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    Summary
    EudraCT Number:2010-021008-77
    Sponsor's Protocol Code Number:PASIREOTIDE/01/2010
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-05-23
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-021008-77
    A.3Full title of the trial
    A MULTI - CENTER OPEN LABEL PHASE II (B) STUDY TO ASSESS EFFECTS OF SOM230 ON CARDIOVASCULAR PARAMETERS IN ACROMEGALIC PATIENTS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Acromegaly is a syndrome that results when the pituitary gland produces excess growth hormone. It most commonly affects adults in middle age. Acromegaly is often also associated with gigantism.
    A.3.2Name or abbreviated title of the trial where available
    PASIREOTIDE/01/2010 (CSOM230CSE01T)
    A.4.1Sponsor's protocol code numberPASIREOTIDE/01/2010
    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 SponsorGöteborgs Universitet, Göteborg Sweden
    B.1.3.4CountrySweden
    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 supportNovarits
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGöteborgs Universitet, Göteborg Sweden
    B.5.2Functional name of contact pointPasireotide/Akromegaly Study
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Internal Medicine, Sahlgrenska Academy at the University of Gothenburg
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code41345
    B.5.3.4CountrySweden
    B.5.4Telephone number4631741 17 14
    B.5.5Fax number463182 15 24
    B.5.6E-mailjorgen.isgaard@medic.gu.se
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/670
    D.3 Description of the IMP
    D.3.1Product namePASIREOTIDE
    D.3.2Product code SOM230
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPasireotide
    D.3.9.2Current sponsor codeSOM230
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20mg
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPasireotide
    D.3.9.2Current sponsor codeSOM230
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40mg
    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
    Adult patients 18 to 80 years of age with diagnosed acromegaly eligible for treatment with a somatostatin analogue and not on previous pharmacological treatment for acromegaly.
    E.1.1.1Medical condition in easily understood language
    Acromegalyis a syndrome that results when the pituitary gland produces excess growth hormone. It most commonly affects adults in middle age. Acromegaly is often associated with gigantism.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of pasireotide Long Acting Release (LAR )on Left Ventricle M measured with CMR at 6 months.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of pasireotide LAR on LVM after 3 months. Cardiac geometry, systolic function including ejection fraction and end-systolic volume measured with CMR after 3 and 6 months and diastolic function, including diastolic transmitral peak velocities, the E/A ratio, the isovolumic relaxation time, and mitral deceleration time measured with echocardiography after 3 and 6 months. Quantitative diastolic data will be derived from tissue Doppler imaging (TDI) analysis. Lipid profile, mean of 5 serum GH samples collected within 2 hours after one hour resting, serum IGF-I, serum IGFBP-3, glucose/insulin ratio and blood pressure measured after 3 months and after 6 months. We propose that CMR data will be assessed centrally and that IGF-I and GH will be analysed in a central lab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patients aged between 18 and 80 years.
    • Patients with active acromegaly demonstrated by
    • a lack of suppression of GH nadir to < 1 g/L after an oral tolerance test with 75 g of glucose (OGTT)
    • an elevated circulating IGF-1 concentration > 1.3 ULN (age and sex adjusted)
    • Patients who are medical treatment naïve after first surgery, or
    • de-novo patients who present with a visual adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is not indicated
    • Patients with a known history of impaired glucose metabolism may be included, however blood glucose and anti-diabetic treatment must be monitored closely throughout the trial and adjusted as necessary
    • Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity
    E.4Principal exclusion criteria
    • Previous pharmacological treatment for acromegaly
    • Uncontrolled hypertension, treated or not treated, with a diastolic blood pressure >105 mm Hg.
    • Uncontrolled diabetes mellitus as evidenced by HbA1c>8%
    • Severe liver disease (ASAT/ALAT three times upper limit of normal range laboratory values
    • Severely reduced renal function (S-creatinine >250µmol/L) or suspected renal artery stenosis.

    • QTcF at screening > 450 msec.
    • History of syncope or family history of idiopathic sudden death.
    • Sustained or clinically significant cardiac arrhythmias.
    • Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block.
    • Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
    • Concomitant medication(s) known to increase the QT interval.
    • Uncontrolled endocrine disorders
    • Pregnancy or lactation or females of childbearing potential taking inadequate measures to prevent pregnancy
    • History of or ongoing malignancy
    • Patients in a catabolic state
    • Known drug and/or alcohol abuse
    • Inability to cooperate or administer study drug
    E.5 End points
    E.5.1Primary end point(s)
    The effect of pasireotide on LVM after 6 months measured with CMR at 6 months.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA2
    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 Information not present in EudraCT
    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
    The end of study is defined as the time at which the last subject completes the end of study visit.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 20
    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 Decision2011-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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