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    Summary
    EudraCT Number:2011-002912-10
    Sponsor's Protocol Code Number:CH-ACM-01
    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:2012-03-29
    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 number2011-002912-10
    A.3Full title of the trial
    EFFICACY AND SAFETY OF ORAL OCTREOLIN™ IN PATIENTS WITH ACROMEGALY WHO ARE CURRENTLY RECEIVING PARENTERAL SOMATOSTATIN ANALOGS
    Efficacia e sicurezza di Octreolin™ orale in pazienti con acromegalia attualmente trattati con analoghi della somatostatina per via parenterale.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY AND SAFETY OF ORAL OCTREOLIN™ IN PATIENTS WITH ACROMEGALY
    Efficacia e sicurezza di Octreolin™ orale in pazienti con acromegalia.
    A.4.1Sponsor's protocol code numberCH-ACM-01
    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 SponsorCHIASMA, 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 supportCHIASMA, INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace, Inc.
    B.5.2Functional name of contact pointMedpace Regulatory Submissions
    B.5.3 Address:
    B.5.3.1Street AddressGmunder Strasse 53
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81379
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 89 895 57 180
    B.5.5Fax number+49 89 895 57 18100
    B.5.6E-mailregsubmissions@medpace.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 nameOctreolin
    D.3.2Product code NA
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.2Current sponsor codeOctreolin
    D.3.9.3Other descriptive nameOCTREOTIDE ACETATE
    D.3.9.4EV Substance CodeSUB03490MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Acromegaly
    Acromegalia
    E.1.1.1Medical condition in easily understood language
    Acromegaly is a chronic metabolic disorder in which there is too much growth hormone and the body tissues gradually enlarge.
    Acromegalia è un disordine metabolico cronico in cui c'è troppo ormone della crescita e i tessuti corporei gradualmente s'ingrandiscono.
    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 SOC
    E.1.2Classification code 10014698
    E.1.2Term Endocrine disorders
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of Octreolin therapy on Insulin-like Growth Factor 1 (IGF-1) levels
    Determinare l'effetto della terapia a base di Octreolin sui livelli del Fattore di crescita insulino-simile 1 (IGF-1)
    E.2.2Secondary objectives of the trial
    To determine the effect of Octreolin therapy on Growth Hormone (GH) levels To assess the safety and tolerability of Octreolin in subjects with acromegaly
    Determinare l'effetto della terapia a base di Octreolin sui livelli di ormone della crescita (GH) Valutare la sicurezza e la tollerabilità di Octreolin in pazienti con acromegalia
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOKINETIC/PHARMACODYNAMIC:
    Vers:1.2
    Date:2011/06/30
    Title:Pharmacokinetic Sub-Study
    Objectives:Determine the PK profile of Octreolin during chronic treatment
    FARMACOCINETICA/FARMACODINAMICA:
    Vers:1.2
    Data:2011/06/30
    Titolo:Sottostudio di farmacocinetica
    Obiettivi:Determinare il profilo farmacocinetico di Octreolin durante il trattamento cronico
    E.3Principal inclusion criteria
    1. Adult subjects, aged 18 to 75 years old, inclusive, at screening visits 2. Subjects with acromegaly defined as documented evidence of GH-secreting pituitary tumor that is abnormally responsive to glucose who are currently receiving regular monthly parenteral injections for at least 3 months and are considered complete responders or at least partial responders to a somatostatin analog: o Eligible somatostatin analogs includes: octreotide (sc and LAR), lanreotide (LA, Autogel or Depot) o Complete response is defined as: IGF-1 normalized for age and integrated GH response over 2 hours < 2.5 ng/mL o Partial response is defined as: IGF-1 < 30% above level normalized for age (i.e., < 1.3 times the upper limit of normal) and integrated GH response over 2 hours < 2.5 ng/mL o Age-normalized IGF-1 will be considered the 2.5th to 97.5th percentile range for the central reference laboratory. Local laboratory values will not be used to qualify patients for the study o Subjects taking regular injections of somatostatin analogs less frequently than monthly will not be eligible o Subjects taking injections of octreotide on an as-needed basis to treat headaches will not be eligible 3. Subjects receiving appropriate stable doses of hormone replacement therapy for ≥3 months 4. Subjects able and willing to comply with the requirements of the protocol 5. Subjects able to swallow capsules 6. Subjects able to understand and sign written informed consent to participate in the study
