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    Summary
    EudraCT Number:2008-006981-27
    Sponsor's Protocol Code Number:C14007
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-26
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2008-006981-27
    A.3Full title of the trial
    A Phase 1 Dose Escalation Study of MLN8237, an Aurora A Kinase Inhibitor, in Adult Patients With Nonhematological Malignancies, Followed by a Phase 2 of MLN8237 in Lung, Breast, Head and Neck, or Gastroesophageal Malignancies.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of MLN8237 in patients with solid tumor cancers to find the highest does of MLN8237 followed by further investigation of that dose in cancers of the lung, breast, head and neck or the gastic/oesphagus region.
    A.4.1Sponsor's protocol code numberC14007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01045421
    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 SponsorMillennium 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 supportMillennium Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc
    B.5.2Functional name of contact pointDrug Information Call Center
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne St
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number0015107402412
    B.5.5Fax number0018008816092
    B.5.6E-mailmedical@mlnm.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 nameMLN8237
    D.3.2Product code MLN8237
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNalisertib
    D.3.9.1CAS number 1208255-63-3
    D.3.9.2Current sponsor codeMLN8237
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 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 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 nameMLN8237
    D.3.2Product code MLN8237
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNalisertib
    D.3.9.1CAS number 1208255-63-3
    D.3.9.2Current sponsor codeMLN8237
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 nameMLN8237
    D.3.2Product code MLN8237
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNalisertib
    D.3.9.1CAS number 1208255-63-3
    D.3.9.2Current sponsor codeMLN8237
    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.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
    Phase I portion of the study - Advanced nonhematologic malignancies.

    Phase II portion of the study - Non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), adenocarcinoma of the esophagus/gastroesophageal junction or stomach, head and neck carcinoma, or adenocarcinoma of the breast.
    E.1.1.1Medical condition in easily understood language
    MLN 8237 is being developed as a possible treatment for patients with advanced solid tumours ( such as lung cancer, breast cancer etc.) whose disease is no longer responding to standard therapies
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10041067
    E.1.2Term Small cell lung 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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10006173
    E.1.2Term Breast adenocarcinoma
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung 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 16.0
    E.1.2Level PT
    E.1.2Classification code 10001150
    E.1.2Term Adenocarcinoma gastric
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck 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
    Phase 1: The primary objective of the phase 1 portion of this study is to assess the safety and tolerability of MLN8237, formulated as an enteric-coated tablet (ECT), on a 7-day dosing schedule for determining the recommended dose and schedule of MLN8237 to be used in phase 2.

    Phase 2: The primary objective of the phase 2 portion of this study is to estimate the antitumor activity of MLN8237 as measured by overall response rate (ORR) in patients with advanced, unresectable nonhematological malignancies (NSCLC, SCLC, adenocarcinoma of the breast, HNSCC, or adenocarcinoma of the esophagus/gastroesophageal junction or stomach).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the phase 1 portion of this study are:

    - To characterize the PK of MLN8237, formulated as ECT (Enteric Coated Tablet), administered on a 7-day dosing schedule.
    - To describe any antitumor activity that may be observed with MLN8237 treatment in patients with advanced nonhematological malignancies.
    - To determine the RP2D-P (Recommended Phase 2 Dose - Pancreatic) in a subset of patients who meet eligibility criteria for the pancreatic cancer patient cohort.

    The secondary objectives of the phase 2 portion of this study are:

    - To assess the relationship between clinical response and molecular markers of response.
    - To assess additional measures of antitumor activity, including TTP, PFS, and DOR.
    - To characterize the safety profile associated with MLN8237.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients 18 years or older.
    2. Patients must have a diagnosis of an advanced, unresectable solid tumor that is histologically or cytologically confirmed to be of 1 of the following types, and for which standard curative or life-prolonging treatment does not exist, or is no longer effective or tolerable. Enrollment to the phase 1 portion is not restricted by tumor histology, however, an expansion cohort will include patients with adenocarcinoma of the pancreas, described below. Enrollment to the phase 2 portion requires 1 of the following histologic types:
    - Group 1: Non-small cell lung cancer (NSCLC). Including 8 to 10 patients with predominant squamous cell histology, with 6 patients enrolled prior to evaluation for futility.
    - Group 2: Small-cell lung cancer, extensive-stage (SCLC). A minimum of 8 and maximum of 12 patients with SCLC and chemotherapyrefractory disease, defined as no response to first-line chemotherapy or relapse within 90 days after completion of first-line chemotherapy.
    - Group 3: Invasive adenocarcinoma of the breast (female patients only). Including 8 to 10 patients with disease known to be basal-like intrinsic subtype (also ER, PR, and HER2 negative) and 8 to 10 patients with disease known to be HER2 positive with any ER, PR. For ER, PR, and HER2 negative, the following criteria apply:
    - Estrogen receptor (< 10%)
    - Progesterone receptor (< 10%)
    - HER-2 (negative FISH, IHC 0 - 1+, or IHC 0 - 2+ with negative FISH)
    Group 4: Squamous cell cancer of the head and neck cancer (HNSCC). A minimum of 8 and maximum of 12 patients with disease originating in the tonsillar or base of tongue area will be enrolled in the first stage, and this subgroup must have archival tumor available for analysis of HPV16 and HPV18.
    - Group 5: Adenocarcinoma of the esophagus, gastroesophageal junction, or stomach.
    3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
    4. Female patients who:
    - Are postmenopausal for at least 1 year before the screening visit, OR
    - Are surgically sterile, OR
    - If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form (ICF) through 30 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
    Male patients, even if surgically sterilized (ie, status post-vasectomy), who:
    - Agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study drug, OR
    - Agree to completely abstain from heterosexual intercourse.
    5. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
    6. Clinical laboratory values as specified below:
    - Total bilirubin ≤ 1.5 times the upper limit of normal (ULN).
    - Alanine aminotransferase (ALT) and AST must be ≤ 3.0 times the ULN. AST and ALT may be elevated up to 5 times the ULN if the elevation can be reasonably ascribed to their underlying cancer or liver metastases.
    - Calculated creatinine clearance ≥ 30 mL/minute.
    - Platelet count ≥ 75,000/mm3 without transfusion requirement.
    - Absolute neutrophil count (ANC) ≥ 1500/mm3 without the need for growth factor support.
    7. Measurable disease as per RECIST, version 1.1 (Only required for enrollment to the phase 2 part of the study)
    8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
    9. Patients in the pancreatic cancer patient cohort will have the following features:
    a) prior history of regional treatment for adenocarcinoma of the pancreas (prior treatment may include pancreatectomy or Whipple surgical procedure, partial [but not total] gastrectomy, or regional radiotherapy); and b) concomitant treatments with pancreatic enzymes and proton pump inhibitor.
    E.4Principal exclusion criteria
    1. Female patients who are lactating or have a positive serum pregnancy test during the screening period.
    2. Other severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study.
    3. Receipt of more than 2 previous cytotoxic chemotherapeutic regimens (4 previous regimens for breast cancer) in the setting of metastatic or recurrent disease, not including regimens used as adjuvant or neo-adjuvant therapies if completed 6 months prior to subsequent chemotherapy. There is no limit on the number of prior noncytotoxic therapies (eg, hormonal, immunological, or biological) that patients may have received. Tyrosine kinase inhibitors (eg, Tarceva® and Iressa®) are considered to be noncytotoxic compounds if their dominant toxicity profile does not include sustained effects on normal proliferating tissues or bone marrow.
    4. Prior treatment with Aurora A-targeted agents, including MLN8237.
    5. Prior treatment with high-dose chemotherapy, defined as chemotherapy requiring the use of peripheral blood or bone marrow stem cell support for hematopoietic reconstitution.
    6. Prior allogeneic bone marrow or other organ transplantation.
    7. Systemic antineoplastic treatment within 21 days preceding the first dose of MLN8237. Patients treated with noncytotoxic small molecule drugs (see exclusion criteria in the protocol for examples) must not have received treatment with these drugs for at least 2 weeks before the first dose of MLN8237 is administered. Exceptions requiring a 42-day recovery period from last treatment are listed in the exclusion criteria in the protocol.
    -The patient must have recovered (ie, ≤ Grade 1 toxicity or patient’s baseline status,
    (except alopecia) from all treatment-related toxicities to be eligible for the study.
    8. Radiotherapy to ≥ 25% of bone marrow.
    9. Concurrent investigational treatment or treatment with any investigational products within 21 days before the first dose of study drug.
    10. Patient has symptomatic brain metastasis. Patients with brain metastases must:
    - Have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks after completion of the definitive therapy, and be without neurologic dysfunction that would confound the evaluation of neurologic and other AEs.
    11. Diagnosis of or treatment for another malignancy within 2 years before the first dose of study drug except for nonmelanoma skin cancer that has been completely resected, or any in situ malignancy that has been completely resected.
    12. Myocardial infarction within 6 months of enrollment or current history of New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
    13. Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinically significant.
    14. Major surgery within 14 days prior to the first dose of study drug treatment.
    15. Infection requiring systemic intravenous antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection.
    16. Inability to swallow oral medication or to maintain a fast as required before and after MLN8237 administration.
    17. History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease.
    18. Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion.
    19. Patients requiring full systemic anticoagulation (excluding low-dose aspirin, or low-dose anticoagulation to maintain patency of venous access devices). Low molecular weight heparin is allowed if the patient has tolerated treatment with a stable dose and schedule without bleeding complications for more than 1 month.
    20. Treatment with clinically significant enzyme inducers (see protocol exclusion criteria for examples) within 14 days prior to the first dose of MLN8237 and during the study.
    21. The following eligibility restrictions will apply to patients other than patients enrolled to the pancreatic cancer cohort: malabsorption, resection of pancreas or upper small bowel, requirement for pancreatic enzymes, or any condition that would modify small bowel absorption or oral medications. These exclusion criteria may be modified based on results obtained from evaluation of the pancreatic cancer patient cohort.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1: Primary Endpoint
    The primary endpoints for the phase 1 portion of this study include AEs, serious adverse events (SAEs), assessments of clinical and laboratory values, ECGs, and vital sign measurements.

    Phase 2: Primary Endpoint
    The primary endpoint for the phase 2 portion includes ORR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the database is locked to Final Analysis. Final analysis is when the final set of tables, listing and figures are available. Timepoint of evaluation for both endpoints is anticipated to occur March 2014.
    E.5.2Secondary end point(s)
    The secondary endpoints for the phase 1 portion of this study include:

    PK parameters of MLN8237, including but not limited to, Cmax, Tmax,
    and area under the plasma concentration versus time curve zero to the
    end of the dosing interval on Days 1 and 7, and terminal half-life on Day
    7 for a 7-day BID dosing schedule.

    Response, according to RECIST 1.1, in patients with measurable disease.
    The secondary endpoints for the phase 2 portion include:
    TTP, PFS, and DOR.

    AEs, SAEs, assessments of clinical laboratory values, ECGs, and vital
    signs measurements.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the database is locked to Final Analysis. Final analysis is when the
    final set of tables, listing and figures are available. Timepoint of
    evaluation for both endpoints is anticipated to occur March 2014.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial5
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Czech Republic
    France
    Poland
    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 patient, last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-11-26. Yes
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 270
    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 Decision2011-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-25
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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