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    The EU Clinical Trials Register currently displays   36397   clinical trials with a EudraCT protocol, of which   5997   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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    EudraCT Number:2008-002120-29
    Sponsor's Protocol Code Number:0822-030
    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:2008-06-27
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2008-002120-29
    A.3Full title of the trial
    A Phase III Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Odanacatib) in Prolonging Bone Metastasis-Free Survival in Men with Castration-Resistant Prostate Cancer

    A.3.2Name or abbreviated title of the trial where available
    MK-0822 (Odanacatib) in Men with Hormone-Refractory Prostate Cancer
    A.4.1Sponsor's protocol code number0822-030
    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&Co.,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.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 nameMK-0822
    D.3.2Product code MK-0822
    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 codeMK0822
    D.3.9.3Other descriptive nameOdanacatib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Information not present in EudraCT
    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 placeboTablet
    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
    Prevention of bone metastases in men with prostate cancer

    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10005993
    E.1.2Term Bone metastases
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the effect of treatment with MK-0822 5 mg once daily on bone metastasis-free survival (defined as time to first bone metastasis or death from any cause) compared to placebo.
    • To assess the effect of treatment with MK-0822 5 mg once daily in a subset of 300 patients on lumbar spine, total hip, femoral neck, trochanter and total body bone mineral density (BMD) compared to placebo.
    • To assess the tolerability of treatment with MK-0822 5 mg once daily compared to placebo.
    E.2.2Secondary objectives of the trial
    • To assess the effect of treatment with MK-0822 5 mg once daily on the risk of developing bone metastases compared to placebo.
    • To assess the effect of treatment with MK-0822 5 mg once daily on the risk of death from any cause compared to placebo.
    • To assess the effect of treatment with MK-0822 5 mg daily on biochemical markers of bone turnover compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient is a man ≥18 years of age on the day of signing the informed consent.
    • Patient has hormone-refractory (androgen-independent) prostate cancer, defined as 3 rising, consecutive, historical PSA values following bilateral orchiectomy, or while receiving continuous (not intermittent) androgen-deprivation therapy. The second and third historical PSA tests (i.e., values obtained prior to the screening visit) must be separated from the previous test by at least 2 weeks, and the second and third values must each be ≥ 1.0 ng/mL.
    • Patient has a serum testosterone <50 ng/dL at screening.
    • Patient is at increased risk for prostate cancer progression defined as either an elevated PSA of ≥8 ng/mL obtained at the screening visit as measured by the central laboratory, or a PSA doubling time (PSADT) of ≤10 months (defined as ≤ 300 days).
    • Patient underwent bilateral orchiectomy 3 months or more (i.e., ≥90 days) prior to Visit 1, or is receiving androgen-deprivation therapy (ADT) and is on a stable GnRH agonist regimen for at least 3 months (i.e., ≥90 days) prior to Visit 1. ADT cannot be modified between Visit 1 and Visit 2 (the randomization visit). Androgen-deprivation therapy may include gonadotropin-releasing hormone agonists (GnRH) such as leuprolide, goserelin, or triptorelin. Patients receiving anti-androgen (e.g., flutamide, bicalutamide, nilutamide) monotherapy are not eligible, however, patients receiving an anti-androgen in combination with androgen deprivation (with a GnRH agonist or bilateral orchiectomy) are eligible, and in this case these therapies cannot be modified between Visit 1 and Visit 2. Patients who have failed anti-androgen monotherapy in the past, and are now failing androgen deprivation (with a GnRH agonist or bilateral orchiectomy) are also eligible.
    • Patient has not undergone radiotherapy, OR if patient has undergone radiotherapy he has recovered and is at least 4 weeks from the previous radiotherapy at the time of screening (Visit 1).
    E.4Principal exclusion criteria
    • Patient has bone metastases, or has a history of bone metastases: patient must have a negative bone scan obtained during the screening period, or within 1 month prior to the screening visit (Visit 1). All bone scans and associated imaging studies used for eligibility purposes must be adjudicated by the central radiologist before the patient may be randomized at Visit 2.
    • Patient has other distant metastases (e.g., visceral, including brain, or soft-tissue). Patients with regional lymph nodal metastases are eligible.
    • Patient has ANY of the following:
    a) is currently receiving a bisphosphonate (e.g., etidronate, clodronate, tiludronate, pamidronate, alendronate, ibandronate, risedronate, olpadronate, neridronate, zoledronate), or other drug therapy for osteoporosis;
    b) has been treated with an oral bisphosphonate within the 6 months prior to Visit 1;
    c) has been treated with an intravenous bisphosphonate within the 12 months prior to Visit 1.
    • Patient has received chemotherapy within the 2 years prior to Visit 1 (for example, doxorubicin, cyclophosphamide, estramustine, paclitaxel, docetaxel, etoposide, vinblastine, 5-fluorouracil, interferon, mitoxantrone). Patients may not start chemotherapy between Visit 1 and Visit 2. This exclusion criterion does not include androgen-deprivation therapy, which is permitted and expected in patients entering this study (e.g., gonadotropin-releasing hormone agonists such as leuprolide, goserelin, or triptorelin).
    • Patient is using any of the following potent inhibitors of CYP3A4 within 2 weeks prior to starting blinded study medication: (a) systemically administered azole antifungals such as ketoconazole, fluconazole, itraconazole, miconazole, posaconozole, ravuconazole, and voriconazole; (b) nefazodone; (c) the macrolide antibiotics clarithromycin, dirithromycin, erythromycin, and troleandomycin, however, azithromycin, is permitted. The use of any other macrolide antibiotic requires approval by the SPONSOR’s clinical representative. Patients who discontinue these medications at least two weeks prior to starting blinded study medication are eligible.
    E.5 End points
    E.5.1Primary end point(s)
    Time to First Bone Metastases
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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. 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 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.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    When the required number of primary endpoints has accrued. This is an event driven trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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 607
    F.4.2.2In the whole clinical trial 1550
    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)
    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 Decision2008-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-01-18
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