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    Summary
    EudraCT Number:2013-001249-15
    Sponsor's Protocol Code Number:314-12-401
    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:2013-09-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-001249-15
    A.3Full title of the trial
    A Two-Part Phase 1/2a, Open-Label, Dose-Escalation Study to Evaluate the Tolerability and Preliminary Antitumour Activity of OPB-111001 in Patients with Advanced Cancers that are Poorly Responsive to Standard Anticancer Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to determine the most suitable dose of OPB-111001 in patients with advanced cancer
    A.3.2Name or abbreviated title of the trial where available
    Study Evaluating Tolerability and Anti-tumour activity of OPB 111001
    A.4.1Sponsor's protocol code number314-12-401
    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 SponsorOtsuka Novel Products GmbH
    B.1.3.4CountryGermany
    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 supportOtsuka Novel Products GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOtsuka Novel Products GmbH
    B.5.2Functional name of contact pointClinical Program Leader
    B.5.3 Address:
    B.5.3.1Street AddressErika-Mann-Str. 21
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80636
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 89 2060205 0
    B.5.5Fax number+49 89 2060205 96
    B.5.6E-mailclinicaltrial-314-12-401@otsuka.de
    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 OPB-111001 5mg
    D.3.4Pharmaceutical form Film-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 INNNA
    D.3.9.2Current sponsor codeOPB-111001
    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 number5
    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.3.2Product code OPB-111001 25mg
    D.3.4Pharmaceutical form Film-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 INNNA
    D.3.9.2Current sponsor codeOPB-111001
    D.3.9.4EV Substance CodeAS2
    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 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 OPB-111001 100mg
    D.3.4Pharmaceutical form Film-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 INNNA
    D.3.9.2Current sponsor codeOPB-111001
    D.3.9.4EV Substance CodeAS3
    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
    • Advanced prostate cancer
    • Advanced epithelial ovarian cancer, advanced squamous cell
    carcinoma of the cervix, advanced breast cancer, endometrial
    cancer, and salivary gland cancer that are poorly responsive to
    standard treatment options
    E.1.1.1Medical condition in easily understood language
    •Advanced prostate cancer
    •Advanced epithelial ovarian cancer, advanced squamous cell carcinoma
    of the cervix, advanced breast cancer, advanced endometrial cancer &
    advanced salivary gland cancer
    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 10061934
    E.1.2Term Salivary gland 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 10060862
    E.1.2Term Prostate 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 10014733
    E.1.2Term Endometrial 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 10041848
    E.1.2Term Squamous cell carcinoma of the cervix
    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 10006187
    E.1.2Term Breast 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 10033128
    E.1.2Term Ovarian cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal objective of this clinical study is to find out how well the patients can tolerate OPB-111001 and to find the maximum tolerated dose in patients with cancer of the prostate, ovary, cervix, endometrium, breast, or salivary gland
    E.2.2Secondary objectives of the trial
    The secondary objective is to look at how the drug responds in the body when administrated to a patient and its initial effect on the type of cancer.


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patient should meet the following inclusion criteria to be considered for enrollment into the study

    1. Patients ≥18 years of age at Screening

    2. Patients with prostate cancer that is recurrent or did not respond to previous
    hormone therapy and/or who have exhausted standard treatment options.
    For the dose escalation parts only: Patients with any of the following diseases
    who have exhausted standard treatment options:

    a. recurrent or refractory ovarian cancer
    b. recurrent or refractory cervical squamous cell carcinoma
    c. recurrent or refractory breast cancer
    d. recurrent or refractory salivary gland cancer
    e. recurrent or refractory endometrial cancer

    3. Histologically or cytologically documented diagnosis of cancer

    4. Measurable disease according to Response Evaluation Criteria in Solid Tumours
    (RECIST), Version 1.1 or

    a. for prostate cancer also evaluable disease (nonmeasurable) defined as
    prostate-specific antigen progression according to Prostate Cancer Working
    Group 2 eligibility criteria
    b. for ovarian cancer also evaluable disease (nonmeasurable) according to the
    Gynaecologic Cancer Intergroup

    5. Absolute neutrophil count ≥1.5 (1500/mm3) and platelets ≥100 × 10E9/L (without
    platelet transfusion within the last 4 weeks before first study drug
    administration), and haemoglobin ≥9 g/dL at Screening

    6. Alanine aminotransferase and aspartate aminotransferase ≤2.5 × the upper limit
    of normal (ULN), Total bilirubin ≤1.5 × ULN (exception: patients with liver
    metastasis are allowed to have aspartate aminotransferase ≤5 × ULN and alanine
    aminotransferase ≤5 × ULN) at screening

    7. Albumin ≥26 g/L at Screening

    8. Estimated life expectancy >3 months (as judged by investigator)

    9. Eastern Cooperative Oncology Group performance status ≤1

    10. In prostate cancer patients: ongoing therapy with luteinizing hormone
    releasing hormone analogue or orchiectomy

    11. Agreement of female patients of childbearing potential and male patients who
    have partners capable of reproduction to use an effective double-barrier
    contraceptive method during the course of the study and for 3 months following
    the completion of their last treatment. Females of childbearing potential must
    have a negative beta-human chorionic gonadotropin pregnancy test result within
    3 days of the first study drug administration. Female patients who are
    surgically sterilized or who are >45 years old and have not experienced menses
    for >2 years may have the beta-human chorionic gonadotropin pregnancy test
    waived.

