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    Summary
    EudraCT Number:2010-020394-17
    Sponsor's Protocol Code Number:ARD11585(MM-121-01-101)
    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:2011-07-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-020394-17
    A.3Full title of the trial
    A Phase 1-2 trial of MM-121 in Combination with Erlotinib in Three Groups of Patients with Non-Small Cell Lung Cancer
    Ensayo de fase 1-2 de MM-121 combinado con erlotinib en tres grupos de pacientes con cáncer de pulmón no microcítico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to determine wether adding a new drug to an existing treatment is safe and helps people with lung cancer
    Ensayo para determinar si añadiendo un nuevo fármaco a un tratamiento ya existente es seguro y ayuda a personas con cáncer de pulmón
    A.4.1Sponsor's protocol code numberARD11585(MM-121-01-101)
    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 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
    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 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 Yes
    D.2.1.1.1Trade name TARCEVA 25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameErlotinib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.4EV Substance CodeSUB21050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name TARCEVA 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameErlotinib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.4EV Substance CodeSUB21050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name TARCEVA 150 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameErlotinib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.4EV Substance CodeSUB21050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Patients with Non-Small Cell Lung Cancer
    pacientes con cáncer de pulmón no microcítico
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    Cáncer de pulmón
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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
    Primary Phase 1 Objective :
    ? To assess the safety of the MM-121 + erlotinib
    combination
    ? To determine the recommended Phase 2 doses of
    the MM-121 + erlotinib combination

    Primary Phase 2 Objective:
    To estimate the Progression Free Survival (PFS) of the MM-121 + erlotinib combination in three distinct groups of patients with non-small cell lung cancer
    Objetivo principal de la fase 1:
    • Determinar la seguridad de la combinación MM-121 + erlotinib.
    • Determinar las dosis recomendadas para la fase 2 de la combinación MM-121 + erlotinib.
    Objetivo principal de la fase 2:
    Estimar la supervivencia libre de progresión (SLP) de la combinación MM-121 + erlotinib en tres grupos distintos de pacientes con cáncer de pulmón de células no pequeñas
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    ? To describe the dose limiting toxicity of the MM-
    121 + erlotinib combination
    ? To determine the adverse event profile of the MM-
    121 + erlotinib combination
    ? To determine the pharmacokinetic parameters and
    immunogenicity of the MM-121 + erlotinib combination

    ? To obtain an initial estimate of other key efficacy
    endpoints (objective response rate, disease control
    rate, overall survival and overall PFS) in this
    population for use in planning subsequent
    randomized phase 2/3 trials
    ? To gather exploratory clinical data on a potentially
    predictive set of biomarkers to be measured in
    serum and tumor tissue
    Objetivos secundarios:
    • Describir la toxicidad limitante de dosis de la combinación MM-121 + erlotinib.
    • Determinar el perfil de acontecimiento adverso de la combinación MM-121 + erlotinib.
    • Determinar los parámetros farmacocinéticos y la inmunogenia de la combinación MM-121 + erlotinib.
    • Obtener una estimación inicial de otros criterios clave de valoración de la eficacia (tasa de respuesta objetiva, tasa de control de la enfermedad, supervivencia total y SLP total) en esta población, para su uso en la planificación de los ensayos de fase 2/3 con distribución aleatoria posteriores.
    • Recopilar datos clínicos exploratorios sobre un conjunto de biomarcadores potencialmente predictivos medidos en suero y en el tejido tumoral.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with locally advanced or metastatic non-small cell lung cancer.
    - Patients must be >/= 18 years of age.
    - Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.
    • Los pacientes deben tener confirmado por métodos histológicos o citológicos un cáncer de pulmón de células no pequeñas localmente avanzado o metastásico.
    • Los pacientes deben ser ≥ 18 años.
    • Los pacientes deben tener un estado adecuado de la actividad en la escala ECOG y una adecuado funcionamiento de los órganos.
    E.4Principal exclusion criteria
    - Patients with a recent history (within 5 years) of another malignancy.
    - Patients who are pregnant or nursing.
    - Patients with clinically significant heart failure.
    - Patients with clinically significant eye or gastrointestinal abnormalities.
    • Pacientes con una historia reciente (dentro de los últimos 5 años) de otra malignidad.
    • Pacientes que estén embarazadas o amamantando
    • Pacientes con insuficiencia cardíaca congestiva clínicamente significativa.
    • Pacientes con anormalidades oftalmológicas o gastrointestinales clínicamente significativas
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: To determine the recommended Phase 2 dose of the MM-121 + erlotinib combination based upon either the maximum tolerated dose (MTD) or the maximum feasible dose of the combination in patients with NSCLC.

    Phase II: To estimate the progression-free survival of the MM-121 + erlotinib combination in patients with NSCLC
    Fase I: Determinar la dosis recomendada para la Fase II de la combinación de MM-121 + erlotinib basándose en la dosis máxima tolerada (MTD) o en la máxima dosis viable de la combinación en pacientes con NSCLC

    Fase II: Estimar la supervivencia libre de progresión de de la combinación de MM-121 + erlotinib en pacientes con NSCLC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I : June 2011
    Fase I: Junio 2011
    E.5.2Secondary end point(s)
    - To describe the dose limiting toxicity of the MM-121 + erlotinib combination

    - To determine the adverse event profile of the MM-121 + erlotinib combination

    - To determine the pharmacokinetic parameters and immunogenicity of the MM-121 + erlotinib combination

    - To obtain an initial estimate of other key efficacy endpoints (objective response rate, disease control rate, overall survival and overall PFS) in this population for use in planning subsequent randomized phase 2/3 trials

    - To gather exploratory clinical data on a potentially predictive set of biomarkers to be measured in serum and tumor tissue
    - Describir la dosis limitante de toxicidad de la combinación MM-121 + erlotinib.
    - Determinar el perfil de seguridad de la combinación MM-121 + erlotinib.
    - Determinar los parámetros farmacocinéticas y de inmunogenicidad de la combinación de MM-121 + erlotinib.
    - Obtener una estimación inicial de otros objetivos claves de eficacia (tasa de respuesta objetiva, tasa de control de la enfermedad, supervivencia global y supervivencia libre de progresión global) en esta población para ser utilizados en próximos ensayos planeados aleatorizados fases 2/3.
    - Reunir datos clínicos exploratorios de un grupo de potenciales biomarcadores predictivos para ser medibles en plasma y tejido tumoral.
    E.5.2.1Timepoint(s) of evaluation of this end point
    December 2012
    Diciembre 2012
    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
    Exploratory clinical data on a potentially predictive set of biomarkers
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    Germany
    Hong Kong
    Korea, Democratic People's Republic of
    Spain
    Taiwan
    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
    It is intended that subjects will be treated until disease
    progression or intolerable toxicity. Following treatment
    discontinuation, subjects will be followed for overall
    survival status until the subject expires or until 1 year after
    the enrollment of the last subject within the respective
    cohort, whichever occurs first.
    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 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: 154
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 229
    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)
    Not Applicable
    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 Decision2011-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
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