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    Summary
    EudraCT Number:2021-000849-40
    Sponsor's Protocol Code Number:HS-19-657
    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:2021-10-19
    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 number2021-000849-40
    A.3Full title of the trial
    A randomized, multi-center, open-label, active-controlled Phase 3 trial to assess the efficacy and safety of octreotide subcutaneous depot (CAM2029) versus octreotide LAR or lanreotide ATG in patients with gastroenteropancreatic neuroendocrine tumors.
    Studio di Fase 3 randomizzato, multicentrico, in aperto, con controllo attivo per valutare l'efficacia e la sicurezza di octreotide depot sottocutaneo (CAM2029) rispetto a octreotide LAR o lanreotide ATG in pazienti con tumori neuroendocrini del tratto gastroenteropancreatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to assess efficacy and safety of octreotide subcutaneous depot in patients with GEP-NET
    Studio per valutare l'efficacia e la sicurezza di octreotide depot sottocutaneo in pazienti con GEPNET
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberHS-19-657
    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 organisationCamurus AB
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressIdeon Science Park
    B.5.3.2Town/ cityLund
    B.5.3.3Post codeSE-223 70
    B.5.3.4CountrySweden
    B.5.6E-mailregulatory@camurus.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 nameCAM2029 (Octreotide subcutaneous depot)
    D.3.2Product code [CAM2029]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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.3.9.2Current sponsor codeCAM2029
    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 RoleComparator
    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 Sandostatin LAR 30mg powder and solvent for suspension for injection
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceuticals UK Ltd
    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 nameocreotide acetate
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Powder and suspension 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 INNOCTREOTIDE ACETATE
    D.3.9.1CAS number 79517-01-4
    D.3.9.2Current sponsor codena
    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 number30
    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 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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Somatuline Autogel 120 mg, solution for injection in a prefilled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Ltd
    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 namelanreotide acetate
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNLANREOTIDE
    D.3.9.1CAS number 108736-35-2
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB08402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    gastroenteropancreatic neuroendocrine tumors
    tumori neuroendocrini del tratto gastroenteropancreatico
    E.1.1.1Medical condition in easily understood language
    gastroenteropancreatic neuroendocrine tumors
    tumori neuroendocrini del tratto gastroenteropancreatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10077559
    E.1.2Term Gastroenteropancreatic neuroendocrine tumour disease
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077560
    E.1.2Term Gastroenteropancreatic neuroendocrine tumor disease
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 superiority of treatment with CAM2029 compared to treatment with octreotide LAR or lanreotide ATG on PFS in patients with unresectable/metastatic and well-differentiated GEP-NET
    Valutare la superiorità del trattamento con CAM2029 rispetto al trattamento con octreotide a
    lento rilascio (LAR) o lanreotide autogel (ATG) sulla sopravvivenza libera da progressione (PFS) in pazienti con tumori neuroendocrini gastroenteropancreatici (GEP-NET) non resecabili/metastatici e ben differenziati
    E.2.2Secondary objectives of the trial
    • To assess superiority of treatment with CAM2029 compared to treatment with octreotide LAR or lanreotide ATG with respect to PFS based on local Investigator assessment
    • To compare the 2 treatment groups with respect to overall survival
    • To evaluate the 2 treatment groups with respect to ORR and DCR
    • To describe time to tumor response and duration of response in the 2 treatment groups
    • To evaluate the need for rescue medication for symptom control in the 2 treatment groups
    • To assess the PK of octreotide after CAM2029 administration
    • To assess octreotide exposure–response relationship for CAM2029
    • To assess supervised self- or partner-administration of CAM2029
    • To evaluate PROs for health-related quality of life in the 2 treatment groups
    • To evaluate the 2 treatment groups with respect to patient satisfaction with the treatment
    • To confirm the safety and tolerability of CAM2029 in patients with unresectable/metastatic and well-differentiated GEP-NET
    • Valutare la superiorità del trattamento con CAM2029 rispetto al trattamento con octreotide LAR o lanreotide ATG rispetto alla PFS in base alla valutazione dello sperimentatore locale
    • Confrontare i 2 gruppi di trattamento rispetto alla sopravvivenza complessiva
    • Valutare i 2 gruppi di trattamento rispetto all'ORR ed al DCR
    • Descrivere il tempo alla risposta del tumore e la durata della risposta nei 2 gruppi di trattamento
    • Valutare la necessità di un farmaco di salvataggio per il controllo dei sintomi nei 2 gruppi di trattamento
    • Valutare la PK di octreotide dopo la somministrazione di CAM2029
    • Valutare il rapporto esposizione-risposta di octreotide per CAM2029
    • Valutare l'auto-somministrazione o la somministrazione da parte del partner di CAM2029 supervisionata
    • Valutare gli esiti riferiti dai pazienti (PRO) relativamente alla qualità della vita correlata alla salute nei 2 gruppi di trattamento
    [...]
