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    Summary
    EudraCT Number:2016-000084-16
    Sponsor's Protocol Code Number:NC-6004-004A
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-25
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2016-000084-16
    A.3Full title of the trial
    A Phase 1b/2 Dose Escalation and Expansion Trial of NC-6004 (Nanoparticle Cisplatin) plus Gemcitabine in Patients with Advanced Solid Tumors or Squamous Non-Small Cell Lung, Biliary Tract, and Bladder Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Medical Treatment of Advanced Solid Tumors or Squamous Non-Small Cell Lung, Biliary Tract, and Bladder Cancer
    A.4.1Sponsor's protocol code numberNC-6004-004A
    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 SponsorNanoCarrier Co, Ltd
    B.1.3.4CountryJapan
    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 supportNanoCarrier Co, Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD, Inc.
    B.5.2Functional name of contact pointIlaria Bottesini
    B.5.3 Address:
    B.5.3.1Street Address929 North Front Street
    B.5.3.2Town/ cityWilmington, N.Carolina
    B.5.3.3Post code28401-3331
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1910251-0081
    B.5.5Fax number+1919516-0733
    B.5.6E-maililaria.bottesini@ppdi.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 nameNanoparticle Cisplatin
    D.3.2Product code NC-6004
    D.3.4Pharmaceutical form 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 INNNot available
    D.3.9.2Current sponsor codeNC-6004
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    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: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gemcitabine 1g Powder for Solution for Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    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.3.1Product nameGemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGemcitabine
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 solid tumors and first-line metastatic squamous NSCLC; first-line metastatic or locally advanced cholangiocarcinoma, gallbladder cancer, or ampullary cancer (biliary tract cancer); and first-line metastatic or locally advanced transitional cell carcinoma (TCC) of the urinary tract (bladder cancer).
    E.1.1.1Medical condition in easily understood language
    Cancer of Lung, bladder cancer, biliary tract cancer, advanced solid tumors.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10005003
    E.1.2Term Bladder 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 20.0
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10017614
    E.1.2Term Gallbladder 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
    In the expansion phase of the study (Part 2), to evaluate the activity of NC-6004 in combination with gemcitabine in patients with first-line Stage IV squamous NSCLC, first-line advanced or metastatic biliary tract cancer, and first-line metastatic or locally advanced bladder cancer compared with historical control as measured by local investigator/radiologist-assessed progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
    E.2.2Secondary objectives of the trial
    - To evaluate ORR, DCR (DCR = complete response [CR] + partial response [PR] + stable disease [SD]), DOR, PFS, and OS;
    - To evaluate therapy-related AEs;
    - To evaluate the safety and tolerability of NC-6004 when combined with gemcitabine;
    - To evaluate QoL using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30);
    - To evaluate acute and delayed symptoms using the MD Anderson Symptom Inventory (MDASI) and a nausea and vomiting patient diary.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide signed written informed consent prior to the initiation of any study-specific procedures.
    2. Cohort 1: Have histologically or cytologically confirmed diagnosis of Stage IV squamous NSCLC and have not received prior chemotherapy or
    immunotherapy for metastatic disease and are not known to be PD-L1 positive. Patients with known sensitizing mutation in the epidermal
    growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene must have received at least 1 and up to 2 targeted therapies prior to enrollment.
    - A patient with stable, treated brain metastases is eligible, provided that there is no evidence of progression after treatment and the patient
    does not require corticosteroids, or, if the patient requires corticosteroid, has been receiving a stable dose of corticosteroids for at least 14 days prior to assignment to treatment.
    - Patients whose tumors are known to harbor an exon 19 deletion or exon 21 L858R EGFR mutation must have had intolerance or have progressed on at least 1 and up to 2 EGFR tyrosine kinase inhibitors. Cohort 2: Have histologically or cytologically confirmed diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma) and have not received prior systemic anticancer therapy for advanced or metastatic disease. Cohort 3: Have histologically or cytologically confirmed diagnosis of
    metastatic or locally advanced TCC of the urinary tract (bladder, urethra, ureter, renal pelvis) (T3b-T4 N0 M0, Tany N1-N3 M0, or Tany Nany M1)
    and are not candidates for surgery.
