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    Summary
    EudraCT Number:2015-001234-22
    Sponsor's Protocol Code Number:NL52821.018.15
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-02
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-001234-22
    A.3Full title of the trial
    A randomized placebo-controlled study in patients with a Gallium-68 DOTATATE PET/CT positive, clinically non-functioning pituitary macroadenoma (NFMA) of the effect of Lanreotide autosolution on Tumor (adenoma) size
    Een gerandomiseerde, placebo-gecontroleerde studie onder patiënten met Gallium-68 DOTATATE PET/CT positieve, klinisch niet-functionerende hypofyse macroadenomen (NFMA) naar het effect van Lanreotide autosolution op Tumor(adenoom)grootte
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of lanreotide on non-functioning pituitary macroadenoma size
    Het effect van lanreotide op de grootte van niet-functionerende hypofyse macroadenomen
    A.3.2Name or abbreviated title of the trial where available
    GALANT
    GALANT
    A.4.1Sponsor's protocol code numberNL52821.018.15
    A.5.4Other Identifiers
    Name:Nederlands Trial RegisterNumber:NTR5275
    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 SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIpsen Farmaceutica
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointEric Fliers, principal investigator
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1100 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205666071
    B.5.5Fax number0031206917682
    B.5.6E-maile.fliers@amc.uva.nl
    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 autosolution
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Farmaceutica
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 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
    Clinically non-functioning pituitary macroadenoma
    E.1.1.1Medical condition in easily understood language
    Pituitary adenoma (tumor)
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029556
    E.1.2Term Non-secretory adenoma of pituitary
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy of lanreotide autosolution during 18 months, as compared to placebo, to reduce and/or stabilize adenoma size in patients with NFMA and positive pituitary somatostatin receptor imaging using Gallium-68 DOTATATE PET/CT.
    E.2.2Secondary objectives of the trial
    1. To assess the safety of lanreotide use in NFMA based on the number of (serious) adverse events.
    2. To compare the change in quality of life between the lanreotide autosolution 120 mg and placebo group.
    3. To compare the change in NFMA volume over 18 months between the lanreotide autosolution 120 mg and placebo group.
    4. To compare time to tumor progression (i.e. tumor growth) between the lanreotide autosolution 120 mg and placebo group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • NFMA with suprasellar extension (in previously operated patients: residual adenoma or recurrence > 10 mm)
    E.4Principal exclusion criteria
    • Hypersensitivity for somatostatin or similar peptides
    • Optic chiasm compression with visual field defects (this is an operation indication)
    • Obstructive neuroendocrine gut tumor
    • Previous radiation therapy in the pituitary region
    • Symptomatic and proven cholelithiasis
    • Use of dopamine agonists in the past 6 months
    • Use of somatostatin analogues in the past 6 months
    • Pregnancy (plans)
    • Any contraindication to perform MRI with gadolinium-based contrast agent
    E.5 End points
    E.5.1Primary end point(s)
    The change in cranio-caudal NFMA size over 18 months of lanreotide or placebo as measured on MRI (expressed in millimetes)
    E.5.1.1Timepoint(s) of evaluation of this end point
    MRI: baseline, 6 months/week 24 and at end of study after 18 months/week 72
    E.5.2Secondary end point(s)
    1. Number of adverse effects
    2. Change in quality of life
    3. Change in NFMA volume over 18 months as measured with 3DT1 MRI
    4. Time to tumor progression (i.e. tumor growth)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Adverse events can be reported throughout the study and will be specifically asked about at the visits at week 24, week 48 and week 72 (end of study)
    2. Baseline, week 24, week 48, week 72 (end of study)
    3. Same as primary endpoint: baseline, 6 months/week 24 and at end of study after 18 months/week 72
    4. Throughout the study including the predefined time points where MRI is performed
    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 No
    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 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) 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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee 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, the trial ends when the last subject has completed the last visit and pituitary MRI
    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 months6
    E.8.9.1In the Member State concerned days
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state66
    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)
    After the study is finished patients will continue with their regular follow-up appointments and examinations as before the trial. If the trial has a favourable outcome (i.e. smaller tumour size in Lanreotide users) discussion will follow if Somatuline autosolution can be registered for use in Gallium-68 DOTATATE PET-positive non-functioning pituitary macroadenoma.
    Na het einde van de studie zullen de patiënten hun reguliere behandeling hervatten in de vorm van controle afspraken en onderzoeken zoals vóór de studie. Indien de resultaten positief blijken (oftewel: afname van tumorgrootte in lanreotide gebruikers) dan zal bekeken worden of Somatuline autosolution geregistreerd kan worden voor de behandeling van Gallium-68 DOTATATE PET-positieve niet-functionerende hypofyse macroadenomen.
    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 Decision2015-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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