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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2014-003878-16
    Sponsor's Protocol Code Number:B7391003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-01
    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 number2014-003878-16
    A.3Full title of the trial
    A Phase 3 randomized, double-blind study of PF-06439535 plus Paclitaxel-Carboplatin and Bevacizumab plus Paclitaxel-Carboplatin for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test if PF-06439535 plus Paclitaxel-Carboplatin compared to Bevacizumab plus Paclitaxel-Carboplatin is an effective treatment in patients with advanced non-squamous non-small cell lung cancer.
    A.4.1Sponsor's protocol code numberB7391003
    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 SponsorPfizer Inc, 235 East 42nd Street, New York, NY 10017
    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 supportPfizer Inc. 235 East 42nd Street, New Yor, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailclinicaltrials.gov_inquiries@pfizer.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 nameBevacizumab-Pfizer
    D.3.2Product code PF-06439535
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBEVACIZUMAB
    D.3.9.2Current sponsor codePF-06439535
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    D.3.11.13.1Other medicinal product typeBiosimilar medicinal product
    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 Avastin 100mg/4ml & 400mg/16ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAvastin
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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.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 non-squamous non-small cell lung cancer.
    E.1.1.1Medical condition in easily understood language
    Advanced non-squamous non-small cell lung cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the confirmed objective response rate (ORR) by Week 19 following treatment with bevacizumab-Pfizer in combination with paclitaxel and carboplatin to bevacizumab-EU plus paclitaxel and carboplatin in patients who have not received previous treatment for advanced non-squamous non-small cell lung cancer (NSCLC).
    E.2.2Secondary objectives of the trial
    To evaluate the safety of bevacizumab-Pfizer plus paclitaxel and carboplatin and
    bevacizumab-EU plus paclitaxel and carboplatin;

    To evaluate secondary measures of tumor control;

    To evaluate the population pharmacokinetics (PK) of bevacizumab-Pfizer and
    bevacizumab-EU;

    To evaluate the immunogenicity of bevacizumab-Pfizer and bevacizumab-EU.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient eligibility should be reviewed and documented by an appropriate member of the investigator’s study team before patients are included in the study.

    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

    1. Male and female patients age ≥18 years of age, or ≥ age of consent in the region.
    2. Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC).
    3. Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC.
    4. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
    5. For patients with recurrent disease, at least 6 months must have elapsed since completing adjuvant or neoadjuvant treatment.
    6. Screening scan (computed tomography [CT] or magnetic resonance imaging [MRI]) of the head, chest, abdomen (with adrenal glands), and other disease sites as clinically indicated, to assess disease burden.
    7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
    8. Screening laboratory values within the following limits (where deviation of up to 10% is acceptable for any single value if in the investigator’s opinion the patient does not have an increased safety risk):

    Bone Marrow Function

    a. Absolute neutrophil count (ANC) ≥1.5 x 10x9 cells/L (1500/mm3);
    b. Platelet count ≥100 x 10x9 cells/L (100,000/mm3);
    c. Hemoglobin ≥9.0 g/dL (90 g/L);

    Renal Function

    d. Serum or plasma creatinine ≤1.5 x upper limit of normal (ULN);
    e. Urine dipstick proteinuria <2+ (ie, either 0, trace, or 1+). If urine dipstick is >1+ then a 24 hour urine for protein must have demonstrated urinary excretion of ≤500 mg of protein per day or urine protein to creatinine ratio (UPC) ratio <1;

    Liver Function
    f. Total bilirubin ≤1.5 x ULN (<3 ULN if Gilbert’s disease);

    g. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤3 x ULN (≤5 x ULN if liver metastases are present).