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patient =18 years old
    • Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin
    • At least 1 measurable, somatostatin receptor-positive*, lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization)
    *Somatostatin-receptor imaging must be performed within 3 months before randomization. Somatostatin receptor-positive lesions are defined as lesions with a visual assessment of uptake greater than the liver
    • Results from FDG-PET CT for patients with well-differentiated Grade 3 NET (if performed) must show that FDG avid areas of disease also are avid on somatostatin-receptor imaging
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
    • Paziente di sesso maschile o femminile di età =18 anni
    • NET istologicamente confermato, in stadio avanzato (non resecabile e/o metastatico) e ben differenziato di origine GEP o presunta origine GEP
    • Almeno 1 lesione misurabile positiva ai recettori della somatostatina* secondo i criteri RECIST 1.1 determinata mediante TC o RM multifasica (eseguita nei 28 giorni che precedono la randomizzazione)
    *L’imaging dei recettori della somatostatina deve essere eseguito nei 3 mesi precedenti la randomizzazione. Le lesioni positive ai recettori della somatostatina sono definite come lesioni con una valutazione visiva della captazione maggiore di quella del fegato
    • I risultati della TC FDG-PET per pazienti con NET di grado 3 ben differenziato (se eseguita) devono mostrare che le aree della malattia non refrattarie a FDG non sono refrattarie nemmeno all'imaging dei recettori della somatostatina
    • Stato prestazionale ECOG da 0 a 2
    E.4Principal exclusion criteria
    • Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease
    • Known central nervous system metastases
    • Consecutive treatment with long-acting SSAs for more than 6 months before randomization
    • Carcinoid symptoms that are refractory to treatment (according to the Investigator’s judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of =600 µg of octreotide IR
    • Previous treatment with more than 1 cycle (where 1 cycle means =28 days on treatment) of targeted therapies such as mTOR inhibitors (e.g. sirolimus, temsirolimus, or everolimus) or vascular endothelial growth factor inhibitors (e.g. sunitinib, lenvatinib, or cabozantinib), or more than 1 cycle of chemotherapy or interferon for GEP-NET
    • Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening
    • Previously received radioligand therapy (PRRT) at any time
    • Hepatic/pancreatic-related exclusion criteria:
    a) Active hepatitis. Patients with no significant viral load, no acute signs of inflammation, and no clinical necessity for therapy are allowed, at the Investigator’s discretion
    b) Symptomatic cholelithiasis
    c) Clinically active or chronic liver disease, including liver cirrhosis of Child-Pugh class B or C
    • Patients with poorly controlled diabetes, as evidenced by hemoglobin A1c (HbA1c) >8.0%
    • Cardiac history or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the trial, such as uncontrolled or significant cardiac disease, including any of the following:
    a )History of myocardial infarction, unstable angina pectoris, or coronary artery bypass graft within 6 months before screening
    b) Uncontrolled congestive heart failure
    • Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, or high-grade atrioventricular block (e.g. bifascicular block, Mobitz type II, and third-degree atrioventricular block)
    • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
    a) Risk factors for Torsades de Pointes, including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
    b) Treatment with concomitant medication(s) with a “known risk of Torsades de Pointes” per www.crediblemeds.org that cannot be discontinued or replaced with safe alternative medication at least 7 days or 5 half-lives (whichever is longer) before start of IMP treatment
    c) Patients with a baseline QTc interval corrected by Fridericia’s formula (QTcF) >450 msec for males and >470 msec for females at screening
    • Any other contraindicated serious medical condition that, in the Investigator’s opinion, may prevent the patient from safely participating in the trial
    • Evidenza documentata di progressione della malattia durante il trattamento (incluse SSA) per malattia localmente avanzata non resecabile o metastatica
    • Metastasi note al sistema nervoso centrale
    • Trattamento consecutivo con SSA ad azione prolungata per più di 6 mesi prima della randomizzazione
    • Sintomi carcinoidi refrattari al trattamento (secondo il giudizio dello sperimentatore) con dosi convenzionali di octreotide LAR o lanreotide ATG e/o al trattamento con dosi giornaliere di =600 µg di octreotide IR
