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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2008-000422-39
    Sponsor's Protocol Code Number:8669-002-01
    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:2008-11-24
    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 number2008-000422-39
    A.3Full title of the trial
    A Phase IIA Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide with or without Deforolimus in Men with Asymptomatic, Metastatic Castrate-Resistant Prostate Cancer
    A.4.1Sponsor's protocol code number8669-002-01
    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 SponsorMerck Sharp & Dohme Corp.
    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 nameridaforolimus
    D.3.2Product code AP23573 or MK-8669
    D.3.4Pharmaceutical form Gastro-resistant 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.3.8INN - Proposed INNridaforolimus
    D.3.9.1CAS number 572924-54-0
    D.3.9.2Current sponsor codeAP23573
    D.3.9.3Other descriptive nameMK-8669
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboGastro-resistant tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic prostate cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 efficacy of the combination of ridaforolimus and bicalutamide compared to placebo and bicalutamide by PSA decline within 12 weeks, a surrogate measurement of overall survival efficacy in prostate cancer therapy trials.

    To determine the safety and tolerability of ridaforolimus when combined with bicalutamide.
    E.2.2Secondary objectives of the trial
    To determine the efficacy of the combination of ridaforolimus and bicalutamide compared to placebo and bicalutamide by PSA response rate.

    To determine the efficacy of the combination of ridaforolimus and bicalutamide compared to placebo and bicalutamide by progression free survival (PFS) analysis.

    To determine the efficacy of the combination of ridaforolimus and bicalutamide compared to placebo and bicalutamide by time to PSA progression.

    To evaluate the pharmacokinetic profile of ridaforolimus when administered in combination with bicalutamide.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient has histologically confirmed adenocarcinomas of the prostate.
    2. Archival pathological material is available for submission to central laboratory.
    3. Patient has evidence of metastatic disease at protocol entry or at the time of prior hormonal manipulation, determined radiographically by the presence of at least 2 bone scan lesions consistent with metastases or abdominal/pelvic lymph nodes > 2 cm on longest axial measurement. Solitary or ambiguous bone lesions should be confirmed with plain radiographs or magnetic resonance imaging (MRI).
    4. Patient has evidence of disease progression despite castrate levels of testosterone (< 50 ng/dl) following orchiectomy or during therapy with a luteinizing hormone releasing hormone (LHRH) agonist or antagonist (with or without an anti-androgen). Evidence of disease progression must include one of the following:
    a) Levels of PSA are defined as increasing when at least three measurements, obtained at least one week apart, show increases. (The minimum starting PSA level for trial entry is 7 ng/mL except during safety lead-in.)
    b) Progressive lymph node disease is defined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The longest diameter of any node must measure at least 2 cm on spiral computed tomography (CT) to qualify as a target lesion.
    c) Worsening bone scan is defined as an increase of 2 or more lesions from a previous bone scan. Solitary or ambiguous bone lesions should be confirmed with plain radiographs or MRI.
    5. Patient has a PSA > 7 ng/ml (during safety lead-in only patients meeting other eligibility criteria may be enrolled with any PSA value).
    6. aminimum of four weeks has elapsed between prior surgery or radiotherapy (limited to no more than 25% of the bone marrow) and enrollment.
    7. Patient maintains therapy with a LHRH agonist or antagonist for the duration of the study, or has undergone bilateral orchiectomy.
    8. Patient has performance status ≤1 on ECOG performance scale.
    9. Patient is ≥18 years and gives written consent.
    10. Paitnets who are not surgically steril are required to use a reliable method of contraception from time of screening until 30 days after the last dose of study drug.
    11. Patient has adequate organ function.
    E.4Principal exclusion criteria
    1. Patient has received bicalutamide, flutamide, cyproterone or nilutamide within the past 12 months except for use of less than 30 days duration during the initiation of LHRH analog therapy (during safety lead-in only patients meeting other eligibility criteria may be enrolled as long as they have not received any anti-androgen withihn the past 4 weeks).
    2. Patient has received prior chemotherapy for metastatic prostate cancer.
    3. Patient has previously received rapamycin or rapamycin analogs, including ridaforolimus, temsirolimus, or everolimus or is receiving corticosteroids administered at doses greater than those used for normal replacement therapy.
    4. Patient is receiving an opioid or narcotic analgesic prescribed for pain due to prostate cancer.
    5. In the opinion of the investigator, the patient has pain related to metastatic prostate cancer that warrants the initiation of chemotherapy.
    6. Patient has a history of prior malignancy including primary central nervous system tumour, with the following exceptions: basal cell carcinoma of the skin; or any patient who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk of recurrence by his treating physician.
    7.Patient has any visceral matastatic disease including malignant pleural effusions or ascites, current or previuosly treated epidural disease, active or treated CNS metastases and or carcinomatous meningitis. Exception: patients with treated epidural lesions and no other epidural progression are eligible for study entry.
    8. Patient has known hypersensitivity to macrolide antibotics 9i.e. clarithomycin, erythromycin, or azythromycin); or bicalutamide.
    9. Patient has NYHA Class III or IV congestive heart failure or any other significant history of cardiac disease including: myocardial infarction within the last 6 months; ventricular arrhythmia or acute congestive heart failure within the last 3 months; uncontrolled angina or uncontrolled hypertension.
    10. Patient has newly diagnosed (within 3 months before enrollment) or poorly controlled Type 1 or 2 diabetes.
    11. Patient has an active infection requiring prescribed intervention.
    12. Patient is known to be human immunodeficiency virus (HIV) positive.
    13. Patient has a known history of Hepatitis B or C.
    14. Patient has known psychiatric or substnace abuse disorders that would interfere with cooperation with the requirements of the trial.
    15. Patient is at the time of signing informed consent a regular user ( including "recreational use") of any illicit drugs or has a recent history (within the last year) or drug or alcohol use.
    16. Patient has not adequately recovered from any prior surgical procedure or as undergone any major surgical procedure within 2 weeks prior to the first dose of study drug (patients having undergone recent placement of a central venous access port will be considered eligible if they have fully recovered).
    17. Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study or interfere with the patient's participation for the full duration of the study, or it is not in the best interest of the patient to participate.
    18. Patient has a requirement for concurrent treatment with medications that are inducers or inhibitors of cytochrome P450 3A (CYP3A). Patients should be off these medications for at least 2 weeks prior to the first dose of ridaforolimus. Concomitant medications that are metabolised by CYP3A are allowed (e.g. simvastatin or atorvastatin).
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    30% PSA decline with 12 weeks: defined as a >=30% decline from baseline with the first 12 weeks of study treatment. The decline is determined by the lowest post-baseline PSA value with the first 12 weeks.

    Safety:
    Tolerability will be assessed by clinical review of all relevant adverse experiences and monitoring variables related to laboratory measurements, physical examinations, and vital signs.
    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 No
    E.6.7Pharmacodynamic No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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 Yes
    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 Last Patient
    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 months10
    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 months10
    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) 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 180
    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 Decision2008-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-05-12
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