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    Summary
    EudraCT Number:2011-003576-36
    Sponsor's Protocol Code Number:ARD11586(MM-121-04-02-08)
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-05-24
    Trial 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 number2011-003576-36
    A.3Full title of the trial
    A Phase II Randomized Open Label Study of MM-121 in
    combination with Paclitaxel versus Paclitaxel alone in
    patient with Platinum Resistant/Refractory Advanced
    Ovarian Cancers.
    Eine randomisierte offene Phase-II-Studie mit MM-121 in Kombination mit Paclitaxel versus Paclitaxel allein bei Patientinnen mit platinresistentem/-refraktärem fortgeschrittenem Ovarialkarzinom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial studying Paclitaxel with or without MM-121 for patients with advanced ovarian cancer.
    A.4.1Sponsor's protocol code numberARD11586(MM-121-04-02-08)
    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, INC.
    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 PHARMACEUTICALS, INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMERRIMACK PHARMACEUTICALS, INC.
    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
    B.5.3.4CountryUnited States
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 namePaclitaxel
    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.3.8INN - Proposed INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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) 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 No
    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
    Patient with Platinum Resistant/Refractory Advanced Ovarian Cancers.
    E.1.1.1Medical condition in easily understood language
    Advanced ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian 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 plus paclitaxel is more effective than paclitaxel alone based on Progression Free Survival (PFS) in advanced ovarian cancers resistant or refractory to platinum agents.
    E.2.2Secondary objectives of the trial
    - To compare the efficacy of the combination of MM-121 plus paclitaxel to paclitaxel alone using:
    o Overall survival
    o Objective response rate and duration of response
    o Clinical benefit rate, defined as complete response (CR), partial response (PR), and disease stabilization (SD) lasting at least 6 months
    - To assess Health-Related Quality of Life (HRQL) using the Functional Assessment of Cancer
    Therapy-Ovarian (FACT-O), and the FACT-Taxane questionnaire.
    - To correlate a pre-specified five biomarker panel reflective of ErbB3 signaling activity with the
    clinical outcome of the patients (correlation between PFS and other clinical efficacy criteria with
    biomarker signature)
    - To further characterize the safety profile of the MM-121 plus paclitaxel combination
    - To gather exploratory data on additional potentially predictive set of biomarkers to be measured in blood and tumor tissue
    - To determine the immunogenicity of the MM-121 plus paclitaxel combination
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order for inclusion, patients must have/be:
    - Cytological or histological confirmation of locally advanced/metastatic or recurrent epithelial ovarian cancer, or fallopian tube cancer, or primary peritoneal cancer.
    - Evidence of recurrent or persistent disease following primary chemotherapy
    - Received at least one prior platinum based chemotherapy regimen for management of primary or recurrent disease. The platinum agent could have been carboplatin, cisplatin, or another organoplatinum compound. High dose therapy, consolidation treatment, or extended therapy delivered after surgical or non-surgical assessment is also permitted.
    - ”Platinum-resistant or refractory’’ according to standard GOG criteria defined as the following:
    o Recurrence of disease following completion of platinum therapy of < 6 months
    o Incomplete response or progression during most recent platinum based therapy
    - Clinically eligible for weekly paclitaxel – per the investigator‟s judgment
    - Willing to submit unstained tumor tissue if available for analysis from primary surgery or before baseline Willing to undergo a pre-treatment biopsy
    o Availability of a cancerous lesion that is amenable to biopsy
    - ≥ 18 years of age
    -Candidates for chemotherapy
    -Able to understand and sign an informed consent (or have a legal representative who is able to do so)
    - Measurable disease according to RECIST v1.1
    - ECOG performance Status (PS) of:
    • 0,1 – for patients with 3 or more prior therapies
    • 0,1,2 – for patients with 2 or less prior therapies 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
    - Adequate bone marrow reserves as evidenced by:
    o ANC > 1,500/μl without the use of hematopoietic growth factors; and
    o Platelet count > 100,000/μl; and
    o Hemoglobin > 9 g/dL
    o Serum total bilirubin ≤ 1.5 x ULN
    o Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline Phosphatase ≤ 2.5 x ULN (≤ 2.5 x ULN is acceptable if liver metastases are present and ≤ 5 x ULN of Alkaline Phosphatase is acceptable if bone metastases are present)
    - Adequate renal function as evidenced by a serum creatinine ≤ 1.5 x ULN
    - Have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception if hysterectomy and/or oophorectomy were not part of the prior treatment. It is expected that the overwhelming majority of ovarian cancer patients would have had hysterectomy and oophorectomy as part of the original surgery
    E.4Principal exclusion criteria
    Patients must meet all the inclusion criteria listed above and none of the following exclusion criteria:
    - Prior radiation therapy to >25% of bone marrow-bearing areas
    - Evidence of any other active malignancy
    - Active infection or an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled), which in the investigator‟s opinion might compromise the patient‟s participation in the trial or affect the study outcome
    - Symptomatic CNS disease
    - Known hypersensitivity to any of the components of MM-121 or who have had hypersensitivity reactions to fully human monoclonal antibodies
    - Received treatment, within 30 days prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state
    - Received other recent antitumor therapy including:
    o Investigational therapy administered within the 30 days prior to the first scheduled day of dosing in this study
    o Radiation or other standard systemic therapy within 14 days prior to the first scheduled dose in this study, including, in addition (if necessary), the timeframe for resolution of any actual or anticipated toxicities from such radiation
    - NYHA Class III or IV congestive heart failure or LVEF less than normal, per institutional guidelines or < 55%, if not otherwise specified by institutional guidelines. 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
    - History of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL, unless the patient has been desensitized in accordance with the institutional protocol
    - 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
    Die Patientinnen müssen alle oben aufgeführten Einschlusskriterien und dürfen keines der folgenden Ausschlusskriterien erfüllen:
    • Vorausgegangene Strahlentherapie von > 25 % der Knochenmarkfläche
    • Nachweis eines anderen Malignoms
    • Floride Infektion oder unerklärtes Fiber von > 38,5 °C bei den Screening-Terminen oder am Tag der ersten geplanten Arzneimittelgabe (nach Ermessen des Prüfarztes können Patientinnen mit Tumorfieber aufgenommen werden), die nach Meinung des Prüfarztes die Teilnahme an der Studie oder das Studienergebnis beeinträchtigen könnten
    • Symptomatische ZNS-Erkrankung
    • Bekannte Überempfindlichkeit gegen einen der Bestandteile von MM-121 oder stattgehabte Überempfindlichkeitsreaktionen gegen rein humane monoklonale Antikörper
    • Behandlung mit Prüfpräparaten innerhalb von 30 Tagen vor der geplanten ersten Arzneimittelgabe, die nicht für eine Indikation oder ein Krankheitsstadium zugelassen sind
    • Kürzliche Durchführung einer anderen Antitumortherapie. Hierzu zählen auch:
    o Therapie mit einem Prüfprodukt innerhalb von 30 Tagen vor der geplanten ersten Arzneimittelgabe dieser Studie
    o Bestrahlung oder andere systemische Standardtherapie innerhalb von 14 Tagen vor der geplanten ersten Arzneimittelgabe dieser Studie sowie des zusätzlichen Zeitraumes für die Rückbildung von aktuellen oder zu erwartenden Nebenwirkungen einer derartigen Bestrahlung (sofern erforderlich)
    • Herzinsuffizienz der NYHA-Klasse III oder IV oder LVEF geringer als der Normwert der Einrichtung oder < 55 %, sofern dieser nicht in den Leitlinien der Einrichtung angegeben ist. Patientinnen mit einer signifikanten Vorgeschichte von kardialen Erkrankungen (nicht eingestellter Blutdruck, instabile Angina pectoris, Myokardinfarkt innerhalb von 1 Jahr oder medikamentenpflichtige ventrikuläre Arrhythmien) sind ebenfalls ausgeschlossen
    • Schwere allergische Reaktionen gegen Paclitaxel oder andere in Cremaphor® EL enthaltene Arzneimittel, sofern die Patientin nicht nach den Leitlinien der Einrichtung desensibilisiert wurde
    • Alle anderen Erkrankungen, die nach Ermessen des Prüfarztes die Fähigkeit der Patientin beeinträchtigen könnten, die Einwilligung zu unterzeichnen, zu kooperieren und an der Studie teilzunehmen, oder die Interpretation der Studienergebnisse verfälschen könnten
    E.5 End points
    E.5.1Primary end point(s)
    PFS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 8 weeks from first dose, corresponding with the patients Recist Evaluations.
    E.5.2Secondary end point(s)
    Overall survival, ORR, CBR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    @death, and every 8 weeks from first dose, corresponding with the patients Recist Evaluations.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    Biomarker analysis
    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) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Italy
    Norway
    Spain
    United States
    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
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months33
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months33
    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 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.1.2.1Number of subjects for this age range: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 210
    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)
    Pateints to stay on trial until diesease progression, unacceptably toxicity, or death.
    Treating physicians can use their discretion on further treatment of the patient if they come off study based on the patients treatment history disease.
    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 Decision2012-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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