    • Trattamento precedente con più di 1 ciclo (dove 1 ciclo significa =28 giorni di trattamento) di terapie mirate come inibitori del bersaglio della rapamicina nei mammiferi (mTOR) (ad es. sirolimus, temsirolimus o everolimus) o inibitori del fattore di crescita vascolare endoteliale (ad es. sunitinib, lenvatinib o cabozantinib) o più di 1 ciclo di chemioterapia o interferone per GEP-NET
    • Trattamento del GEP-NET con chemioembolizzazione transarteriosa o embolizzazione
    transarteriosa nei 12 mesi precedenti lo screening
    • Precedente terapia radioligante (terapia con radionuclidi del recettore peptidico) in qualsiasi momento
    • Criteri di esclusione epatici/pancreatici:
    ¿ Epatite attiva. Sono consentiti pazienti senza carica virale significativa, assenza di segni
    acuti di infiammazione e nessuna necessità clinica di terapia, a discrezione dello sperimentatore
    ¿ Colelitiasi sintomatica
    ¿ Epatopatia clinicamente attiva o cronica, inclusa la cirrosi epatica di classe B o C di Child- Pugh
    • Pazienti con diabete scarsamente controllato, come evidenziato dall'emoglobina A1c (HbA1c) >8,0%
    • Anamnesi cardiaca o diagnosi attuale di cardiopatia che indica un rischio significativo di sicurezza per i pazienti che partecipano alla sperimentazione, come una cardiopatia non controllata o significativa, tra cui le seguenti:
    ¿ Anamnesi di infarto miocardico, angina pectoris instabile o bypass aortocoronarico nei 6 mesi precedenti lo screening
    ¿ Insufficienza cardiaca congestizia non controllata
    • Aritmie cardiache clinicamente significative (ad es. tachicardia ventricolare), blocco di branca sinistra completo o blocco atrioventricolare di alto grado (ad es. blocco bifascicolare, Mobitz tipo II e blocco atrioventricolare di terzo grado)
    • Sindrome del QT lungo, anamnesi familiare di morte improvvisa idiopatica o sindrome congenita del QT lungo, o uno dei seguenti:
    ¿ Fattori di rischio per le torsioni di punta, tra cui ipokaliemia o ipomagnesiemia non
    corretta, anamnesi di insufficienza cardiaca o anamnesi di bradicardia clinicamente
    significativa/sintomatica
    ¿ Trattamento con farmaci concomitanti con un "rischio noto di torsione di punta" indicato da www.crediblemeds.org che non possono essere interrotti o sostituiti con un farmaco alternativo sicuro almeno 7 giorni o 5 emivite (a seconda di quale sia il periodo più lungo)
    prima dell'inizio del trattamento con l'IMP
    ¿ Pazienti con un intervallo QTc basale corretto dalla formula di Fridericia >450 msec per
    gli uomini e >470 msec per le donne allo screening
    • Qualsiasi altra condizione medica grave controindicata che, a giudizio dello sperimentatore, può impedire al paziente di partecipare in modo sicuro alla sperimentazione
    E.5 End points
    E.5.1Primary end point(s)
    PFS, defined as the time from the date of randomization to the date of the first documented disease progression as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first, as assessed by a Blinded Independent Review Committee (BIRC)
    PFS, definita come il tempo dalla data di randomizzazione alla data della prima progressione documentata della malattia secondo i criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST 1.1) o al decesso dovuto a qualsiasi causa, a seconda di quale evento si verifichi per primo, come valutato da un comitato di revisione indipendente in cieco (BIRC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause, whichever occurs first, as assessed by the BIRC
    alla data di randomizzazione alla data della prima progressione documentata della malattia secondo i criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST 1.1) o al decesso dovuto a qualsiasi causa, a seconda di quale evento si verifichi per primo, come valutato dal BIRC
    E.5.2Secondary end point(s)
    • PFS using RECIST 1.1 as assessed by local Investigators
    • Overall survival
    • ORR, defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) as per RECIST 1.1
    • DCR, defined as the proportion of patients with best overall response of CR, PR or stable disease (SD) as per RECIST 1.1
    • Time to response and duration of response as per RECIST 1.1
    • Average number of injections of octreotide rescue medication per month for each patient during the trial
    • Total dosage and dose intensity of rescue medication
    • Octreotide plasma concentrations over time
    • Correlation between octreotide concentration and other endpoints or measures as appropriate
    • Proportion of patients/partners declared competent by trial personnel to administer CAM2029 out of those trying
