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    Summary
    EudraCT Number:2004-001101-10
    Sponsor's Protocol Code Number:CZOL446G2419
    National Competent Authority:Spain - AEMPS
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-001101-10
    A.3Full title of the trial
    A prospective, multicenter, randomized phase III study to evaluate the efficacy of Zometa (zoledronic acid) in preventing or delaying of bone metastasis in patients with stage III non-small cell lung cancer
    A.4.1Sponsor's protocol code numberCZOL446G2419
    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 Farmacéutica, S.A
    B.1.3.4CountrySpain
    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 Zometa 4mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameZometa 4mg/5ml concentrate for solution for infusion
    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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    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
    Patients with unresectable stage IIIA and IIIB Non small cell lung cancer (NSCLC) without bone metastases
    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
    The primary objective of the study is to evaluate the efficacy of Zometa in the prevention of bone metastases in patients with locally advanced, stage IIIA and IIIB NSCLC. The primary endpoint is time to occurrence of bone metastases. All patients in both arms will receive standard antineoplastic treatment at the discretion of their physicians. Patients in the treatment arm will receive Zometa every 3-4 weeks, depending on their chemotherapy regimen. For patients who are not receiving chemotherapy, the investigator decides whether Zometa will be given every 3 or every 4 weeks. The control arm will not receive Zometa treatment until development of bone metastases.
    E.2.2Secondary objectives of the trial
    Secondary objectives include evaluation of:
    • Rate of bone metastases (irrespective whether symptomatic or not ) at 6, 12, 18 and 24 months
    • Time to disease progression (TTP)
    • Risk of skeletal related events (SREs) at 12 and 24 months from study entry based on multiple event analysis by the Anderson-Gill method and rate of SRE at 12 and 24 months (proportion of patients having experienced at least one SRE) Skeletal-related events (SREs) are defined as:
    - radiation therapy to bone (including the use of radioisotopes)
    - surgery to bone
    - spinal cord compression events
    - pathologic bone fracture events
    • Time to first SRE
    • Survival at 12 and 24 months
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • Age ≥ 18 years
    • Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell
    carcinoma) NOTE: Mixed tumors with small cell carcinoma and aplastic carcinoma are not eligible
    • Newly diagnosed, Stage IIIA and Stage IIIB excluding patients with pleural effusion
    • Life expectancy of at least 6 months
    • ECOG performance status of 0 or 1 (Post-text suppl. 1)
    • Weight loss ≤ 5% in past 6 months
    • Women of childbearing potential must use a medically acceptable form of contraception
    during the study and must have a negative urine or serum pregnancy test within 7 days of
    randomization.
    • Adequate bone marrow reserve defined as white blood cell (WBC) ≥ 3500mm3,
    neutrophils ≥ 1500 mm3, platelets ≥ 100,000 mm3, Hb ≥ 9 g/dL
    • Able and willing to sign informed consent
    E.4Principal exclusion criteria
    • Patients with NSCLC with pleural effusion.
    • Patients who received any prior bisphosphonates in past 12 months
    • Presence of metastasis
    • Patients with current malignancy within past 5 years other than NSCLC (exceptions
    include treated melanoma, ductal carcinoma in situ of the cervix or other cancer cured by reception alone)
    • Patients who have received radiotherapy ≥ 3 weeks before randomization must have recovered from any adverse events occurring during radiotherapy
    • Previous thoracotomy must have been performed ≤ 3 weeks prior to randomization and patient must have recovered.
    • Any previous radiotherapy completed < 3 weeks before randomization
    • Patients with abnormal renal function (Creatinine > 3mg/dL)
    • Corrected serum calcium < 8.0 mg/dL
    • Known hypersensitivity to Zometa or other bisphosphonates
    • Patients with nonmalignant conditions which would confound the evaluation of the
    primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol,
    including:
    - Uncontrolled infections
    - Uncontrolled Type 2 Diabetes Mellitus
    - Diseases with influence on bone metabolism such as Paget’s disease or uncontrolled thyroid or parathyroid dysfunction
    - Cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which
    would prevent prolonged follow-up
    • Patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to evaluate the efficacy of Zometa in the prevention of bone metastases in patients with locally advanced, stage IIIA and IIIB NSCLC. The primary endpoint is time to occurrence of bone metastases. All patients in both arms will receive standard antineoplastic treatment at the discretion of their physicians. Patients in the treatment arm will receive Zometa every 3-4 weeks, depending on their chemotherapy regimen. For patients who are not receiving chemotherapy, the investigator decides whether Zometa will be given every 3 or every 4 weeks. The control arm will not receive Zometa treatment until development of 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 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) 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 Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 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 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
    All possible efforts must be made to determine the reason(s) why a patient fails to return for scheduled visits or is discontinued from the trial. If either study treatment or observations were discontinued for any patient, the reason will be recorded. Patients withdrawn during the trial will not be replaced. Patients who discontinue the study early should still complete an end of treatment assessment four weeks after the last dose.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    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 state67
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 446
    F.4.2.2In the whole clinical trial 446
    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 Decision2005-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
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