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    Summary
    EudraCT Number:2010-020395-28
    Sponsor's Protocol Code Number:ARD11588(MM-121-02-02-03)
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-11
    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 - PEI
    A.2EudraCT number2010-020395-28
    A.3Full title of the trial
    A Randomized, Double-Blind Phase 2 trial of Exemestane +/- MM-121 in Postmenopausal Women with Locally Advanced or Metastatic Estrogen Receptor Positive (ER+) and/or Progesterone Receptor Positive (PR+), Her2 negative Breast Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial of a new drug added to an existing approved treatment of patients with advanced breast cancer of specific type
    A.4.1Sponsor's protocol code numberARD11588(MM-121-02-02-03)
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMERRIMACK PHARMACEUTICALS
    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 supportMerrimack
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMERRIMACK PHARMACEUTICALS
    B.5.2Functional name of contact pointMerrimack MM121 Clinical Trial Mger
    B.5.3 Address:
    B.5.3.1Street AddressOne Kendall Square - Building 700, 2nd Floor, Suite B7201
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139 - USA
    B.5.4Telephone number1617441-1000
    B.5.5Fax number1617812-7776
    B.5.6E-mailclinical@merrimackpharma.com
    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.3.2Product code MM-121 (SAR256212)
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMM-121 (SAR256212)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 placeboConcentrate for solution 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
    Breast cancer
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether the combination of MM-121 + exemestane is more effective than exemestane alone based
    on Progression Free Survival (PFS).
    E.2.2Secondary objectives of the trial
    To compare the efficacy of the combination of MM-121 + exemestane to exemestane alone using :
    - Overall survival
    - Objective response rate and duration of response
    - Clinical benefit rate
    To determine the safety profile of the MM-121 + exemestane combination
    To determine the immunogenicity parameters of the MM-121 + exemestane combination
    To determine the pharmacokinetic parameters of the MM-121 + exemestane combination within a subset of
    patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be included in the study, patients must have/be:
    5.5.1. Progressed following treatment with prior anti-estrogen therapy in the locally advanced or metastatic setting, OR progressed during adjuvant treatment (or within 6 months following adjuvant treatment) with a non-steroidal aromatase inhibitor and/or tamoxifen
    5.5.2. Histologically or cytologically confirmed ER+ and/or PR+ and Her2 negative breast cancer
    5.5.3. Documented locally advanced or metastatic disease with at least one radiologically measurable lesion as defined by RECIST v1.1
    Exception: patients with bone-only metastatic disease are eligible if they have at least 2 lesions on a bone scan or other imaging modality (e.g. X-Ray, CT, PET-CT or MRI) and have documented disease progression on prior therapy based on the appearance of new lesions
    5.5.4. Able to understand and sign an informed consent (or have a legal representative who is able to do so)
    5.5.5. Postmenopausal female patients, as defined by the following:
    - 5 years since onset of menopause
    - Luteinizing hormone/follicle-stimulating hormone levels in the postmenopausal range in women whose
    menopause occurred less than 5 years before inclusion
    5.5.6. Unstained tumor slides from tumor tissue available for analysis
    5.5.7. ECOG Performance Score (PS) of ≤ 2
    5.5.8. Adequate bone marrow reserves as evidenced by:
    - ANC > 1,500/μl without the use of hematopoietic growth factors; and
    - Platelet count > 100,000/μl; and
    - Hemoglobin > 9 g/dL
    5.5.9. Adequate hepatic function as evidenced by:
    - Serum total bilirubin ≤ 1.5 x ULN
    - Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline Phosphatase ≤ 2.5 x ULN (≤5 x ULN is acceptable if liver metastases are present; ≤ 5 x ULN of Alkaline Phosphatase is acceptable if bone
    metastases are present)
    5.5.10. Adequate renal function as evidenced by a serum creatinine ≤ 1.5 x ULN
    5.5.11. Recovered from clinically significant effects of any prior surgery, radiotherapy or other antineoplastic
    therapy. Patients with a known peripheral neuropathy must present as Grade 1 or less, according to National
    Cancer Institute common terminology criteria [NCI CTCAE], version 4.0, to be eligible for inclusion.
    5.5.12. 18 years or above of age
    E.4Principal exclusion criteria
    Patients must meet all the inclusion criteria listed above and none of the following exclusion criteria:
    5.6.1. Received prior treatment with exemestane
    5.6.2. Received more than one prior chemotherapy regimen in the metastatic setting
    5.6.3. Extensive visceral disease (rapidly progressive, life -threatening metastases, including symptomatic lymphangitic metastases)
    5.6.4. Symptomatic CNS disease
    5.6.5. History of another malignancy in the last 5 years. Patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone and have been continuously disease free for at least 5 years.
    5.6.6. Active infection or an unexplained fever > 38.5°C during screening visits or on the first scheduled day of
    dosing, which in the investigator’s opinion might compromise the patient’s participation in the trial or affect the study outcome. At the discretion of the investigator, patients with tumor fever may be enrolled
    5.6.7. Known hypersensitivity to any of the components of MM-121 or who have had hypersensitivity reactions to fully human monoclonal antibodies
    5.6.8. Received other recent antitumor therapy including:
    - Investigational therapy administered within the 30 days prior to the first scheduled day of dosing in this study
    - Radiation or other standard hormonal therapy within 14 days prior to the first scheduled dose in this study,
    including, in addition if necessary, the timeframe for any actual or anticipated toxicities from such radiation or
    therapy
    5.6.9. NYHA Class III or IV congestive heart failure or LVEF < 55%. Patients with a significant history of cardiac disease (i.e. uncontrolled blood pressure, unstable angina, myocardial infarction within 1 year or ventricular arrhythmias requiring medication) are also excluded
    5.6.10. Recent (within 1 year) cerebral vascular accident (CVA)
    5.6.11. History of allergic reactions attributed to compounds of similar chemical or biologic composition as exemestane
    5.6.12. Planned bisphosphonate therapy which has not been initiated prior to randomization; bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first dose of randomized therapy
    5.6.13. Any other medical condition deemed by the Investigator to be likely to interfere with a patient’s ability to
    sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    E.5.2Secondary end point(s)
    * To compare the efficacy of the combination of MM-121 + exemestane to exemestane alone using
    * Overall survival
    * Objective response rate and duration of response
    * Clinical benefit rate
    * To determine the safety profile of the MM-121 + exemestane combination
    * To determine the immunogenicity parameters of the MM-121 + exemestane combination
    * To determine the pharmacokinetic parameters of the MM-121 + exemestane combination within a subset of patients
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    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 Yes
    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 parameters of the MM-121 + exemestane combination
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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
    The cut-off date for the study analysis will be when the last patient randomized reaches the 4 month evaluation visit.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    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)
    Patients are treated until disease progression or intolerable toxicity. Following removal from treatment on study patient will be treated in accordance with the local and/or institutional practice.
    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 Decision2011-11-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
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