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    The EU Clinical Trials Register currently displays   43886   clinical trials with a EudraCT protocol, of which   7296   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-020426-18
    Sponsor's Protocol Code Number:IMCLCP12-0922
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-20
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2010-020426-18
    A.3Full title of the trial
    A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study investigating new drug IMC-1121B in patients with cancer of the stomach spreading to other parts of the body - cancer does not respond to or continues to grow after standard chemotherapy (a combination of medicines including platinum or fluoropyrimidine drugs). Patients assigned to 1 of 2 groups: one group will receive IMC-1121B, the other group an inactive substance placebo. Neither patient nor doctor will know the treatment group. All patients will be treated with paclitaxel.




    A.3.2Name or abbreviated title of the trial where available
    RAINBOW
    A.4.1Sponsor's protocol code numberIMCLCP12-0922
    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 SponsorImClone LLC
    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 supportImClone Systems Corporation, a wholly-owned subsidiary of Eli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone numberN/A
    B.5.5Fax numberN/A
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameIMC-1121B
    D.3.2Product code IMC-1121B
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRamucirumab
    D.3.9.1CAS number 947 687-13-0
    D.3.9.2Current sponsor codeIMC-1121B
    D.3.9.3Other descriptive namerecombinant human IgG1 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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 Paclitaxel 6mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderEBEWE Pharma Ges.m.b.H Nfg.KG
    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.3.9.2Current sponsor code-
    D.3.9.3Other descriptive name-
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic gastric or gastroesophageal adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Cancer of stomach/oesophagus with spreading of disease to other parts of the body
    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 PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate efficacy in terms of prolonged overall survival time (OS) in patients treated with paclitaxel plus ramucirumab (IMC 1121B) drug product (thereafter referred to as ramucirumab DP) compared to patients treated with paclitaxel plus placebo as second-line treatment of metastatic gastric or gastroesophageal adenocarcinoma after failure of any platin and fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin).
    E.2.2Secondary objectives of the trial
    •To evaluate progression-free survival time (PFS) in each arm
    •To evaluate the time to progression (TTP) in each arm
    •To evaluate the best overall response (BOR) and objective response rate (ORR) in each arm
    •To evaluate the safety profile of ramucirumab DP in combination with paclitaxel
    •To evaluate patient-reported outcome (PRO) measures (EORTC QLQ-C30 and EQ-5D)
    •To examine the pharmacodynamic profile of ramucirumab DP, with exploratory analysis of pharmacodynamic biomarkers that may predict efficacy of ramucirumab DP, including but not limited to levels of circulating vascular endothelial growth factor A (VEGF-A), VEGF-B, VEGF-C, VEGF-D, placental growth factor (P1GF), soluble vascular endothelial growth factor receptor-1 (VEGFR-1), and soluble VEGFR 2
    •To assess the immunogenicity of ramucirumab DP
    •To assess pharmacokinetic parameters of ramucirumab DP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing.
    2. The patient is at least 18 years of age (or of an acceptable age according to local regulations, whichever is older).
    3. The patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry.
    4. The patient has a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma.
    5. The patient has metastatic disease or locally advanced, unresectable disease.
    6. The patient has experienced documented objective radiographic or clinical disease progression (eg, any new or worsening malignant effusion documented by ultrasound examination) which may be confirmed by pathologic criteria (histology and/or cytology) if appropriate, during first-line therapy, or within 4 months after the last dose of first-line therapy with any platinum/fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin) for unresectable or metastatic disease.
    7. The patient has resolution to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.02, of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer therapy.
    8. The patient has adequate organ function, defined as:
    • Total bilirubin ≤ 1.5 times upper limit of normal value (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN for ALAT/ASAT if no liver metastases, < 5 x ULN if liver metastases;
    • Serum creatinine ≤ 1.5 ULN or calculated creatinine clearance (per the Cockcroft-Gault formula or equivalent
    and/or 24-hour urine collection) ≥ 50 ml/min;
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, hemoglobin ≥ 9 g/dL (5.58 mmol/L; packed red blood cell
    transfusions are not permitted within one week prior to baseline hematology profile), and platelets ≥ 100 x 10^9/L; and
    • International Normalized Ratio (INR) ≤ 1.5 or Prothrombin time (PT) ≤ 1.5 x ULN
    • Partial thromboplastin time (PTT/aPTT) ≤ 1.5 x ULN.
    9. The patient’s urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates proteinuria ≥ 2+, then a 24-hour urine must be collected and must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study.
    10. The patient, if female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method (failure rate < 1%) during and for 12 weeks after the treatment period (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method). If male, the patient is surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period. The label (e.g. SmPC, USPI etc) requirements with regard to the methods and duration of contraception during and after treatment with paclitaxel can differ between countries. Country specific
    requirements will apply only if they are more stringent than those already stipulated in the protocol.
    E.4Principal exclusion criteria
    1. The patient has squamous cell or undifferentiated gastric cancer.
    2. The patient has undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to randomization.
    3. The patient has received any chemotherapy other than platinum and fluoropyrimidine with or without anthracycline for advanced gastric or GEJ adenocarcinoma.
    4. The patient has received previous systemic chemotherapy with a cumulative dose of > 900 mg/m2 of epirubicin or > 400 mg/m2 of doxorubicin.
    5. The patient has received any previous systemic therapy (including investigational agents) targeting VEGF or the VEGFR signaling pathways. Other previous targeted therapies are permitted, if stopped at least 28 days prior to randomization.
    6. The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered “significant”) during the 3 months prior to randomization.
    7. The patient is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents. Patients receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters defined in the inclusion criteria (INR ≤ 1.5 and ≤ 1.5 x ULN) or (PT ≤ 1.5 ULN and PTT/aPTT ≤ 1.5 x ULN) are met.
    8. The patient is receiving chronic therapy with nonsteroidal anti-inflammatory agents (NSAIDs, e.g., indomethacin, ibuprofen, naproxen or similar agents) or other anti-platelet agents (e.g., clopidogrel, ticlopidine, dipyridamole, anagrelide). Aspirin use at doses up to 325mg/day is permitted.
    9. The patient has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to study entry.
    10. History of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
    11. The patient has symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
    12. The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
    13. The patient has uncontrolled arterial hypertension ≥ 150 / ≥ 90 mm Hg despite standard medical management.
    14. The patient has a serious or non healing wound or peptic ulcer or bone fracture within 28 days prior to randomization.
    15. The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
    16. The patient has a serious illness or medical condition(s) including, but not limited to the following:
    • Known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
    • Active or uncontrolled clinically serious infection
    • Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the
    study
    • Uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk and/or make assessment of survival uncertain
    • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient ineligible for entry into this study
    • History or evidence of known central nervous system metastases or carcinomatous meningitis;
    • Known allergy or hypersensitivity to monoclonal antibody treatment or any components used in the ramucirumab DP preparation
    • Known allergy or hypersensitivity to paclitaxel or any components used in the paclitaxel preparation or other contraindication for taxane therapy.
    17. The patient is pregnant or breastfeeding.
    18. The patient is currently enrolled in, or discontinued within the last 28 days from a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients participating in surveys or observational studies are eligible to participate in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival time (OS)