    9. Recovery (to Grade 1 or baseline) from all clinically significant adverse effects of prior therapies (excluding alopecia).
    10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
    11. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    12. Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic nonsquamous NSCLC.
    13. Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use 2
    highly effective methods of contraception throughout the study and for at least 6 months after receipt of the last dose of study treatment. Female patients who are not of childbearing potential (ie, meet at least 1
    of the following criteria):
    •Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    •Have medically confirmed ovarian failure; or
    •Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating
    hormone (FSH) level confirming the post-menopausal state. All other female patients, (including females with tubal ligations) will be
    considered to be of childbearing potential.
    E.4Principal exclusion criteria
    1. Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
    2. Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed.
    3. Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations. If mutation testing is performer, results must be reviewed and confirmed as negative for mutations prior to randomization.
    4. History of other cancer within 5 years prior to screening for this study, with the exception of adequately treated ductal carcinoma in situ of the breast, cervical carcinoma in situ, or basal or squamous cell skin cancer.
    5. Prior systemic therapy for NSCLC, prior neoadjuvant/adjuvant therapy is allowed if surgical resection for primary disease was performer.
    6. History of local radiation for painful bone metastases in the last 2 weeks.(Patients with bone metastases are eligible, however those with symptomatic or painful bone metastases should not have received
    palliative local radiation for at least 2 weeks prior to randomization.)
    7. History of hemoptysis (>2.5 mL per event) in the last 3 months or severe bleeding. Evidence of current thrombotic or bleeding disorders.Therapeutic anticoagulation and/or coagulation abnormalities (eg, INR >1.5 and aPTT greater than ULN unless on prophylactic anticoagulation).
    8. Medically uncontrolled hypertension or systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg.
    9. Peripheral motor or sensory neuropathy with value of ≥ grade 2.
    10. Major surgery or any investigational agents, within 4 weeks before the administration of the first dose of study treatment. Planned major surgery during the treatment period.
    11. Any unhealed wound or bone fracture.
    12. Active infection. Patients must be off of anti-infective agents.
    13. Comorbities that would increase the risk of toxicity.
    14. Concurrent administration of other anticancer therapies. Bisphosphonate or Rank-Ligand inhibitor therapy for pre-existing bone metastases or osteoporosis is allowed.
    15. Known central nervous system (CNS) metastases, as evidenced by appropriate scans, clinical symptoms, cerebral edema, and/or progressive growth (if a suspected CNS lesion is not confirmed by pathology). Treated and stable (asymptomatic; off steroids) brain metastases are allowed.
    16. Active uncontrolled cardiac disease, such as cardiomyopathy, congestive heart failure (CHF) New York Heart Association (NYHA) functional classification of ≥3, unstable angina, or myocardial infarction within 12 months before first dose of study treatment. Clinically significant cardiovascular disease, peripheral vascular disease, transient ischemic attack, cerebrovascular accident.
    17. History of severe hypersensitivity reaction to any of the products to be administered during the study, including mammalian cell derived drug products, taxanes, bevacizumab, murine proteins, or excipients in their formulations.
    18. Clinical contraindication to treatment with steroids preventing use as part of paclitaxel premedication.
    19. Pregnant female patients; breastfeeding female patients; male patients with partners currently pregnant; patients able to father
    children and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study, and for at least 6 months
    after receipt of the last dose of study treatment.
    Note: For female patients of childbearing potential, to exclude the possibility of pregnancy, a serum or urine pregnancy test with sensitivity of at least 25 mIU/mL will be performed on 2 occasions by the local
    certified laboratory, and 2 negative tests are required before receiving the first dose of investigational product. The second negative test should be done during the first 5 days of the period, immediately preceding the
    first dose of any study treatment. In the absence of regular menstrual bleeding, the patient should have used 2 different methods of contraception for at least 1 month before the second pregnancy test. A patient is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active. This
    includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
    Please see the protocol for exclusion criterias 20-25.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR), evaluating the best response achieved by Week 19 and subsequently confirmed by 6 weeks thereafter, in accordance with Response Evaluations Criteria in Solid Tumors (RECIST) version 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 19 and subsequently confirmed by 6 weeks thereafter.
    E.5.2Secondary end point(s)
    • Safety characterized by type, incidence, severity, timing, seriousness, and relationship to study therapy of adverse events, including cardiotoxicity and infusion-related reactions, and laboratory abnormalities at 1 year from randomization;

    • Duration of response (DOR), 1 year progression-free survival (PFS) rate and 1-year survival rate and 1-year survival rate from randomization;

    • Peak and trough bevacizumab-Pfizer and bevacizumab-EU concentrations at selected cycles up to 1 year from randomization;

    • Incidence of anti-drug (bevacizumab) antibodies (ADA), including neutralizing antibodies (NAb) up to 1 year from randomization.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 Year
    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 No
    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) 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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA140
    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
    Argentina
    Australia
    Brazil
    Chile
    Croatia
    Czech Republic
    France
    Germany
    Greece
    Hong Kong
    Hungary
    India
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Netherlands
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    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
    EoT in an EUMemberState is defined as the time at which it is deemed that a sufficient number of patients have been recruited and completed the study as stated in the regulatory application.The study is completed at the LVLS.
    EoT in all other participating countries is defined as the time at which the last patient has completed LVLS at which time study objectives have been met and the study completed.
    LVLS is defined as up to 1 year from randomization of the last patient plus 28days follow-up.
    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 months1
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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: 391
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 319
    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 state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 304
    F.4.2.2In the whole clinical trial 710
    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 who discontinue all study treatment should be evaluated for safety for at least
    28 (+7) days after last dose.
    After discontinuation of treatment, patient survival status will be collected by telephone contact every 2 months ± 14 days until death or 1 year from patient randomization and at least 6 months following receipt of the last dose of study treatment, which ever is longer.
    Information on subsequent anti-cancer treatments received will be collected during long-term follow-up.
    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 Decision2015-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-12
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