    1. Pazienti adulti, di età tra 18 e 75 anni inclusi, al momento delle visite di screening 2. I pazienti con acromegalia definita con evidenza documentata di tumore pituitario secernente GH normalmente reattivo al glucosio che ricevono iniezioni parenterali mensili su base regolare da almeno 3 mesi e siano considerati rispondenti completi o almeno rispondenti parziali a un analogo della somatostatina: o Gli analoghi della somatostatina idonei includono: octreotide (sc e LAR), lanreotide (LA, Autogel o Depot) o La risposta completa viene definita come: IGF-1 normalizzato per età e la risposta di GH integrata nell’arco di 2 ore &lt; 2,5 ng/mL o La risposta parziale viene definita come: IGF-1 &lt; 30% al di sopra del livello normalizzato per età (ossia, &lt; 1,3 volte il limite superiore al normale) e risposta di GH integrata nell’arco di 2 ore &lt; 2,5 ng/mL o L’IGF-1 normalizzato per età sarà considerato l’intervallo da 2,5° a 97,5° percentile per il laboratorio di riferimento centrale. I valori di laboratorio locali non saranno usati per qualificare i pazienti per lo studio o I pazienti che assumono regolarmente iniezioni di analoghi della somatostatina con una frequenza inferiore a quella mensile non sono ritenuti idonei o I pazienti che assumono iniezioni di octreotide secondo necessità per trattare le cefalee non sono ritenuti idonei 3. I pazienti che hanno ricevuto appropriate dosi stabili di terapia ormonale sostitutiva per ≥3 mesi 4. I pazienti capaci e disposti a collaborare per soddisfare i requisiti del protocollo 5. I pazienti capaci di ingerire capsule 6. I pazienti capaci di comprendere e firmare il consenso informato scritto a partecipare allo studio
    E.4Principal exclusion criteria
    1. Symptomatic cholelithiasis 2. Received pituitary radiotherapy within ten years prior to screening 3. Undergone pituitary surgery within the prior 6 months 4. High-risk pattern of pituitary tumor location on brain MRI 5. Clinically significant GI, renal or hepatic disease as determined by the Principal Investigator. Conditions significantly affecting gastric acidity or emptying will typically exclude patients (e.g., bariatric surgery). Current use (within 1 month) of proton pump inhibitors (PPIs) and current chronic use of H2-antagonists will exclude subjects 6. Known allergy or hypersensitivity to any of the test compounds or materials 7. Life expectancy of less than 2 years 8. Uncontrolled diabetes defined as having a fasting glucose > 150 mg/dL (8.3 mmol/L) or HbA1c ≥ 8% (Patients can be rescreened after diabetes is brought under adequate control); For Afro-Caribbeans, Fructosamine (marker of glucose tolerance) level of >288 mmol/L 9. Defects in visual fields due to optic chiasmal compression or other neurological signs, related to the pituitary tumor mass. Subjects with long-standing (>12 months), fixed, minor defects may be considered on a case-by-case basis after consultation with the Medical Monitor 10. Active, clinically significant cardiac disease, including sustained arrhythmia, at time of screening 11. History of unstable angina or acute myocardial infarction within the three months preceding study screening 12. Female patients who are pregnant or lactating 13. Female patients who are of childbearing potential with a positive pregnancy test at screening or baseline or who not practicing an acceptable method for birth control. Acceptable methods include intrauterine devices, or mechanical methods (e.g., vaginal diaphragm, vaginal sponge or condom with spermicidal jelly), sexual abstinence or a vasectomized partner. Oral contraceptives are not permitted. Women may be surgically sterile or at least 1 year post-last menstrual period 14. History of immunocompromise, including a positive HIV test result (ELISA and Western blot) 15. Undergone major surgery/surgical therapy for any cause within 4 weeks prior to randomization 16. Hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or steroid hormone replacement therapy for ≥ 3 months 17. History of alcohol or drug abuse 18. Any condition that may jeopardize study participation (e.g., clinically significant abnormal screening clinical or laboratory finding during screening), the interpretation of study results or may impede the ability to obtain informed consent (e.g., mental condition) 19. Intake of an investigational drug within 30 days before patient inclusion in this study 20. Current or recent (< 3 months) therapy with pegvisomant 21. Current or recent (< 2 months) therapy with cabergoline
