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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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:2015-004992-62
    Sponsor's Protocol Code Number:A-US-52030-328
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-004992-62
    A.3Full title of the trial
    A PHASE 3, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, STUDY OF THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL/ DEPOT 120 MG PLUS BSC VS. PLACEBO PLUS BSC FOR TUMOR CONTROL IN SUBJECTS WITH WELL DIFFERENTIATED, METASTATIC AND/OR UNRESECTABLE TYPICAL OR ATYPICAL LUNG NEUROENDOCRINE TUMORS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumors (SPINET)
    A.3.2Name or abbreviated title of the trial where available
    SPINET
    A.4.1Sponsor's protocol code numberA-US-52030-328
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02683941
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/302/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIpsen Biopharmaceuticals, Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIpsen Pharma SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Pharma SAS
    B.5.2Functional name of contact pointSpeciality Franchise Clin Ops
    B.5.3 Address:
    B.5.3.1Street Address65 Quai George Gorse
    B.5.3.2Town/ cityBoulogne Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number003358 33 50 00
    B.5.5Fax number003358 33 50 01
    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 Yes
    D.2.1.1.1Trade name Somatuline® Autogel® 120mg
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen 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 nameSomatuline® Autogel® 120mg
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLanreotide (INN) acetate
    D.3.9.1CAS number 127984-74-1
    D.3.9.2Current sponsor codeSomatuline® Autogel®
    D.3.9.3Other descriptive nameLANREOTIDE ACETATE
    D.3.9.4EV Substance CodeSUB14326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lung Neuroendocrine Tumours
    E.1.1.1Medical condition in easily understood language
    Lung neuroendocrine tumours
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10052399
    E.1.2Term Neuroendocrine tumour
    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
    To describe the antitumour efficacy of LAN monotherapy plus BSC every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects with unresectable and/or metastatic well differentiated, typical or atypical lung neuroendocrine tumours in either the double blind phase, or in the OL period.
    E.2.2Secondary objectives of the trial
    -To describe the antitumour efficacy during the double- blind phase of LAN monotherapy plus BSC every 28 days and placebo plus BSC, in terms of progression free survival (PFS), measured by central review using RECIST v1.1 criteria, every 12 weeks, in subjects with unresectable and/or metastatic well differentiated, typical or atypical lung NETs
    -To describe the antitumour efficacy during the double- blind phase of LAN monotherapy plus BSC every 28 days and placebo plus BSC, in terms of progression free survival (PFS), measured by local review using RECIST v1.1 criteria, every 12 weeks, in subjects with unresectable and/or metastatic well differentiated, typical or atypical lung NETs
    -To describe the objective response rate (ORR) of LAN monotherapy plus BSC every 28 days and placebo plus BSC, as assessed by RECIST v 1.1 criteria (proportion of subjects with an objective response of partial response (PR) or complete response (CR)) in the double-blind phase,

    Please refer to protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Provision of written informed consent prior to any study related procedures,
    (2) Subjects aged ≥ 18 years,
    (3) Have metastasic and/or unresectable pathologically confirmed well-differentiated, typical or atypical neuroendocrine tumour of the lung,
    (4) Histologic evidence of well differentiated NETs of the lung (typical and atypical according to the WHO criteria evaluated locally),
    (5) Has a mitotic index < 2 mitoses/2 mm2 for typical carcinoid (TC) and ≤ 10 mitoses/2 mm² and/or foci of necrosis for atypical carcinoid (AC),
    (6) At least one measurable lesion of the disease on imaging (CT or MRI; RECIST v1.1),
    (7) Positive somatostatin receptor imaging (SRI) (Octreoscan® ≥ grade 2 Krenning scale; Ga-PET scan: uptake greater than liver background),
    (8) ECOG performance status 0-1,
    (9) Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required,
    (10) Female subjects who are at risk of becoming pregnant must agree to use an effective method of contraception such as double barrier contraception, an injectable, combined oral contraceptive or an intra-uterine device (IUD). The subject must agree to use the contraception during the whole period of the study and for eight months after the last study drug administration. Non childbearing potential is defined as being postmenopausal for at least 1 year, or permanently sterilized at least 3 months before study entry,
    (11) Male subjects must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception (see above). The subject must agree to use the contraception during the whole period of the study and for eight months after the last study drug administration,
    (12) Signed HIPAA authorization where required,
    (13) Subjects must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period and willing to return to the study site for the follow-up evaluation as specified in the protocol.
