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    Summary
    EudraCT Number:2006-004111-22
    Sponsor's Protocol Code Number:CSOM230B2305
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-004111-22
    A.3Full title of the trial
    A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230)s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing`s disease
    Studio in doppio cieco, randomizzato per valutare la sicurezza e l`efficacia di dosi differenti di pasireotide (SOM230) s.c. in pazienti con morbo di Cushing de novo, persistente o ricorrente trattati per 6 mesi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    //
    //
    A.4.1Sponsor's protocol code numberCSOM230B2305
    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 SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOVARTIS FARMA
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityORIGGIO
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number02-96541
    B.5.5Fax number02-9659066
    B.5.6E-mailinfo.studiclinici@novartis.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 namepasireotide
    D.3.2Product code SOM230B
    D.3.4Pharmaceutical form Solution for injection
    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 INNpasireotide
    D.3.9.1CAS number 396091-77-3
    D.3.9.2Current sponsor codeSOM230B
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.3Concentration number900
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 2
    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 namepasireotide
    D.3.2Product code SOM230B
    D.3.4Pharmaceutical form Solution for injection
    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 INNpasireotide
    D.3.9.1CAS number 396091-77-3
    D.3.9.2Current sponsor codeSOM230B
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.3Concentration number600
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 3
    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 namepasireotide
    D.3.2Product code SOM230B
    D.3.4Pharmaceutical form Solution for injection
    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 INNpasireotide
    D.3.9.1CAS number 396091-77-3
    D.3.9.2Current sponsor codeSOM230B
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.3Concentration number300
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    de novo or persistent/recurrent Cushing disease
    Morbo di Cushing de novo, persistente o ricorrente
    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 PT
    E.1.2Classification code 10011652
    E.1.2Term Cushing's syndrome
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy in terms of response to pasireotide 600 µg s.c. b.i.d. and 900 µg s.c. b.i.d. independently in patients with Cushing`s disease as measured by UFC `‰¤1.5 X ULN and `‰¥50% reduction of urinary free cortisol (UFC) from baseline after 6 months of treatment
    Valutare l`efficacia di pasireotide in termini di risposta al trattamento con 600 µg s.c. due volte al giorno e 900 µg s.c. due volte al giorno in maniera indipendente in pazienti affetti da morbo di Cushing mediante la misurazione dell`UFC `‰¤ 1.5 x ULN e la riduzione dell`UFC `‰¥ 50% dopo 6 mesi di trattamento rispetto al basale.
    E.2.2Secondary objectives of the trial
    `To assess censor-adjusted response `To assess pooled dose response `To assess median UFC response `To assess time to response `To assess the response by dose group `To assess normalization of UFC at 6 months `To assess the effect of pasireotide s.c. on plasma ACTH and serum cortisol `To assess improvement in clinical signs: blood pressure, body mass index, waist circumference and weight reduction `To assess improvement in clinical symptoms of Cushing`s disease: depression, facial rubor, supraclavicular and dorsal fat pads, hirsutism, striae, muscle strength, bone density and body composition `To assess the effect of pasireotide s.c. on Quality of Life `To determine the pharmacokinetics of pasireotide after s.c. b.i.d. administration
    Valutare la risposta aggiustata per i dati censored-Valutare la risposta alle dosi pooled-Valutare la risposta UFC mediana-Valutare il tempo alla risposta-Valutare la risposta per dose-Valutare la normalizzazione dell`UFC a 6 mesi-Valutare l`effetto di pasireotide s.c.sull`ACTH plasmatico e sul cortisolo sierico misurati in termini di variazione percentuale rispetto al basale per gruppo di trattamento-Valutare il miglioramento dei segni clinici: pressione arteriosa,indice di massa corporea,circonferenza della vita e riduzione del peso-Valutare il miglioramento della sintomatologia clinica del morbo di Cushing: depressione,rubor facciale,adipe sopraclavicolare e dorsale,irsutismo,strie rubre,forza muscolare,densita` ossea e composizione corporea-Valutare l`effetto di pasireotide sulla qualita` della vita-Determinare la farmacocinetica di pasireotide dopo somministrazione sottocutanea due volte al giorno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    `Male or female patients aged 18 years or greater `Patients with confirmed diagnosis of ACTH-dependent Cushing`s disease, as evidenced by (1) mean UFC from two 24-hour urinary collections at least two times the upper limit of the laboratory normal range collected within 2 weeks; (2) morning plasma ACTH within the normal or above normal range; (3) either MRI confirmation of pituitary macroadenoma (greater than or equal to 1 cm) or inferior petrosal sinus gradient >3 after corticotrophin-releasing hormone (CRH) or for patients who have had prior pituitary surgery, documentation confirming an ACTH staining adenoma (an MRI is also required). This diagnosis must be verified within 2 months prior to study entry `Patients with de novo Cushing`s disease can be included only if they are not considered candidates for pituitary surgery (poor surgery candidates, surgically unapproachable tumors, patients who refuse to have surgical treatment) `Karnofsky performance status `‰¥60 (i.e. requires occasional assistance, but is able to care for most of this personal needs) `For patients on medical treatment for Cushing`s disease the followingassessments are performed `Inhibitors of steroidogenesis - ketoconazole, metyrapone, rosiglitazone: 1 week `Dopamine agonists - bromocriptine, cabergoline: 4 weeks `Octreotide LAR and Lanreotide autogel: 8 weeks `Lanreotide SR: 4 weeks `Octreotide - immediate release formulation: 1 week
    Entrambi i sessi ed eta` `‰¥ 18 anni -Diagnosi confermata di morbo di Cushing ACTH dipendente comprovata da -Livelli medi di cortisolo libero urinario di due raccolte delle 24 ore effettuate entro due settimane almeno due volte &gt; il limite superiore del range di normalita` del laboratorio -ACTH plasmatico del mattino `‰¥ il range di normalita` -Conferma alla RMN del microadenoma ipofisario (`‰¥ 1 cm) o gradiente sinusale petroso inferiore &gt; 3 dopo stimolazione con CRH per i tumori di dimensione &lt; 1 cm o, per i pazienti con che sono stati precedentemente sottoposti a chirurgia ipofisaria, esame istopatologico positivo per adenoma ACTH (e` richiesta anche la RMN) -I pazienti con morbo di Cushing de novo possono essere inclusi solo se non sono candidabili ad intervento chirurgico ipofisario (vedi Sez. 5 del protocollo di studio) -Karnofsky performance status `‰¥ 60 (cioe` che richiede assistenza occasionale ma e` in grado di badare alle proprie necessita`) -Per i pazienti con m. di Cushing in terapia medica deve essere eseguito il seguente periodo di wash-out prima di completare le valutazioni basali: -Inibitori della steroidogenesi (ketoconazolo, metirapone, rosiglitazone) : 1 settimana -Agonisti della dopamina (bromocriptina, cabergolina) : 4 settimane -Lanreotide SR: 4 settimane -Octreotide (formulazioni a pronto rilascio): 1 settimana
    E.4Principal exclusion criteria
    `Patients who have received pituitary irradiation, as the onset time of the radiation effects can not be determined `Patients who have been treated with mitotane during the last 6 months `Patients with compression of the optic chiasm causing any visual field defect, in order to exclude patients with a tumor causing chiasma compression requiring surgery `Patients with Cushing`s syndrome due to ectopic ACTH secretion `Patients with hypercortisolism secondary to adrenal tumors or Nodular (primary) bilateral adrenal hyperplasia `Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1) `Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA) `Patients who are not biochemically euthyroid `Patients who have undergone major surgery within 1 month `Patients with symptomatic cholelithiasis `Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as evidenced by HbA1C >8% `Patients with abnormal coagulation (PT or PTT elevated by 30% above normal limits) `Patients receiving anticoagulants that affect PT or PTT `Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, symptomatic bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function `Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with ALT/AST more than 2 X ULN, serum creatinine >2.0 X ULN, serum bilirubin >2.0 X ULN, serum albumin >1.5 X ULN
    `Precedente irradiazione dell`ipofisi, poiche` il momento dell`insorgenza degli effetti dell`irradiazione non puo` essere identificato precisamente `Terapia con mitotano nei 6 mesi precedenti la Visita 1 `Compressione del chiasma ottico che causa qualunque difetto del campo visivo, per escludere i pazienti con tumore che causa compressione del chiasma che richiede l`intervento chirurgico `Sindrome di Cushing dovuta a secrezione ectopica di ACTH `Ipercortisolismo secondario a tumore surrenalico o iperplasia surrenalica bilaterale nodulare (primitiva) `Sindrome ereditaria nota come causa di ipersecrezione ormonale (complesso di Carney, sindrome di McCune-Albright, MEN-1) `Iperaldosteronismo glucocorticoide-sensibile (GRA) `Non eutoroidismo biochimico `Intervento chirurgico maggiore nel mese precedente l`inizio dello studio `Colelitiasi sintomatica `Diabetici in terapia antidiabetica con glicemia a digiuno poco controllata (HbA1c &gt;8) `Alterazioni della coagulazione (PT o PTT &gt;30% rispetto al limite di norma) `Terapia anticoagulante che ha impatto su PT e PTT `Scompenso cardiaco (classe NYHA III o IV), angina instabile, tachicardia ventricolare protratta, bradicardia clinicamente significativa, blocco cardiaco avanzato, anamnesi positiva per infarto miocardico acuto in un periodo inferiore ad un anno precedentemente all`ingresso nello studio o alterazione clinicamente significativa della funzione cardiovascolare `Epatopatia, come cirrosi, epatite cronica attiva o epatite cronica persistente, o livelli di AST/ALT &gt; 2 x ULN, creatininemia &gt; 2 x ULN, bilirubinemia &gt; 2 x ULN, albuminemia &gt;1.5 x ULN
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients in each independent treatment arm with `‰¤1.5 X ULN and `‰¥50% reduction in UFC from baseline at 6 months
    La proporzione di pazienti che al mese 6, in ogni braccio di trattamento indipendente, ha UFC `‰¤ 1.5 x ULN e una riduzione `‰¥ 50% di UFC rispetto al basale.
    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 Yes
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    randomizzazione a diverse dosi di pasireotide
    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.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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 concerned9
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months47
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months47
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 69
    F.4.2.2In the whole clinical trial 100
    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 Decision2006-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-21
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