    1. Colelitiasi sintomatica 2. Somministrazione di radioterapia pituitaria entro dieci anni prima dello screening 3. Essere stati sottoposti a chirurgia pituitaria entro i precedenti 6 mesi 4. Schema di localizzazione di tumore pituitario ad alto rischio sulla RMI del cervello 5. Patologie del tratto GI, renali o epatiche clinicamente significative determinate dallo Sperimentatore principale. Condizioni che influiscono significativamente sull’acidità gastrica o sullo svuotamento escluderanno tipicamente i pazienti (ad es., chirurgia bariatrica). Uso corrente (entro 1 mese) di inibitori della pompa protonica (PPI) e uso corrente cronico di antagonisti di H2 escluderanno i pazienti 6. Allergia o ipersensibilità note a uno qualsiasi dei composti o materiali del test 7. Aspettativa di vita inferiore a 2 anni 8. Diabete non controllato definito come avente un glucosio a digiuno &gt; 150 mg/dL (8,3 mmol/L) o HbA1c ≥ 8% (I pazienti possono essere sottoposti nuovamente a screening dopo che il diabete è stato riportato sotto controllo); Per gli afro-caraibici, livello di fruttosamina (marker della tolleranza al glucosio) &gt;288 mmol/L 9. Difetti del campo visivo dovuti a compressione del chiasma ottico o altro segno neurologico, correlato alla massa tumorale pituitaria. I pazienti con difetti minori, fissi, di lunga durata (&gt;12 mesi) possono essere considerati caso per caso dopo consultazione con il Medico supervisore 10. Cardiopatia attiva, clinicamente significativa, incluso aritmia continua, al momento dello screening 11. Storia di angina instabile o infarto miocardico acuto nei tre mesi precedenti lo screening dello studio 12. Donne in gravidanza o in allattamento 13. Donne in età fertile con test di gravidanza positivo allo screening o alla baseline o che non utilizzano un metodo anticoncezionale accettabile. Metodi accettabili includono dispositivi intrauterini, o metodi meccanici (ad es., diaframma vaginale, spugna vaginale o preservativo con gel spermicida), astinenza sessuale o un partner che si è sottoposto a vasectomia. I contraccettivi orali non sono consentiti. Le donne possono essere chirurgicamente sterili o deve essere trascorso almeno 1 anno dall’ultimo ciclo mestruale 14. Storia di immunocompromissione, incluso un risultato positivo al test dell’HIV (ELISA e Western blot) 15. Essere stati sottoposti a chirurgia maggiore/terapia chirurgica per qualsiasi causa nelle 4 settimane prima della randomizzazione 16. Ipotiroidismo o ipocortisolismo non trattati adeguatamente con una dose stabile di terapia ormonale sostitutiva tiroidea o steroidea per ≥ 3 mesi 17. Storia di abuso di alcool o droga 18. Qualsiasi condizione che possa mettere a rischio la partecipazione allo studio (ad es., scoperte cliniche di screening o di laboratorio anomale clinicamente significative durante lo screening), l’interpretazione dei risultati dello studio o possa impedire la capacità di ottenere il consenso informato (ad es., condizione mentale) 19. Assunzione di un farmaco sperimentale entro 30 giorni prima dell’inclusione del paziente al presente studio 20. Terapia attuale o recente (&lt; 3 mesi) con pegvisomant 21. Terapia attuale o recente (&lt; 2 mesi) con cabergolina
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the IGF-1 concentration at the completion of the Treatment Period.
    L'endpoint primario di efficacia sono i livelli di IGF-1 a completamento del Periodo di trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment
    Fine del trattamento
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints is the GH concentration at the completion of the Treatment Period. The secondary safety endpoint is the safety and tolerability during the Treatment Period.-
    L'endpoint di efficacia è la concentrazione di GH a completamento del periodo di trattamento. L'endpoint secondario di sicurezza è la sicurezza e la tollerabilità durante il periodo di trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of treatment
    Fine del trattamento
    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 Yes
    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
    Conferma terapeutica (Fase III)
    Therapeutic confirmatory (Phase III)
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Terapia base
    Baseline Therapy
    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
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Brazil
    Canada
    Israel
    Mexico
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Database Lock
    Chiusura del Database
    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 months15
    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 months19
    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.1.2.1Number of subjects for this age range: 132
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 150
    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)
    Some subjects will be eligible for a long-term study extension, openlabel
    therapy. Some subjects will receive standard of care.
    Alcuni soggetti saranno eligibili per uno studio estensivo a lungo termine, terapia in aperto. Alcuni soggetti riceveranno la cura standard.
    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 Decision2011-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-05
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