    E.4Principal exclusion criteria
    (1) Poorly differentiated or high grade carcinoma, or neuroendocrine tumours not of lung origin,
    (2) Subjects with multiple endocrine neoplasia type 1 (MEN 1),
    (3) Has been treated with an SSA at any time prior to randomization, except if that treatment was for less than 15 days (e.g. peri-operatively) of short acting SSA or one dose of long acting SSA and the treatment was received more than 6 weeks prior to
    randomization,
    (4) Has been treated with Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization,
    (5) Has been treated for lung NET with chemotherapy* within 4 weeks of randomization
    (whatever the number of cycles),
    (6) Has been treated with more than two lines of chemotherapy * for lung NET,
    (* cytotoxic chemotherapy or molecular targeted therapy or interferon)
    (7) Treated with surgery within 6 weeks prior to randomization,
    (8) Previous local therapy (e.g. chemo-embolization, bland, or radio-embolization) is allowed if completed > 6 weeks prior to randomization. For subjects who received local therapy prior to randomization, there must be documented growth of measurable disease within the embolization field prior to study,
    (9) Symptomatic subjects requiring SSA for symptom management (please also note the exclusion criteria No. 3),
    (10) Subjects with known ectopic production of adrenocorticotropic hormone (ACTH) or other hormonal secreting subjects allowed – ONLY if symptoms adequately controlled without SSAs,
    (11) Subjects on concomitant Growth Hormone (GH) antagonist, cyclosporine or bromocriptine
    (12) Inadequate bone marrow function as per investigator’s judgement,
    (13) Severe renal insufficiency as defined by a calculated creatinine clearance <30 mL/min,
    (14) Total bilirubin >2 x ULN, AST, ALT or Alk Ph >5xULN, lipase, amylase >2xULN,
    (15) Serum albumin <3.0 g/dL unless prothrombin time is within the normal range,
    (16) Known hypersensitivity to the study drug,
    (17) Present cholecystitis,
    (18) Uncontrolled congestive heart failure
    (19) Glycosylated hemoglobin (HbA1c) > 8.5%,
    (20) Abnormal findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, would compromise the subject’s safety or the outcome of the study,
    (21) Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years,
    (22) Pregnant or lactating women or those of childbearing potential age and not practicing a medically acceptable method for birth control,
    (23) Subjects who have participated in any therapeutic clinical study/received any investigational agent within 30 days of randomization.
    (24) Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study
    (25) Uncontrolled hypothyroidism
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) for subjects randomized in LAN group, assessed by central review using RECIST v1.1 criteria every 12 weeks, defined as the time from randomization to disease progression or death from any causes in either the double blind phase, or in the open label period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to study protocol
    E.5.2Secondary end point(s)
    -Progression-free survival (PFS), assessed by central review using RECIST v1.1 criteria every 12 weeks, defined as the time from randomization to disease progression or death from any causes during the double-blind phase,
    Progression-free survival (PFS), assessed by local review using RECIST v1.1 criteria every 12 weeks, defined as the time from randomization to disease progression or death from any causes during the double-blind phase,
    -ORR: objective response rate of CR or PR measured by RECIST v1.1 criteria every 12 weeks until the Post Treatment/Early Withdrawal Visit during the double-blind phase,
    -Time to treatment failure during the double-blind phase, defined as the time from randomization to disease progression [defined as the minimum (time to event according to central review, time to event according to local review)] using RECIST v1.1, death, consent withdrawn, an AE, protocol deviations, lost to follow-up, the appearance of carcinoid syndrome or other hormone related syndrome necessitating the initiation of SSAs (rescue octreotide and/or LAR SSA), or initiation of anticancer treatment,
    -Mean changes from Baseline in biomarker CgA at Week 8, Week 12 and every 12 weeks thereafter until the Post DB and in the OL Extension Treatment Phase,
    -Proportion of subjects with decrease in CgA ≥30% at Week 8, in the population of subjects with an elevated CgA (≥2 x ULN) at Baseline during the double-blind and the OL treatment phases,
    -Change in QoL, as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) questionnaire from Baseline to Week 12, every 12 weeks and at the Post Treatment /Early Withdrawal Visit and in OL Extension Treatment and Follow-up Phases,
    -Time to QoL deterioration, defined by a decrease from baseline in EORTC QLQ-C30 score of at least10 points during the double- blind, the OL treatment and the follow-up phases,
    -Mean changes from Baseline in urinary 5-HIAA levels at Week 8, and every 12 weeks thereafter, and at the Post Treatment/Early Withdrawal Visit and in OL Extension Treatment in subjects with elevated urinary 5-HIAA (≥2 x ULN) at Baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to study protocol
    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 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
    Quality of Life and Patient satisfaction
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Austria
    Canada
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 59
    F.4.2.2In the whole clinical trial 77
    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)
    Please refer to the protocol amendment 5.0, section 5.2.3.3 Post Treatment Visit Assessments and Procedures
    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 Decision2016-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-28
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