    • Change from baseline in Quality of Life Questionnaire – Neuroendocrine Carcinoid Module (QLQ-GINET21), Short Form-36 (SF-36), and the global health status/quality of life scale score of the European Organization for Research and Treatment of Cancer’s Core Quality of Life Questionnaire (EORTC QLQ-C30)
    • Treatment Satisfaction Questionnaire for Medication (TSQM) scores over time using all 4 domains of TSQM (effectiveness, side effects, convenience, and global satisfaction)
    • Adverse events (AEs) (including local tolerability)
    • Changes in laboratory values, vital signs, electrocardiogram readings and gallbladder imaging
    • PFS utilizzando i criteri RECIST 1.1 come valutato dagli sperimentatori locali
    • Sopravvivenza complessiva
    • ORR, definito come la percentuale di pazienti con la migliore risposta complessiva di risposta completa (CR) o risposta parziale (PR) secondo i criteri RECIST 1.1
    • DCR, definita come la percentuale di pazienti con la migliore risposta complessiva di CR, PR o malattia stabile (SD) secondo i criteri RECIST 1.1
    • Tempo alla risposta e durata della risposta secondo i criteri RECIST 1.1
    • Numero medio di iniezioni di farmaco di salvataggio octreotide al mese per ciascun paziente durante la sperimentazione
    • Dosaggio totale e intensità della dose del farmaco di salvataggio
    • Concentrazioni plasmatiche di octreotide nel tempo
    • Correlazione tra la concentrazione di octreotide e altri endpoint o misure come appropriato
    • Percentuale di pazienti/partner ritenuti competenti dal personale dello studio per somministrare CAM2029 tra coloro che provano a eseguire la somministrazione
    • Variazione dal basale nel Questionario sulla qualità della vita – Modulo sui tumori carcinoidi neuroendocrini (QLQ-GINET21), Short Form-36 (SF-36) e punteggio della scala globale sullo stato di salute/sulla qualità della vita del Questionario sulla qualità della vita Core dell'Organizzazione europea per la ricerca e il trattamento del cancro (EORTC QLQ-C30)
    • Punteggi del Questionario sulla soddisfazione del trattamento per i medicinali (TSQM) nel tempo utilizzando tutti e 4 i domini del TSQM (efficacia, effetti collaterali, convenienza e soddisfazione globale)
    • Eventi avversi (AE) (inclusa la tollerabilità locale)
    • Variazioni dei valori di laboratorio, dei parametri vitali, delle letture dell'elettrocardiogramma e dell'imaging della cistifellea
    E.5.2.1Timepoint(s) of evaluation of this end point
    Survival endpoints will be summarized by presenting the quartiles of the survival distribution and the survival rate at 12, 24, and 36 months in each treatment group, as well as the hazard ratio and 95% CI for the comparison between the treatment groups.

    For all efficacy endpoints, descriptive measures and 95% CI for the difference between the 2 treatment groups (CAM2029 and comparator) will be presented, unless otherwise specified.
    Gli endpoin di sopravvivenza saranno riassunti presentando i quartili della distribuzione della sopravvivenza ed il tasso di sopravvivenza a 12, 24 e 36 mesi in ciascun gruppo di trattamento nonché il rapporto di rischio e l'IC al 95% per il confronto tra i gruppi di trattamento.

    Per tutti gli endpoint di efficacia, verranno presentate misure descrittive e IC al 95% per la differenza tra i 2 gruppi di trattamento (CAM2029 e comparatore), se non diversamente specificato.
    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 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 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 No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    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
    Canada
    United States
    Belgium
    France
    Hungary
    Italy
    Netherlands
    Romania
    Spain
    United Kingdom
    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
    The overall end of trial is defined as the last protocol-specified contact with the last patient ongoing in the trial.
    La fine complessiva dello studio è definita dal protocollo come l'ultimo contatto con l'ultimo paziente ongoing nello studio.
    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
    E.8.9.2In all countries concerned by the trial years6
    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 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 302
    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)
    standard of care
    standard of care
    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 Decision2021-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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