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    Summary
    EudraCT Number:2019-002190-66
    Sponsor's Protocol Code Number:HS-19-647
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-13
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-002190-66
    A.3Full title of the trial
    A Phase 3, open-label, single-arm, multi-center trial to assess the long term safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly
    Studio multicentrico, in aperto, a braccio singolo, di fase III con lo scopo di valutare la sicurezza a lungo termine del deposito sottocutaneo di octreotide (CAM2029) in pazienti affetti da acromegalia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to assess the long-term safety of octreotide subcutaneous depot in patients with acromegaly
    Una sperimentazione per valutare la sicurezza a lungo termine del deposito sottocutaneo di octreotide in pazienti con acromegalia
    A.3.2Name or abbreviated title of the trial where available
    A Phase 3 trial to assess the long term safety of octreotide subcutaneous depot in patients with acr
    Studio di fase III con lo scopo di valutare la sicurezza a lungo termine del deposito sottocutaneo d
    A.4.1Sponsor's protocol code numberHS-19-647
    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 SponsorCamurus AB
    B.1.3.4CountrySweden
    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 supportCamurus AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccelsiors CRO and Consultancy Services Ltd
    B.5.2Functional name of contact pointregulatory unit
    B.5.3 Address:
    B.5.3.1Street Address103 Haros Str
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1222
    B.5.3.4CountryHungary
    B.5.4Telephone number+3612990091
    B.5.5Fax number+3612990096
    B.5.6E-mailregulatory@accelsiors.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/645
    D.3 Description of the IMP
    D.3.1Product nameCAM2029 (Octreotide subcutaneous depot)
    D.3.2Product code [CAM2029]
    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 INNoctreotide
    D.3.9.1CAS number 83150-76-9
    D.3.9.2Current sponsor codeCAM2029
    D.3.9.4EV Substance CodeSUB192677
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/645
    D.3 Description of the IMP
    D.3.1Product nameCAM2029 (Octreotide subcutaneous depot)
    D.3.2Product code [CAM2029]
    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 INNoctreotide
    D.3.9.1CAS number 83150-76-9
    D.3.9.2Current sponsor codeCAM2029
    D.3.9.4EV Substance CodeSUB192677
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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.
    L'acromegalia è un disordine metabolico cronico in cui c'è troppo ormone della crescita e i tessuti del corpo si allargano gradualmente.
    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 10000599
    E.1.2Term Acromegaly
    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 assess the overall safety and tolerability of CAM2029
    • Valutare la sicurezza e la tollerabilità complessiva di CAM2029
    E.2.2Secondary objectives of the trial
    To assess efficacy of CAM2029 based on biochemical characteristics.
    To assess self-and partner administration
    To assess plasma concentration of octreotide after administration of CAM2029
    • Valutare l’efficacia di CAM2029 nella risposta biochimica
    • Valutare la somministrazione controllata di CAM2029 eseguita dal partner o autonomamente
    • Valutare le concentrazioni plasmatiche di octreotide dopo la somministrazione di CAM2029 nei pazienti con acromegalia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patients =18 years at screening
    Able to provide written informed consent to participate in the trial
    Diagnosis of acromegaly by historical evidence (persistent or recurrent) acromegaly
    Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
    IGF-1 levels >1xULN and =1.3xULN at screening or IGF-1 levels <=1xULN at screnning with prior pituitary radiotherapy
    Adequate liver, pancreatic, renal and bone marrow f unctions
    Normal ECG
    - Pazienti maschi o femmine, =18 anni allo screening
    - In grado di fornire il consenso informato scritto per partecipare alla sperimentazione prima di eseguire qualsiasi procedura relativa alla sperimentazione
    - Diagnosi di acromegalia mediante evidenze anamnestiche di acromegalia (persistente o ricorrente)
    - Trattamento con una dose stabile di octreotide LAR o lanreotide ATG per almeno 3 mesi come monoterapia prima dello screening
    - Livelli di IGF-1 >1 x ULN e = 1,3 x ULN allo screening oppure livelli di IGF-1 = 1 x ULN allo screening, con una precedente radioterapia ipofisaria
    - Adeguata funzionalità epatica, pancreatica, renale e del midollo osseo
    - ECG normale
    E.4Principal exclusion criteria
    For Roll-over Patients from Trial HS-18-633:
    • Unresolved, drug-related serious adverse event (SAE) from the preceding trial (HS-18-633)
    • Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation
    For New Patients:
    • Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer])
    • Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
    • Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated
    • Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening
    • Patients who have undergone pituitary surgery within 6 months prior to screening
    • Patients who have received prior pituitary irradiation within 3 years prior to screening
    • Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)
    Per i pazienti di roll-over dagli studi HS-18-633
    • Eventi avversi gravi (SAE) correlati al farmaco non risolti dallo studio precedente (HS-18-633)
    • Pazienti con una condizione medica o chirurgica clinicamente significativa o instabile che possa precludere la partecipazione sicura e completa allo studio
    Per i nuovi pazienti
    • Avere ricevuto un trattamento medico per l’acromegalia con pasireotide (entro 6 prima dallo screening), pegvisomant (entro 3 mesi prima dello screening), agonisti della dopamina (entro 3 mesi prima dello screening) o altri agenti sperimentali (entro 30 giorni o 5 emivite prima dello screening [a seconda di qual è il più lungo])
    • Pazienti che abitualmente assumono LAR o lanreotide ATG con frequenza inferiore a una volta ogni 4 settimane (ad es. ogni 6 o 8 settimane)
    • Pazienti con compressione del chiasma ottico che causa un difetto del campo visivo per il quale sia indicato un intervento chirurgico
    • Pazienti sottoposti a terapia chirurgica/intervento chirurgico importante per qualsivoglia causa, entro 1 mese dallo screening
    • Pazienti che si siano sottoposti a intervento chirurgico del tumore ipofisario entro 6 mesi prima dello screening
    • Pazienti che abbiano ricevuto pregressa radioterapia ipofisaria nei 3 anni precedenti allo screening
    • Pazienti con diabete mellito scarsamente controllato (emoglobina A1c > 8,0%)
    E.5 End points
    E.5.1Primary end point(s)
    • Characterization of adverse events (AEs)
    • Caratterizzazione degli eventi avversi (AE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    Settimana 52
    E.5.2Secondary end point(s)
    • Proportion of patients with mean IGF-1 levels =1 x upper limit of
    normal (ULN) and =1.3xULN at Week 50 and Week 52
    • Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L at Week 50 and Week 52
    - Proportion of patients/partners declared competent by healthcare professional to administer CAM2029
    - Octreotide plasma concentrations over time
    • Percentuale di pazienti con livelli medi di IGF-1 = 1,3 x ULN alla Settimana 50 e alla Settimana 52
    • Percentuale di pazienti con livelli medi di GH < 2,5 µg/l alla Settimana 50 e alla Settimana 52
    • Percentuale di pazienti/partner dichiarati competenti da un professionista sanitario per quanto concerne la somministrazione di CAM2029
    • Concentrazioni plasmatiche di octreotide nel tempo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 50 and Week 52
    Settimana 50 e alla Settimana 52
    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 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 No
    E.8.1.2Open No
    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 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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    Turkey
    United States
    Bulgaria
    Germany
    Greece
    Hungary
    Italy
    Poland
    Spain
    Sweden
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 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: 124
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 140
    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)
    Patients will be switched back to standard treatment for acromegaly.
    I pazienti torneranno al trattamento standard per l'acromegalia.
    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 Decision2020-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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