Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-003798-25
    Sponsor's Protocol Code Number:MM-111-13-02-04
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-01-07
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-003798-25
    A.3Full title of the trial
    Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel with or
    without Trastuzumab in Patients with ‘Traditional’ and ‘Non-Traditional’ HER2 Expressing Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of MM-111 and Paclitaxel with or without Trastuzumab in patients with Metastatic or Locally Advanced Cancer of the Esophagus, Gastroesophageal Junction and Stomach
    A.3.2Name or abbreviated title of the trial where available
    Open Label MM-111 in patients with HER2
    A.4.1Sponsor's protocol code numberMM-111-13-02-04
    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
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressOne Kendall Square, Suite B7201
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 617 4417667
    B.5.5Fax number001 617 8128419
    B.5.6E-mailsfrye@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.3.1Product nameMM-111
    D.3.4Pharmaceutical form 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 INNMM-111
    D.3.9.2Current sponsor codeMM-111
    D.3.9.3Other descriptive namebispecific antibody which binds to ErbB2 and ErbB3 receptors
    D.3.9.4EV Substance CodeAS1
    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 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 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: 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.2.1.1.1Trade name Paclitaxel
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf.
    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 namePaclitaxel
    D.3.2Product code L01CD01
    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.3.9.3Other descriptive namePaclitaxel
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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.2.1.1.1Trade name Herceptin
    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 nameHerceptin
    D.3.2Product code L01XC03
    D.3.4Pharmaceutical form 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 INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.2Current sponsor codeTrastuzumab
    D.3.9.3Other descriptive namerhuMAb HER2, Anti-HER
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2-4
    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 Yes
    D.3.11.13.1Other medicinal product typeTrastuzumab (Herceptin) is a recombinant humanized IgG1 kappa monoclonal antibody
    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
    HER2 distal esophageal, Gastroesophageal (GE) junction or gastric carcinoma.
    E.1.1.1Medical condition in easily understood language
    Cancer of the esophagus, gastroesophageal (GE) junction or stomach.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10015362
    E.1.2Term Esophageal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10056267
    E.1.2Term Gastroesophageal 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
    The primary objective of the study is to compare the Progression Free Survival (PFS) between the experimental and comparator arms within two distinct patient populations: Patients with ‘Traditional’ and ‘Non-Traditional’ HER2 expressing tumors.
    E.2.2Secondary objectives of the trial
    To compare the following measures between the two treatment arms within each group:

    - Overall Survival (OS)
    - Time to treatment failure (TTF)
    - Objective response rate
    - Duration of Response (DOR)
    - Safety Profiles
    - Health-Related Quality of Life (HRQOL) scores

    To evaluate the following in treatment arm regimens that include MM-111:

    - Pharmacokinetic (PK) profile and pharmacodynamic activity of MM-111 in distal esophageal, GE junction, and gastric carcinoma
    - Immunogenicity of MM-111 when administered in combination with paclitaxel with/without trastuzumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be qualified for study participation based on the following inclusion criteria:

    - Patients must have documentation of histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or stomach
    - Patients must have documentation of histologically or cytologically confirmed HER2
    expression as follows:
    o Traditional HER2 Group 1: Patients who are HER2 3+ by IHC OR HER 2 2+ by IHC and HER2 gene amplified by FISH or CISH
    o Non-Traditional HER2 Group 2: Patients who are HER2 2+ by IHC and HER2 gene nonamplified by FISH or CISH
    - For Traditional HER2 Group 1
    o Patients must have received one prior systemic therapy for metastatic disease, which must be a standard fluoropyrimidine/platinum-based frontline therapy given with or without trastuzumab
    - Non-Traditional HER2 Group 2
    o Patients must have received one prior systemic therapy for metastatic disease which must be a standard fluoropyrimidine/platinum-based frontline therapy given without trastuzumab
    - Patients must be ≥18 years of age
    - Patients or their legal representatives must be able to understand and sign an informed consent
    - Patients should have evaluable or measurable disease ≥1 cm per RECIST 1.1
    - Patients must have ECOG PS of 0, 1, or 2
    - Patients must have adequate hematologic status as evidenced by:
    o Absolute neutrophil count (ANC) ≥1500 cells/mm3
    o Platelet count ≥100,000 platelets/mm3
    o Hemoglobin ≥9 g/dL
    - Patients must have adequate hepatic function as evidenced by:
    o Serum total bilirubin ≤1.5 × the upper limit of normal (ULN)
    o Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤2.5 x ULN (5 × ULN is acceptable if liver metastases are present)
    - Patients must have adequate renal function as evidenced by:
    o Serum creatinine ≤1.5 × ULN or calculated clearance 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
    - Patients must be recovered from the effects of any prior surgery, radiotherapy or other
    antineoplastic therapy. NCI CTCAE v.4.0 up to grade 1 is acceptable for patients with preexisting peripheral neuropathy
    - Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use an effective form of contraception during the study and for 6 months following the last dose of assigned study drug(s)
    - Patients must have an archived formalin-fixed, paraffin-embedded (FFPE) tumor tissue
    sample
    - Patients must be willing and able to undergo a pre-treatment biopsy (this applies to the first
    30 patients in each treatment group i.e. 30 for Traditional HER2 and 30 for Non-Traditional
    HER2)
    E.4Principal exclusion criteria
    Patients will be disqualified from study participation based on the following exclusion criteria:
    - Patients for whom potentially curative antineoplastic therapy is available
    - Patients who previously received paclitaxel or other taxane treatment in the frontline or locally advanced setting
    - Patients who are pregnant or lactating
    - Patients with an active infection or with 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)
    - Patients with known brain metastasis
    - Patients with known hypersensitivity to any of the components of MM-111 or who have had
    hypersensitivity reactions to fully human monoclonal antibodies
    - Patients with a known history of hypersensitivity to paclitaxel or other drugs formulated in
    Cremophor® EL, unless a patient has been de-sensitized in accordance with institutional
    guidelines
    - Patients with a known history of hypersensitivity to trastuzumab or any of its components
    (for group 1 only)
    - Patients who have received other recent anti-tumor therapy. This includes the following:
    o Investigational therapy administered within the 28 days prior to the first scheduled day of dosing MM-111
    - Dosing within <28 days since receiving investigational therapy is acceptable once a time interval equal to at least five half-lives of the investigational agent has passed
    - Patients in the Traditional HER2 group already receiving trastuzumab do not require a wash-out period from trastuzumab (for group 1 only)
    o Any standard chemotherapy or radiation or other therapy within 14 days prior to the
    first scheduled dose of MM-111
    o Patients who have not recovered from clinically significant effects of any prior surgery, radiotherapy or any other antineoplastic therapies. Patients with a known peripheral neuropathy must present with a grade 1 severity or less according to NCI CTCAE 4.0
    Patients with active or prior history of New York Heart Association (NYHA) congestive heart failure or left ventricular ejection fraction (LVEF) <50%
    - History of myocardial infarction within 12 months of enrollment
    - Uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure
    >100 mm Hg)
    - Known angina pectoris requiring medication
    - Known clinically significant heart valve disease
    - Known history of high-risk arrhythmias requiring medical attention (chronic stable well controlled atrial fibrillation is permissible)
    - Active gastrointestinal bleeding
    - Patients who have received prior maximum cumulative anthracycline doses:
    o Doxorubicin or liposomal doxorubicin doses >360 mg/m2
    o Mitoxantrone >120 mg/m2 and idarubicin >90 mg/m2
    o Epirubicin doses higher than 720 mg/m2
    o Other (e.g., liposomal doxorubicin or other anthracycline equivalent of 360 mg/m2 of doxorubicin)
    o If more than 1 anthracycline has been used, the cumulative dose must not exceed the equivalent of 360mg/m2 of doxorubicin
    - Patients with known human immunodeficiency virus (HIV). Patients with Hepatitis B surface antigen (carriers) may be enrolled but must receive nucleoside/nucleotide analogue or other suitable treatment for Hepatitis B per institutional guidelines
    - Patients with any other medical or psychological condition, deemed by the investigator to
    likely interfere with a patient’s ability to sign informed consent or cooperate and participate
    in the study, or interfere with the interpretation of the study results
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) is the primary efficacy endpoint.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS is defined as the number of months from the date of randomization to the date of death or progression, whichever occurred earlier.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints that will be used to evaluate target and non-target lesion antitumor response of each treatment regimen using RECIST v1.1 criteria include:
    - Overall Survival (OS)
    - Time to treatment failure (TTF)
    - Objective response rate
    - Duration of Response (DOR)
    - Safety profiles will also be analyzed
    - Health-Related Quality of Life (HRQOL) scores

    The following will be assessed in treatment arm regimens that include MM-111:
    - Pharmacokinetic (PK) concentrations and pharmacodynamic activity of MM-111 in distal esophageal, GE junction, and gastric carcinoma Immunogenicity of MM-111 when administered in combination with paclitaxel
    with/without trastuzumab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Death (i.e. overall survival)
    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 Yes
    E.6.10Pharmacogenetic No
    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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Denmark
    France
    Korea, Republic of
    Spain
    South Africa
    Taiwan
    United Kingdom
    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
    Date when all subjects are deceased.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    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 months9
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 180
    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)
    Physicians choice, there are no restrictions. Note: there is no 3rd line options for these patients
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Sarah Cannon Research Institute
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-05-29
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 02 01:22:47 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA