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    Summary
    EudraCT Number:2009-011428-79
    Sponsor's Protocol Code Number:C14008
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-07-30
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2009-011428-79
    A.3Full title of the trial
    Randomized Phase 2 Study of MLN8237, an Aurora A Kinase Inhibitor, Plus Weekly Paclitaxel or Weekly Paclitaxel Alone in Patients with Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, Preceded by a Phase 1 Portion in Patients with Ovarian or Breast Cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of MLN8237 in patients with Ovarian or Breast Cancer to find the highest safe dose of MLN8237 given in combination with Paclitaxel,
    followed by further investigation of that dose in cancers of the ovary,
    fallopian tube or peritoneum to assess the efficacy of MLN8237 plus
    paclitaxel compared to paclitaxel alone.
    A.4.1Sponsor's protocol code numberC14008
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01091428
    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 number001510740-2412
    B.5.5Fax number001800881-6092
    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 namealisertib
    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 sodium
    D.3.9.1CAS number 1208255-63-3
    D.3.9.2Current sponsor codeMLN8237-004
    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 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 6mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderHospira
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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.3.10 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
    Adenocarcinoma of the breast (Phase 1 only).

    Ovarian Cancer, defined to include recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (Phases 1 and 2).
    E.1.1.1Medical condition in easily understood language
    Breast cancer (phase 1 only)

    Cancer of the ovary, fallopian tube or the cells lining the abdominal cavity
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10058448
    E.1.2Term Peritoneal 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 14.1
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10061328
    E.1.2Term Ovarian epithelial 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 14.1
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube 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 Objectives
    The primary objectives of phase 1 are as follows:
    • To assess the safety and tolerability of alisertib (MLN8237) plus weekly paclitaxel
    • To determine the recommended dose and schedule of alisertib and dose of paclitaxel to be used as the combination treatment arm in phase 2

    Phase 2: Primary Objective

    The primary objective of Phase 2 is as follows:
    • To assess progression-free survival (PFS) after treatment with the combination of alisertib 40 mg BID for 3 days on/4 days off, repeated weekly for 3 weeks in a 28-day cycle and weekly paclitaxel 60 mg/m2 on Days 1, 8 and 15 or weekly paclitaxel 80 mg/m2 on Days 1, 8 and 15 of a 28-day cycle alone in patients with recurrent OC, and to compare PFS of the populations enrolled to these 2 treatment arms
    E.2.2Secondary objectives of the trial
    The secondary objectives of Phase 1 are:
    • To characterize the effect of concomitant administration of alisertib on the pharmacokinetics (PK) of paclitaxel
    • To characterize the PK of alisertib administered concomitantly with weekly paclitaxel
    • To assess the best overall combined response in patients with recurrent ovarian cancer (OC) or breast cancer

    The secondary objectives of Phase 2 are:
    • To estimate the overall response rate (ORR), duration of response (DOR), time to disease progression (TTP), and overall survival (OS) associated with alisertib plus weekly paclitaxel and weekly paclitaxel alone in patients with recurrent OC
    • To assess the safety and tolerability of alisertib plus weekly paclitaxel

    For additional exploratory objectives refer to the protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female patients 18 years or older.
    2. Previously treated, metastatic or locally recurrent malignancy with 1 of the 2 following diagnoses, which has been confirmed histologically or cytologically: a) adenocarcinoma of the breast (phase 1 only); or b) OC, defined to include recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (phases 1 and 2).
    3. Patients with breast cancer must have received prior treatment with at least 1 but no more than 4 prior chemotherapy regimens for locally recurrent or metastatic disease, not including regimens received in the neoadjuvant and/or adjuvant setting.
    4. In the phase 1 portion of the study, patients with breast cancer must have measurable disease (per RECIST, version 1.1; see Section 15.3 of the protocol).
    5. No antineoplastic therapy or radiotherapy within the 3 weeks before enrollment (2 weeks for regimens with recovery expected within 7 to 14 days). The patient must have recovered (ie, ≤ Grade 1 toxicity or patient’s baseline status, except alopecia) from all treatment related toxicities and must have evidence of PD or persistent disease. The patient must have experienced no more than Grade 2 non-hematologic toxicity attributed to a prior taxane therapy. No hormonal therapy except hormone replacement therapy or birth control medications.
    6. ECOG performance status (PS) of 0 or 1 (refer to Section 15.1 of the protocol).
    7. Adequate bone marrow function as defined by:
    • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 (without need for growth factor support)
    • Platelet count ≥ 100,000 cells/mm3 (without need for transfusion or growth factor support)
    • Hemoglobin level ≥ 9 g/dL
    8. Adequate liver function as defined by:
    • Bilirubin < 1.5 times the upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN if due to liver metastases)
    • serum albumin greater than the lower limit of normal (LLN)
    9. Adequate renal function as defined by:
    • Creatinine clearance ≥ 30 mL/minute (can be calculated using serum creatinine value; see Section 15.2 of the protocol)
    10. 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 ICF through 30 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
    11. The patient or the patient’s legal representative is able to provide written informed consent. 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.
    12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    13. Suitable venous access for the study-required blood sampling.

