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    Summary
    EudraCT Number:2005-000535-18
    Sponsor's Protocol Code Number:ML17632
    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:2005-12-01
    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 number2005-000535-18
    A.3Full title of the trial
    Prospective, multicenter study to evaluate the renal safety of
    6 mg ibandronic acid infusions over 15 min or 60 min in patients with metastatic bone disease due to breast cancer.
    A.4.1Sponsor's protocol code numberML17632
    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 SponsorRoche Pharma (Schweiz) AG
    B.1.3.4CountrySwitzerland
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Bondronat 6mg/6ml
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, UK
    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.3.1Product nameBondronat 6mg/6ml
    D.3.2Product code Ro 200-5450
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNIbandronic acid
    D.3.9.2Current sponsor codeRo 200-5450
    D.3.9.3Other descriptive nameIbandronate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6/6
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The target population for this trial are female patients with primary breast cancer with metastatic bone disease.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the renal safety of 6 mg ibandronate i.v. infusions over 15 min by estimating the percentage of patients with an increase of serum creatinine of ≥ 44.2 µmol/l (= 0.5 mg/dl) from baseline.
    E.2.2Secondary objectives of the trial
    1. To evaluate the absolute change in serum creatinine from baseline to last value available assessment.
    2. To evaluate the relative % change in serum creatinine from baseline to last value available assessment.
    3. To evaluate the relative % change in calculated and measured creatinine clearance from baseline to last value available assessment.
    4. To evaluate the absolute change in calculated and measured creatinine clearance from baseline to last value available assessment.
    5. Serum creatinine levels per cumulative dose of ibandronate.
    6. To assess the absolute differences from baseline of tubular and glomerular markers: N-Acetyl-β-D-glucosaminidase, α1-microglobulin, microalbuminuria.
    7. To evaluate the efficacy on the reduction of bone pain, analgesic requirement and WHO performance status.
    8. Number of infusions and cumulative dose in comparison in both groups.
    9. To assess the safety and tolerability profile of ibandronate.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients must meet all of the following criteria in order to be eligible for this study.
    1. Written informed consent and willingness to participate to and comply with the study.
    2. Female gender.
    3. Age: ≥ 18 years.
    4. Histologically or cytologically confirmed breast cancer.
    5. At least one osteolytic, mixed or blastic bone metastasis confirmed by X-ray, CT scan or MRI. The assessment is not necessary if it was done within 6 months prior to screening.
    6. Metastases in other sites should be confirmed by X-ray, abdominal ultrasound or CT scan, if applicable. The assessment is not necessary if it was done within 6 months prior to screening.
    7. WHO performance status of 0, 1 or 2 at screening.
    8. If any bisphosphonate therapy is ongoing, the last dose has to be given ≥ 3 weeks prior to start of study medication.
    9. Antitumour therapies like chemotherapy, endocrine therapy or a therapy with Herceptin® are allowed, but should not be started at the same day as study medication. Patients not receiving any antineoplastic therapy are eligible providing they meet all other inclusion / exclusion criteria.
    10. Adequate renal function at screening defined by serum creatinine value within normal limits (44.2-120 µmol/l; assessed by central laboratory) and by calculated creatinine clearance ≥ 50 ml/min (Cockcroft-Gault; assessed by central laboratory).
    E.4Principal exclusion criteria
    Patients meeting any one of the following criteria are not eligible for this study.
    1. Life expectancy ≤ 6 months.
    2. Known hypersensitivity to ibandronate or other bisphosphonates.
    3. Patients with unstable pathological renal function defined as serum creatinine value (> 120 µmol/l; assessed by central laboratory) or calculated creatinine clearance < 50 ml/min (Cockcroft-Gault; assessed by central laboratory) within the last 3 months.
    4. High-dose chemotherapy (i.e. dose intensity > 3 times of standard therapy) within 6 months prior to start of study medication.
    5. Nephrotoxic chemotherapies like Cisplatin and Methotrexat at study start.
    6. Radiotherapy during the last 5 weeks.
    7. Abdominal metastases with renal involvement.
    8. Active infection of urinary tract at screening. Patient may have a screening once more after recovery.
    9. Proteinuria > 0.5 g/l (assessed by local laboratory).
    10. Uncontrolled hypercalcemia at study entry (serum calcium ≥ 3.0 mmol/l (12.0 mg/dl) albumin-corrected).
    11. Uncontrolled hypocalcemia at study entry (serum calcium ≤ 1.8 mmol/l (7.2 mg/dl) albumin-corrected).
    12. Actual treatment or treatment within the last 12 weeks prior to start of study medication with aminoglycoside antibiotics, antifungual antibiotics (i.e. Fungizone®) or any other known nephrotoxic medications. Diuretic agents must be stable within the last 4 weeks prior screening (patients with well controlled non-steroidal antirheumatic medication are eligible).
    13. History of a psychological illness or medical condition such as to interfere with the patient's ability to understand the requirements of the study (i.e. brain metastases after treatment with any impact on cognitive function) as judged by the investigator.
    14. Patient with organic (i.e. urinary incontinence) or mental disability to follow the instructions to collect 24 h urine sample as judged by the investigator.
    15. Women lactating, pregnant, of childbearing potential or less than one year after menopause (unless surgically sterile) not using a reliable contraceptive method: intrauterine device, mechanical contraception (condom, diaphragm), oral, injectable or implanted contraceptives or total abstinence. Women of childbearing potential must have a negative pregnancy test (serum) at screening.
    16. Patients who have received an investigational drug within the last 30 days.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with an increase of serum creatinine of ≥ 44.2 µmol/l (= 0.5 mg/dl) from baseline.
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 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 Information not present in EudraCT
    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
    End of the study is defined as last patient last observation (in CH after follow-up phase).
    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 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 months6
    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 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 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 2005-12-01. 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 130
    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)
    Upon completion of the 6 month core study, patients will be transferred to the routine therapy. The investigator takes responsibility for the decision about the subsequent treatment (e.g. treatment with Bondronat 6 mg 60 min i.v. according to the label).
    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 Decision2005-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-05-31
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