    - Patients must not have received prior treatment with systemic anticancer therapy for metastatic or locally advanced urinary tract cancer.
    - Certain mixed histologies that are predominantly (>50%) TCC are eligible: squamous, adenocarcinoma, and undifferentiated.
    3. Have measurable disease per RECIST version 1.1.
    4. Are males or females aged ≥18 years.
    5. Have an ECOG PS of 0 to 1, with the exception of patients in Part 2 (Cohort 3, unfit bladder cancer patients) who may have an ECOG PS of 2.
    6. Have adequate bone marrow reserve defined as:
    - Absolute neutrophil count of at least 1.5 × 109/L,
    - Platelet count of at least 100 × 109/L, and
    - Hemoglobin level of 10 g/dL (transfusion is allowed to achieve hemoglobin level of at least 10 g/dL).
    7. Have adequate liver function defined as:
    - Total serum bilirubin <1.5 × upper limit of normal (ULN) and
    - Baseline alanine transaminase, and aspartate transaminase <2.0 × ULN or, in patients with documented hepatic metastasis ≤5.0 × ULN and
    Serum albumin ≥3.5 g/dL.
    8. Prothrombin time within normal limits
    9. Have a negative pregnancy test result at screening (for females of childbearing potential; not applicable to patients who are unable to become pregnant, including those with bilateral oophorectomy and/or hysterectomy or postmenopausal [no menses for the previous 12 months]).
    10. Male patients must agree to use a condom during treatment and for 90 days after dosing.
    11. For women of childbearing potential*: are willing to follow 1 of the following effective methods of birth control from the time of study entry to 6 months after the last day of treatment:
    • Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
    • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)
    • Intrauterine devices
    • Intrauterine hormone-releasing system
    • Vasectomized partner who has received medical assessment of surgical success
    • Bilateral tubal occlusion
    • True sexual abstinence**
    *Patients not of childbearing potential include those who are surgically sterile or postmenopausal (no menses for the previous 12 months). For women not currently taking contraceptive methods at screening, low user-dependency contraceptive methods (eg, implantable progestogen-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner) are recommended.
    **The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
    12. Have reasonably recovered from preceding major surgery as judged by the investigator or have had no major surgery within 4 weeks prior to Day 1 treatment.
    E.4Principal exclusion criteria
    1. Have received prior platinum therapy in the past 3 months (Part 1) or 6 months in the adjuvant or neoadjuvant setting (Part 2).
    2. Have received prior cisplatin and gemcitabine concomitantly within the last 6 months or are refractory to cisplatin and gemcitabine.
    3. Are unable to receive platinum-based therapy due to previous toxicity.
    4. Have unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment, with the exception of alopecia and ≤Grade 1 peripheral neuropathy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 (National Cancer Institute 2010). Clinical judgment by the investigator is allowed to determine if Grade 1 fatigue at
    screening is residual toxicity from prior treatment or is a symptom of the patient’s general condition or disease. The investigator and Medical Monitor will discuss the eligibility of patients with baseline toxicity.
    5. Have evidence suggesting pulmonary fibrosis or interstitial pneumonia.
    6. Have a history of thrombocytopenia with complications including hemorrhage or bleeding of ≥Grade 2 according to the NCI CTCAE version 4.03 that required medical intervention or have any hemolytic condition or coagulation disorders that would make participation unsafe in the opinion of the investigator.
    7. Have known hypersensitivity to platinum compounds or gemcitabine.
    8. Have uncontrolled diabetes or have hypertension requiring more than 3 medications for control of hypertension.
    9. Have known active hepatitis B (defined as a known positive hepatitis B surface antigen [HBsAg] result) or hepatitis C (defined by a known positive hepatitis C antibody result or known quantitative HCV RNA results greater than the lower limits of detection of the assay).