    Specific Inclusion Criteria for Patients with Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer:

    14. Prior treatments must have included a platinum and a taxane. The most recent treatment regimen (administered prior to enrollment) need not be a platinum containing or a taxane containing regimen.
    • Recurrent disease must be documented within 12 months after discontinuation of platinum therapy, based on RECIST or GCIG CA-125 criteria for disease progression described in item 15 below.
    • Patients who previously received weekly taxane are potentially eligible, provided that they did not progress during therapy or within 3 months of completing therapy.
    • Patients with platinum-refractory disease, as defined by progression during primary or subsequent platinum-based therapy or persistent radiographic disease after primary or subsequent platinum-based therapy will be included.
    15. Patients must have measurable disease in target lesions or assessable disease, and disease progression per RECIST version 1.1 (Section 15.3 of the protocol) or modified GCIG CA 125 criteria (Section 15.4 of the protocol).
    • Assessable disease is defined by CA-125 criteria as follows: minimum CA-125 level at the time of entry must have been more than 70 units/mL. This CA-125 level must have at least doubled from baseline to demonstrate evidence of PD from a previous treatment (with the value having been confirmed by at least 2 separate blood samples obtained ≥ 4 weeks apart or other clinical evidence of PD). Patients with CA-125 marker evidence for PD are included only if there is also clinical evidence of PD, eg, CT evidence for PD that is not measurable by RECIST. Radiological evidence of disease does not need to be measurable. Radiological abnormality, persistent after prior therapy, should be confirmed by biopsy to be a viable malignancy in the absence of other clinical or radiological evidence for PD.
    E.4Principal exclusion criteria
    Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

    1. Prior treatment with an Aurora A targeted agent (including alisertib).
    2. Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of alisertib and during the study. Major prohibited enzyme inducers include the following:
    • phenytoin
    • carbamazepine
    • phenobarbital
    • rifampin
    • rifabutin
    • rifapentine
    • St. John's wort
    3. Treatment with more than 4 cytotoxic chemotherapy treatment regimens in the metastatic setting. A cytotoxic agent is defined as any agent that targets the genetic, mitotic, and/or metabolic pathways of dividing cells, resulting in toxicity to the bone marrow and/or gastrointestinal mucosa. A chemotherapy regimen is defined as 1 or more agents used continuously or discontinuously (ie, allowing a break or chemotherapy holiday) without the addition of a new agent. A regimen administered pre-operatively and continued after surgery is considered a single regimen. Hormonal therapy is not considered to be a chemotherapy regimen.
    • The most recent treatment regimen need not be a platinum-containing or a taxane containing regimen.
    • Prior therapy cannot include more than 2 prior taxane-containing regimens.
    4. Current use of tamoxifen, thalidomide, or any agent used as maintenance or consolidation therapy for OC.
    5. Known hypersensitivity to Cremophor® EL, paclitaxel, or its components.
    6. Prior history of ≥ Grade 2 neurotoxicity or any toxicity requiring discontinuation from taxane chemotherapy that is not resolved to ≤ Grade 1.
    7. Any comorbid condition or unresolved toxicity that would preclude administration of weekly paclitaxel.
    8. Diagnosis of primary CNS malignancy or carcinomatous meningitis.
    9. 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.
    10. Inability to swallow PO administered medications or to maintain a fast as required before and after alisertib administration.
    11. History of hemorrhagic or thrombotic cerebrovascular event in the past 12 months.
    12. Surgery within 3 weeks before study enrollment and not fully recovered to baseline or to a stable clinical status.
    13. Diagnosis of or treated for another malignancy within 2 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type, including patients with Stage IA or IB endometrioid carcinomas, are not excluded if they have undergone complete resection.
    14. Patients who are lactating or have a positive serum pregnancy test during the screening period.
    15. Other severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study.
    16. Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids or H2 antagonists are allowed as described in Section 6.6 of the protocol.
    17. Treatment with any investigational products within 21 days before the first dose of study drug.
    18. Prior allogeneic bone marrow or organ transplantation.
    19. Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection.
    20. 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.
    21. Radiotherapy to ≥ 25% of bone marrow (Section 15.5 of the protocol), or whole pelvic radiotherapy.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1: Primary Endpoints
    The primary endpoints for the Phase 1 portion of this study include:
    • AEs, serious adverse events (SAEs), assessments of clinical and laboratory values, and vital sign measurements with a special attention to hypersensitivity reactions and neurotoxicity from the combination
    • Safe doses of MLN8237 and paclitaxel when given in combination

    Phase 2: Primary Endpoint
    The primary endpoint for the Phase 2 portion of this study includes:
    • PFS (Progression-Free Survival)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ongoing (Safety Assessments)

    Every 28 days (PFS)
    E.5.2Secondary end point(s)
    The secondary endpoints for the Phase 1 portion of this study include:
    • Best overall combined response
    • PK parameters of MLN8237, including but not limited to, maximum plasma concentration (Cmax), Tmax, and area under the plasma concentration versus time curve zero to the end of the dosing interval (AUC0-τ)
    • PK parameters of paclitaxel, including but not limited to, Cmax, AUC0-tlast, AUC0-∞, and t½, when administered alone and during concomitant administration of MLN8237

    The secondary endpoints for the Phase 2 portion of this study include:
    • ORR, DOR, TTP, and OS
    • AEs, SAEs, assessments of clinical laboratory values, and vital signs measurements
    E.5.2.1Timepoint(s) of evaluation of this end point
    The PK of paclitaxel will be characterized during Cycle 1 on Day 1 (paclitaxel administered concomitantly with MLN8237) and Cycle 2 on Day 1 (paclitaxel administered alone). Additionally, MLN8237 PK will be assessed during Cycle 1, on Days 1 and 3.

    Every 28 days (Response, lab values, vital signs)

    Ongoing (Safety Assessments)
    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 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 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
    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 years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 172
    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 Decision2012-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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