    12. Ability to understand and give written informed consent and to comply with the
    protocol (i.e., with all study-related procedures, medication use, and
    evaluations)
    E.4Principal exclusion criteria
    1. Concurrent prior treatment-related toxicity of Grade 2 or higher.
    Exception: any toxicity that is in the view of the investigator not a clinically
    significant safety risk for IMP administration.

    2. Previous treatment with cytotoxic chemotherapy or other anticancer therapy
    within 4 weeks before the first dosing with study drug (at least 6 weeks for
    mitoxantrone, nitrosurea, and bicalutamide).

    3. Treatment with systemic glucocorticosteroids of more than a 2 mg dexamethasone
    equivalent (e.g., 13 mg prednisolone) per day or in cases of treatment with ≤2
    mg dexamethasone equivalent per day:
    a. Dosing was changed within 6 weeks before Screening
    or
    b. The patient’s cancer is responding to glucocorticosteroid intake(as by
    investigator judgment)

    4. Radiation therapy within 4 weeks prior to the first dosing with IMP.

    5. Treatment with a systemic IMP in a clinical trial within 28 days before the
    Screening visit.

    6. Use of prohibited medications within 21 days of the first dose of IMP.

    7. Current or past history of clinically significant gastrointestinal disease or
    major gastrointestinal surgery, malabsorption syndrome, or other conditions that
    could interfere with enteral absorption.

    8. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New
    York Heart Association classes III to IV) or a history of ventricular arrhythmia
    requiring medication.

    9. Patients with symptomatic central nervous system metastasis.

    10. History of positive human immunodeficiency virus test result (enzyme-linked
    immunosorbent assay or Western blot)

    11. Clinical or laboratory evidence of active or chronic hepatitis B or hepatitis C
    infection.

    12. Major surgery ≤4 weeks before the first study drug administration or ongoing
    side effects of previous major surgery.

    13. Concurrent clinically significant unrelated systemic illness (e.g., serious
    infection) or significant pulmonary, hepatic, or other organ dysfunction that
    would compromise the patient’s ability to tolerate study treatment or would
    likely interfere with study procedures or results.

    14. Active treatment/chemotherapy for another primary malignancy within the past 3
    years (except for nonmelanoma skin cancer and cervical carcinoma in situ).

    15. Women who are pregnant or breastfeeding.

    16. Known or suspected hypersensitivity to the excipients (ingredients) in the
    study drug formulation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measures are the determine the safety and tolerability of OPB111001 in order to establish an MTD and recommended phase II dose. This will be achieved by monitoring the incidence of AEs (defined by NCI CTCAE V4), along with vital signs, clinical laboratory parameters and electrocardiography assessments.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) MTD/RP2D - Dose Escalation Part: After 1 or 3 cycles of treatment, Tolerability:
    Continuously
    E.5.2Secondary end point(s)
    1) Pharmacokinetic parameters for OPB-111001 and its metabolites: Area under the
    curve (AUC), maximum plasma drug concentration after single dose administration
    (Cmax), time to maximum plasma drug concentration after single dose
    administration (tmax)and terminal elimination half-life, t1/2 and for OPB-
    111001: Systemic clearance(CL/F)
    2) Assessment of antitumour activity as defined by Response Evaluation Criteria in
    Solid Tumours (RECIST), Version 1.1: complete response(CR), partial response
    (PR), stable disease (SD), objective response rate(ORR) (CR + PR)
    3) Prostate-specific antigen (PSA) response in patients with prostate cancer:
    relative change determined according to Prostate Cancer Working Group 2 (PCWG2)
    4) CA125 response in patients with ovarian cancer: relative change determined
    according to the Gynaecologic Cancer Intergroup (GCIG)
    5) Time to Treatment Failure (TTF)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1), 2), 3), 4) Repeatedly until end of study; 5) At end of study
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First part of the trial is a phase 1 dose escalation study and the second part is a phase 2a study
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end-of-trial date is defined as the last date of contact for the last patient completing or withdrawing from the trial.
    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 months0
    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 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.1.1Number 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state80
    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)
    Patients will continue to receive the study medication until disease progression or until they meet any of the other defined withdrawal criteria. No treatment will be available after the study. Patients will discuss further treatment options (best investigator's choice) or palliative care with their physician.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-09-08
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