    Overall survival time is measured as randomization to date of death from any cause.





    Safety will be evaluated based on reported adverse events, clinical laboratory assessments, vital signs and physical examinations.
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS: randomization date to event death per patient

    The final analysis will be performed once 510 OS events are observed assuming full enrollment.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:

    Progression-free survival (PFS)
    PFS is measured from randomization to the first radiographically documented progressive disease (PD) or death.

    Time to progressive disease (TTP)
    TTP is the time from randomization to the first radiographically documented progressive disease.

    Best overall response (BOR)
    Number of participants whose best response is catorgorized as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) (ver 1.1) guidelines.

    Objective response (ORR)
    Proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR) compared to the total number of participants. Best response is catorgorized using the Response Evaluation Criteria In Solid Tumors (RECIST) (ver 1.1) guidelines.

    Immunogenicity:
    Serum Anti-Ramucirumab Antibody Assessment
    Maximum concentration (Cmax) - maximum peak concentration measured in blood serum after ramucirumab infusion.

    Minimum concentration (Cmin) - minimum trough concentration measured in blood serum prior to ramucirumab infusion.

    Pharmacokinetics: Pharmacokinetic parameters, including, but not limited to: calculation of mean serum trough and peak concentrations (Cmax, and Cmin, respectively)

    Pharmacodynamics: plasma levels of circulating VEGF-A, VEGF-B, VEGF-C, VEGF-D, PlGF, soluble VEGFR-1, and soluble VEGFR-2, bFGF, and SDF1a,

    Change in [EORTC] QLQ-C30
    Change in EuroQol EQ-5D
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS, TTP and BOR:
    Imaging/tumor assessment - baseline, every 6 weeks, end of trial.

    Immunogenicity, PK, PD:
    Study day 1 - 1st ramucirumab infusion, week 6 (Cycle 2, Day 15)- 4th ramucirumab infusion, week 12 (Cycle 4, Day 1) - 7th ramucirumab infusion, and 30-37 days after last dose of study therapy

    PRO assessment:
    EORTC QLQ-C30 and EQ-5D
    Baseline, every 6 weeks, end of trial - EORTC QLQ-C30 presented first, followed by presentation of the EQ-5D









    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    European Union
    Argentina
    Australia
    Brazil
    Chile
    China
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Singapore
    Taiwan
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    •Analysis of primary endpoint performed (at least 510 deaths have been observed)
    •LPLV
    •No patient continues to receive study drug
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 442
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 221
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 273
    F.4.2.2In the whole clinical trial 663
    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)
    -
    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 Decision2010-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
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