG performance status (scores) (see Appendix B), bone pain, urinary pain/urinary symptoms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males >= 18 years of age, with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy;
    2. life expectancy of at least 1 year;
    3. World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1, or 2;
    4. adequate renal function at screening as defined by serum creatinine <= 1.5 times the upper limit of normal (ULN) for the clinical laboratory;
    5. adequate and stable hepatic function as defined by bilirubin <= 1.5 times the ULN and transaminases (i.e. AST, ALT) <= 2.5 times the ULN for the clinical laboratory at screening;
    6. ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study;
    7. signed written informed consent prior to inclusion in the study.
    E.4Principal exclusion criteria
    Evidence of brain metastases, taking into account medical history, clinical observations and symptoms; evidence of spinal cord compression, taking into account medical history, clinical observations and symptoms; evidence of severe urinary tract obstruction with threatening urinary retention, taking into account medical history, clinical observations and symptoms; presence of any tumour in the immediate vicinity which could cause cord compression; severe pain from extensive osseous deposits, taking into account medical history, clinical observations and symptoms; testosterone levels less than 1.5 ng/mL at screening, locally determined at the laboratory of each clinical site; previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g. antibody therapies, tumour-vaccines), biological response modifiers (e.g. cytokines) within 3 months of baseline; previous hormonal therapy for treatment of prostate cancer, such as LHRH analogues (no wash-out allowed); previous treatment with androgen receptor blockers, such as Casodex®, Fugerel®, Megace®, Androcur® (no wash-out allowed); previous orchiectomy, adrenalectomy or hypophysectomy; previous prostatic surgery within 2 weeks of baseline; previous local therapy to the primary tumour with a curative attempt other than surgery within 2 weeks of baseline; any investigational drug within 5 half-lives of its pharmacological action or 3 months, whichever is longer, before baseline; administration of 5--reductase inhibitors within 3 months before baseline; OTC or alternative medical therapies which have an estrogenic or anti-androgenic effect within the 3 months before baseline; haematological parameters outside 20% of the upper or lower limits of normal for the clinical laboratory at screening;
    co-existent malignancy other than prostate cancer; uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure or significant symptomatic cardiovascular disease(s) within 6 months before baseline; resting uncontrolled hypertension: ( 160/100 mmHg) or symptomatic hypotension within 3 months before baseline; venous thrombosis within 6 months of baseline;
    uncontrolled diabetes (patients with uncontrolled diabetes need to compensate the metabolic disorder before treatment with LH-RH analogues); history of drug and/or alcohol abuse within 6 months of baseline; serious concomitant illness(es) or disease(s) that may interfere with, or put patients at additional risk for, their ability to receive the treatment outlined in the protocol; patients on anticoagulant therapy; blood donations/losses within 2 months of baseline, apart from previous prostatic surgery patients; known hypersensitivity to GnRH, GnRH agonist, including any LHRH analogues, or any excipients of the study formulation
    history of the following prior to the study: immunization (within 4 weeks of baseline); flu shots (within 2 weeks of baseline); anaphylaxis; skin disease which would interfere with injection site evaluation; dermatographism will be documented at screening and followed up while on treatment
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    - At least seven out of eight patients (i.e. 87.5%) achieving castrate levels of serum testosterone (< 0.5 ng/ml) on study day 28, and maintaining castrate levels of serum testosterone throughout the study up to study day 84 after single i.m. or s.c. injection of leuprolide acetate 22.5 mg.
    - Leuprolide PK parameters after single i.m. or s.c. injection of leuprolide acetate 22.5 mg.

    Part B:
    - Number of patients achieving castrate levels of serum testosterone (< 0.5 ng/ml) on study day 28 and maintaining castrate levels of serum testosterone throughout the study up to day 84 following i.m. or s.c. administration of leuprolide acetate 22.5 mg.
    - Leuprolide PK parameters after single i.m. or s.c. injection of leuprolide acetate 22.5 mg.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    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 Yes
    E.8.2.3.1Comparator description
    administration route
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    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 years0
    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 years0
    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 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) No
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Normal treatment for prostate cancer according to the doctor's opinion
    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 Decision2007-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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