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    Summary
    EudraCT Number:2008-002119-42
    Sponsor's Protocol Code Number:0822-029
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-07-17
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-002119-42
    A.3Full title of the trial
    A Phase III Study to Assess the Tolerability and Efficacy of MK-0822 (Odanacatib) in Reducing the Risk of Bone Metastases and Prolonging Disease-Free Survival in Women with Breast Cancer

    Spanish title:

    “Estudio de Fase III para evaluar la tolerabilidad y eficacia de MK-0822 (Odanacatib) en la reducción del riesgo de desarrollar metástasis óseas y en la prolongación de la supervivencia libre de progresión en mujeres con cáncer de mama”
    A.3.2Name or abbreviated title of the trial where available
    MK-0822 (Odanacatib) in Women with Breast Cancer
    A.4.1Sponsor's protocol code number0822-029
    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.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 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 codeMK-0822
    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.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 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 disease recurrence in patients with breast cancer.

    Spanish indication: Prevención de recurrencia de la enfermedad en pacientes con cáncer de mama
    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
    Objective: To assess the effect of treatment with MK-0822 5 mg once daily on the risk of developing a first bone metastasis (first disease recurrence) compared to placebo

    Objective: To assess the effect of treatment with MK-0822 5 mg once daily on disease-free survival compared to placebo

    Objective: To assess the effect of treatment with MK-0822 5 mg once daily in a subset of 250 patients on lumbar spine, total hip, femoral neck, trochanter and total body bone mineral density (BMD) compared to placebo

    Objective: To assess the tolerability of treatment with MK-0822 5 mg once daily compared to placebo
    E.2.2Secondary objectives of the trial
    (1) To assess the effect of treatment with MK-0822 5 mg on the risk of developing a first distant metastasis compared to placebo
    (2) To assess the effect of treatment with MK-0822 5 mg on the risk of death from any cause compared to placebo
    (3) To assess the effect of treatment with MK-0822 5 mg compared to placebo on time to a first bone metastasis and disease-free survival in subgroups of patients at high risk of developing distant recurrences based on the presence of molecular markers
    (4) To assess the ability of a combination of molecular markers (such as Celera 14-gene MetaScore or Genomic Health Oncotype DX) to identify a subgroup of breast cancer patients at high risk of developing bone metastases
    (5) To assess the effect of treatment with MK-0822 5 mg on biochemical markers of bone turnover compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient is a woman ≥18 years of age on the day of signing the informed consent
    • Patient has histologically and/or cytologically confirmed primary Stage II or Stage III breast cancer (must be lymph-node positive and/or with a tumor size >2 cm). regardless of HER-2 status. Stage I patients who are HER-2 positive based either on immunohistochemistry or fluorescent in situ hybridization (FISH technique), or who have a positive genetic signature for breast cancer recurrence using the Celera 14-gene MetaScore, or Genomic Health Oncotype DX, or Mammaprint, are also eligible.
    • If ER-negative breast cancer, patient has been diagnosed up to 2 years prior to study entry (Visit 1)

    OR

    • If ER-positive breast cancer, patient has been diagnosed up to 5 years prior to study entry (Visit 1)
    • Patient has undergone antineoplastic surgery and has recovered, and is at least 2 weeks from previous antineoplastic surgery at the time of screening (Visit 1).
    • Patient has not received adjuvant chemotherapy (e.g., cyclophosphamide, doxorubicin, carboplatin) or has completed adjuvant chemotherapy at least 6 weeks prior to the randomization visit (Visit 2). This inclusion criterion does not include hormone therapy, which is permitted (see inclusion criterion # 7).
    • Patient is not receiving hormonal therapy OR if patient is receiving hormonal therapy (e.g., leuprolide, tamoxifen, anastrozole) she is on a stable regimen for at least 3 months at the time of screening (Visit 1). If patient is HER2-positive and is receiving trastuzumab treatment, she must be on a stable regimen for at least 1 month at the time of Visit 1. Patients must also remain on this stable regimen between Visit 1 and Visit 2.
    • Patient has not undergone radiotherapy, OR if patient has undergone radiotherapy, she 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 can be randomized at Visit 2.
    • Patient has evidence of other distant metastases (e.g., visceral, soft-tissue, or brain).
    • Patient has had a prior local or regional recurrence of her breast cancer, or a contralateral tumor. DCIS (ductal carcinoma in-situ), and LCIS (lobular carcinoma in-situ) in either the ipsilateral or contralateral breast are permitted.
    • 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 is using any of the following potent inhibitors of CYP3A4 within 2 weeks prior to starting blinded study medication: (a) systemically or vaginally 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)
    Bone Metastases
    Disease Free Survival events
    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.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 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 concerned9
    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 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 years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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 Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state108
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 4000
    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)
    N/A
    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 Decision2008-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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