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    Summary
    EudraCT Number:2012-001338-32
    Sponsor's Protocol Code Number:NFPA12
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2012-05-10
    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 ConcernedNorway - NOMA
    A.2EudraCT number2012-001338-32
    A.3Full title of the trial
    Dopamine agonist treatment of non-functioning pituitary adenomas (NFPAs) - a randomized controlled trial. The efficacy of cabergoline on tumour volume in previously untreated macroadenomas or residual adenomas after pituitary surgery or irradiation.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dopamine agonist treatment of non-functioning pituitary adenomas - a randomized controlled trial.
    A.3.2Name or abbreviated title of the trial where available
    Dopamine agonist treatment of non-functioning pituitary adenomas
    A.4.1Sponsor's protocol code numberNFPA12
    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 SponsorSt. Olavs Hospital Trondheim University Hospital
    B.1.3.4CountryNorway
    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 supportSt. Olavs Hospital Trondheim University Hospital
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt. Olavs Hospital Trondheim University Hospital
    B.5.2Functional name of contact pointDepartment of Endocrinology
    B.5.3 Address:
    B.5.3.1Street AddressPostboks 3250 Sluppen
    B.5.3.2Town/ cityTrondheim
    B.5.3.3Post code7006
    B.5.3.4CountryNorway
    B.5.4Telephone number4772825120
    B.5.5Fax number4772825407
    B.5.6E-mailstine.fougner@ntnu.no
    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 Dostinex and Cabaser
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer AS
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 namecabergoline
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    non-functioning pituitary adenomas
    E.1.1.1Medical condition in easily understood language
    pituitary tumours with no hormone production
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10035079
    E.1.2Term Pituitary adenoma
    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 study the effect of medical treatment with cabergoline on tumour volume in non-functioning pituitary adenomas.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of medical treatment with cabergoline in non-functioning pituitary adenomas on pituitary function, and on the need for non-medical treatment. To evaluate possible complications to dopamine agonist treatment in non-functioning pituitary adenomas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A previously untreated non-functioning pituitary macroadenoma (largest diameter ≥ 10 mm) OR a residual tumour after surgical treatment of a non-functioning pituitary macroadenoma
    2. Age 18-75 years
    E.4Principal exclusion criteria
    1. Clear indication for surgery at the time of inclusion
    2. Radiation therapy the last 2 years prior to inclusion, or radiation therapy >2 years earlier if significant tumour shrinkage after treatment
    3. Pituitary surgery the last 6 months
    4. Apoplexy/bleeding in the adenoma
    5. Pregnancy or lactation
    6. Contraindications for cabergoline treatment:
    Known cardiac valvular disease
    Known pulmonal, pericardial or retroperitoneal fibrosis
    Clinical significant liver insufficiency
    Use of medications that interact with cabergoline
    7. Unfit to participate due to any other reason
    E.5 End points
    E.5.1Primary end point(s)
    The change in tumour volume during the study. This includes the percentage and absolute change in tumour volume, but also the number of patients with significant tumour shrinkage or tumour growth.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 2 years (at cross-over) and 4 years (end of study).
    Interim analyses will be performed after one year to ensure and document safety.
    E.5.2Secondary end point(s)
    • The need for surgical and/or radiation treatment during the study period.
    • The development of new or changed pituitary failure during the study, or new or changed visual field defects or other cranial nerve affections.
    • The change in tumour’s distance to chiasma opticum (mm).
    • The response on gonadotropins (FSH, LH) and/or their subunits, particularly the α-subunit. We will also examine a possible correlation between the tumour size response and the hormone levels and hormone response during treatment.
    • The development of cardiac valvulopathy
    • The development of impulse control disorder.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 2 years (at cross-over) and 4 years (end of study).
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    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 Yes
    E.8.2.3.1Comparator description
    observation
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    End of clinical phase of trial: the last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 45
    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 state80
    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)
    Post-trial treatment will be the standard treatment and follow-up for patients with non-functioning pituitary adenomas
    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 Decision2012-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-30
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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