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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2008-001727-65
    Sponsor's Protocol Code Number:IMCL CP12-0606/TRIO-012
    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:2008-11-12
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2008-001727-65
    A.3Full title of the trial
    Estudio en fase III, multicéntrico, multinacional, aleatorizado, doble ciego de IMC 1121B más docetaxel frente a placebo más docetaxel en pacientes con cáncer de mama HER2 negativo, irresecable, localmente recurrente o metastásico no tratadas previamente.

    A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients with HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer
    A.4.1Sponsor's protocol code numberIMCL CP12-0606/TRIO-012
    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 SponsorImClone Systems Incorporated
    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 nameIMC-1121B
    D.3.2Product code IMC-1121B
    D.3.4Pharmaceutical form 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.3.9.1CAS number 947 687-13-0
    D.3.9.2Current sponsor codeIMC-1121B
    D.3.9.3Other descriptive namerecombinant human IgG1 monoclonal antibody (MAb) targeted to VEGFR-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 No
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adenocarcinoma de mama HER2 negativo, metastático o localmente recurrente e irresecable.

    HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast 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 10027475
    E.1.2Term Metastatic breast cancer
    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 this study is to compare the PFS of the drug combination
    IMC -1121B plus docetaxel to placebo plus docetaxel in previously untreated patients with HER2-negative, unresectable, locally-recurrent or metastatic breast cancer.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    · to compare the overall survival of the drug combination IMC -1121B plus docetaxel to placebo plus docetaxel in previously untreated patients with HER2-negative, unresectable, locally-recurrent or metastatic breast cancer
    · to compare the TTP, ORR, and duration of response between the two treatment arms
    · to compare the safety of the two treatment arms
    · to compare the quality of life of the two treatment arms
    · to assess the immunogenicity of IMC-1121B
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet the following criteria to be randomized in this study:
    1. The patient is able to provide signed informed consent.
    2. The patient is female and ≥ 18 years of age or older if required by local laws or regulations.
    3. The patient has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.
    4. The patient has measurable and/or non-measurable disease.
    5. The patients’ primary and/or metastatic tumor is HER2-negative by fluorescence in situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC).
    6. The patient has not received prior chemotherapy for metastatic or locally recurrent and inoperable breast cancer.
    7. The patient completed (neo) adjuvant taxane therapy at least 6 months prior to randomization.
    8. The patient completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization.
    9. The patient completed all prior radiotherapy with curative intent ≥ 3 weeks prior to randomization.
    10. The patient may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting ≥ 2 weeks prior to randomization.
    11. The patient’s left ventricular ejection fraction is within normal institutional ranges.
    12. The patient has resolution to grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade ≤ 2.
    13. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
    14. The patient is amenable to compliance with protocol schedules and testing.
    15. The patient has adequate hematological functions (absolute neutrophil count [ANC] ≥ 1500 cells/mL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000 cells/mL and
    ≤ 850,000 cells/mL).
    16. The patient has adequate hepatic function (bilirubin within normal limits [WNL],
    aspartate transaminase [AST] and alanine transaminase [ALT] ≤ 2.5 times the upper limit of normal [ULN], or ≤ 5.0 times the ULN if the transaminase elevation is due to liver metastases, and alkaline phosphatase ≤ 5.0 times the ULN).
    17. The patient has serum creatinine ≤ 1.5 x ULN. If serum creatinine > 1.5 x ULN the
    calculated creatinine clearance should be > 40 mL/min).
    18. The patient’s urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA); if urine
    protein ≥ 2+, a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study.
    19. The patient must have adequate coagulation function as defined by international
    normalized ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN if not receiving anticoagulation therapy. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding (defined as within 14 days of randomization) or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices).
    20. Women of childbearing potential must implement adequate contraception in the opinion of the investigator.
    E.4Principal exclusion criteria
    A patient who has any of the following criteria will be excluded from the study:
    1. The patient has a concurrent active malignancy other than breast adenocarcinoma,
    adequately treated non-melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that she has been disease free for > 3 years.
    2. The patient has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80.
    3. The patient has a known sensitivity to agents of similar biologic composition as IMC-1121B or other agents that specifically target VEGF.
    4. The patient has a history of chronic diarrheal disease within 6 months prior to randomization.
    5. The patient has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (eg, pelvic or abdominal radiation) within 30 days prior to randomization.
    6. The patient has participated in clinical trials of experimental agents within 4 weeks prior to randomization.
    7. The patient has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders.
    8. The patient has active, high risk bleeding (eg, via gastric ulcers or gastric varices) within 14 days prior to randomization.
    9. The patient has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.
    10. The patient has uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator.
    11. The patient has brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
    12. The patient has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
    13. The patient has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
    14. The patient is pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this trial, Progression Free Survival, is defined as the time from randomization until the first evidence of progression as defined by RECIST, modified based on current practice of the medical community, or death from any cause. Patients who did not progress will be censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post initiation radiographic assessment is available. Patients who do not receive study treatment and who have neither progressed nor died will be censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post initiation radiographic assessment is available. If there are no postbaseline tumor measurements for randomized and treated patients, the patient will be censored at the date of randomization. If death or PD occurs after two or more missing radiographic visits, censoring will occur at the date of the last radiographic visit.
    The final analysis of PFS will include sensitivity analyses under the following conditions:
    · using the investigator PFS results
    - as provided, including symptomatic/clinical deterioration as a progression outcome
    - censoring symptomatic/clinical deterioration as a progression outcome to parallel the IRC results using only objective response
    · using the IRC provided PFS from the Per Protocol population
    · using the IRC provided PFS results from the ITT population, considering different
    censoring rules to control for missing data and/or lost to follow-up, as described in the Statistical Analysis Plan (SAP).
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity and circulating tumor cells testing
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA64
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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 state114
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 474
    F.4.2.2In the whole clinical trial 1113
    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 Decision2009-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-19
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