    10. Are pregnant or breast-feeding.
    11. Have signs or symptoms of organ failure, major chronic illnesses other than cancer, or any concomitant medical or social conditions that, in the opinion of the investigator, make it undesirable for the patient to participate in the study or that could jeopardize compliance with the protocol.
    12. Have pre-existing alcoholic liver injury or significant liver disease.
    13. Are regularly consuming alcohol within 6 months of Screening defined as an average weekly intake of >21 units (or an average daily intake of >3 units) for males or >14 units (or an average daily intake >2 units) for females. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine, or 1 measure (25 mL) of spirits.
    14. Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy.
    15. Are unwilling or unable to comply with study procedures or are planning to take a vacation for 7 or more consecutive days during the treatment phase of the study without prior consent from the Medical Monitor.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. will be continuously updated and compared with the historical PFS from Phase 3 pivotal cisplatin and gemcitabine trials within each cohort. The PFS hazard model will be updated as PFS data accrue. A hazard ratio (HR) for PFS for each cohort versus historical control will be obtained.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression-free survival will be defined as the time from first dose of study product until the first date of either disease progression or death due to any cause and will be evaluated for each dose level and for all patients in the FAS. The date of disease progression will be defined as the earliest date of radiological disease progression as assessed by the investigator using RECIST version 1.1 or clinical disease progression. For patients who have not progressed or died at the time of the analysis, censoring will be performed using the date of the last adequate disease assessment. Once 10 PFS events have been observed, interim analyses will be performed every 6 weeks. At each interim and at the final analysis, there are 3 possible outcomes for each cohort.
    E.5.2Secondary end point(s)
    The exploratory endpoints of this study include exploratory safety endpoints of the occurrence of AEs and SAEs after 6 cycles of treatment and the following PK endpoints for micellar platinum in plasma and total platinum in plasma and plasma ultrafiltrate calculated for all patients using noncompartmental analysis:
    Cmax (maximum concentration)
    Tmax (time to maximum concentration)
    AUClast (area under the concentration-time curve from time zero to the last quantifiable concentration)
    AUC0-τ (area under the concentration-time curve from time zero to the end of the dosing interval)
    AUC0-∞ (area under the concentration-time curve from time zero to infinity)
    AI (accumulation index)
    Vss (volume of distribution at steady-state)
    MRT (mean residence time)
    λz (terminal elimination phase rate constant)
    T½ (terminal half-life)
    CL (clearance)
    Vz (volume of distribution)
    - Safety endpoints:
    The safety endpoints for this study are the incidence and severity of AEs and laboratory abnormalities, according to the NCI CTCAE version 4.03, the occurrence of SAEs and treatment discontinuations due to AEs, and nausea severity and vomiting incidence obtained from the patient diary.
    - Efficasy analysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic plasma and plasma ultrafiltrate will be collected at the following times in Part 2 for up to 6 cycles:
    • Before the start of the NC-6004 infusion on Day 1
    • At the end of NC-6004 infusion
    • Before gemcitabine infusion on Day 8
    • At End-of-Treatment visit
    Adverse events will be evaluated at each visit during every cycle and graded according to the NCI CTCAE.
    Disease response assessment will occur every 6 weeks until disease progression.
    Quality of life will be assessed before treatment on Day 1 and Day 8 of each cycle and at the End-of-Treatment visit using the EORTC QLQ-C30.
    Symptoms will be assessed before treatment on Day 1 and Day 8 of each cycle and at the End-of-Treatment visit using the core MD Anderson Symptom Inventory
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Bulgaria
    Italy
    Poland
    Romania
    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
    The duration of the study for each patient is defined as the time from the date of signed written informed consent through the End-of-Treatment visit or until death.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days15
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 160
    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)
    None
    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 Decision2016-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-21
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