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    Summary
    EudraCT Number:2005-002132-94
    Sponsor's Protocol Code Number:CZOL446EDE28
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-11-23
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-002132-94
    A.3Full title of the trial
    „Effect of intravenous Zoledronic Acid on Bone Metabolism
    given over 4 month in patients with prostate cancer or breast cancer and bone metastasis. A prospective, single-arm multicenter study” (ZoTect)
    A.3.2Name or abbreviated title of the trial where available
    ZoTect
    A.4.1Sponsor's protocol code numberCZOL446EDE28
    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 SponsorNovartis Pharma GmbH
    B.1.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name Zometa
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.2Product code ZOL446
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZoledronic acid
    D.3.9.1CAS number 118072-93-8
    D.3.9.2Current sponsor codeZOL446
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with prostate or breast cancer with bone metastasis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036910
    E.1.2Term Prostate cancer NOS
    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 course of bone turn-over markers (PINP, bALP, ICTP and CTX)
    E.2.2Secondary objectives of the trial
    - Relationship between tumour burden/metastatic sites assessed by bone scan
    Soloway Score (63)) and level of bone markers at study entry
    - Pain assessment (VAS) and analgesics score
    - Relationship between Pain and course of bone turn-over markers
    - Rate of SREs
    - Relationship between SREs and bone turnover markers
    - Quality of life questionnaire (EORTC 30)
    - Course of PSA (Patients with prostate cancer only)
    - Course of urinary NTX ( in centers where storage at -20°C is possible)
    - Safety and Tolerability (adverse events (AEs), serious adverse events (SAEs))
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically proven carcinoma of the prostate with evidence of at least one cancer
    related bone lesion with or without hormonal treatment.
    - Histologically proven carcinoma of the breast with evidence of at least one cancer
    related bone lesion
    - Negative pregnancy test at screening in case of child-bearing potential.
    - Performance status ECOG 0-2
    - Laboratory requirements: a) hepatic function: total bilirubin ≤ 2,5 times the upper-
    normal limit of the institution, SGPT, SGOT ≤ 2,5 times the upper-normal limit of the
    institution.
    - Renal function: creatinine clearance more or equal 30 ml/min
    - Normal cardiac function
    - Life expectancy more or equal 6 months
    - Signed informed consent prior to trial entry
    - Patients of more or equal 18 years
    - Patients must be accessible for treatment
    - Standardized therapy for pre- und postmenopausal women is allowed
    - Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must
    have elapsed since the completion of surgery, chemotherapy and radiotherapy to
    breast or bone.
    E.4Principal exclusion criteria
    - Prior treatment with bisphosphonates within 6 months before study start, and
    during treatment with zoledronic acid
    - No presence of at least one cancer-related bone lesion that is detectable on
    conventional radiographs of bone or detectable on a bone scan and confirmed by
    MRT or CT at screening
    - Abnormal renal function as evidenced by
    A calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is
    calculated using the Cockcroft-Gault formula:

    CrCl = [[140-age (years)] x weight (kg)] / [72 x serum creatinine (mg/dL)]
    {x 0.85 for female patients}

    - Patients with clinically symptomatic brain metastases
    - History of diseases with influence on bone metabolism such as Paget´s disease
    and primary hyperparathyroidism and with need of treatment for osteoporosis
    (defined according to DVO, T-Score ≤2.5).
    - Severe physical or psychological concomitant diseases that expected to impair compliance with the provisions of the study protocol or impair the assessment of
    drug of patient safety (clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG)
    - Breast feeding or Pregnancy, confirmed by a positive serum hCG laboratory test (> 5 mIU/ml)
    - Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >25 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using one or more medically acceptable methods of contraception.
    - Known hypersensitivity to zoledronic acid or other bisphosphonates
    - Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or more or equal 12.0mg/dl (3.00 mmol/L)
    - Known history or present abuse of alcohol or drugs
    - Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
    - Previous Radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 1 month
    - Prior malignancy except basal cell or squamous cell skin cancer or any other cancer from which the patient has been disease-free for more or equal 5 yrs.
    - Use of other investigational drugs at the time of enrollment, or within 30 days before enrollment
    - Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
    - Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of the effect of Zoledronic Acid given every 4 weeks for 4 months on bone metabolism. Assessment will carried out by the course of bone turn-over markers.
    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 Information not present in EudraCT
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-11-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state405
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 405
    F.4.2.2In the whole clinical trial 405
    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 Decision2006-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-20
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