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    Summary
    EudraCT Number:2021-000849-40
    Sponsor's Protocol Code Number:HS-19-657
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-08
    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 ConcernedSpain - AEMPS
    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.
    Ensayo en fase 3 aleatorizado, multicéntrico, abierto, comparativo con tratamiento activo para evaluar la eficacia y seguridad de octreotida (CAM2029) subcutánea de liberación prolongada frente a octreotida LP o lanreotida ATG en pacientes con tumores neuroendocrinos gastroenteropancreáticos
    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
    Ensayo para evaluar la eficacia y seguridad de octreotida subcutánea de liberación prolongada en pacientes con TNE-GEP
    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 Prolonged-release 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.3.9.2Current sponsor codeCAM2029
    D.3.9.3Other descriptive nameOCTREOTIDE HYDROCHLORIDE
    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 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 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.2.5The 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 nameOctreotide acetate
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOCTREOTIDE ACETATE
    D.3.9.1CAS number 79517-01-4
    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 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 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.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.2.5The 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.3.4Pharmaceutical 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.3.9.3Other descriptive nameLANREOTIDE
    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 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 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
    tumores neuroendocrinos gastroenteropancreáticos
    E.1.1.1Medical condition in easily understood language
    gastroenteropancreatic neuroendocrine tumors
    tumores neuroendocrinos gastroenteropancreáticos
    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 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.1.2 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.1.3Condition 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
    Evaluar la superioridad del tratamiento con CAM2029 en comparación con el tratamiento con octreotida de liberación prolongada (LP) o lanreotida autogel (ATG) con respecto a la supervivencia sin progresión (SSP) en pacientes con tumores neuroendocrinos gastroenteropancreáticos (TNE-GEP) irresecables/metastásicos y bien diferenciados
    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
    -Evaluar la superioridad del tratamiento con CAM2029 en comparación con el tratamiento con octreotida LP o lanreotida ATG con respecto a la SSP en función de la valoración del investigador local
    -Comparar 2 grupos de tratamiento con respecto a la SG
    -Evaluar los 2 grupos de tratamiento con respecto a (TRG) y (TCE)
    -Describir el t. transcurrido hasta la respuesta al tumor y la duración de la respuesta en 2 grupos de trata.
    -Evaluar un medicamento de rescate para la supresión de los síntomas en los 2 grupos de tratamiento
    -Evaluar la FC de la octreotida tras la administración de CAM2029
    -Evaluar la relación expos-resp de la octre. para CAM2029
    -Evaluar la administración por la pareja supervisadas de CAM2029
    -Evaluar (RCP) para la calidad de vida relacionada con la salud en los 2 grupos de tratamiento
    -Evaluar los 2 grupos de tratamiento con respecto a la satisfacción del paciente con el tratamiento
    -Confirmar la seguridad y la tolerabilidad de CAM2029 en pacientes con TNE-GEP
    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
    -Paciente hombre o mujer ≥ 18 años
    -TNE confirmado histológicamente, avanzado (irresecable y/o metastásico) y bien diferenciado de origen GEP o de supuesto origen GEP
    -Al menos 1 lesión mensurable según RECIST 1.1 que haya sido determinada por RM o TAC multifásico (realizado en los 28 días anteriores a la aleatorización)
    *Receptores de la somatostatina en lesiones documentadas con TAC o RM, evaluados con modalidades de imágenes de los receptores de la somatostatina en los 3 meses anteriores a la aleatorización
    -Los resultados de TAC o de TEP-FDG para pacientes con TNE de grado 3 bien diferenciado (si se han realizado) deben mostrar que las zonas afines de la FDG también son afines en las imágenes de los receptores de la somatostatina
    -Estado funcional de 0 o 2 del Grupo Colaborador de Oncología del Este
    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
    -Prueba documentada de progresión de la enfermedad durante el tratamiento (incluidos los ASS) para enfermedad metastásica o irresecable de avance localizado
    -Metástasis conocidas en el sistema nervioso central
    -Tratamiento consecutivo con ASS de acción prolongada durante más de 6 meses antes de la aleatorización
    -Síntomas carcinoides resistentes al tratamiento (de acuerdo con el criterio del investigador) con dosis convencionales de octreotida LP o lanreotida ATG y/o al tratamiento con dosis diarias de ≤ 600 μg de octreotida LI
    -Tratamiento anterior con más de 1 ciclo (donde 1 ciclo significa ≤ 28 días de tratamiento) de terapias dirigidas, como los inhibidores del mTOR (p. ej. sirólimus, temsirólimus o everólimus) o los inhibidores de los factores de crecimiento del endotelio vascular (p. ej. sunitinib, lenvatinib o cabozantinib), o más de 1 ciclo de quimioterapia o interferón para TNE-GEP
    -Tratamiento de TNE-GEP con quimioembolización transarterial o embolización transarterial en los 12 meses anteriores a la selección
    -Tratamiento con radioligandos recibido en cualquier momento
    -Criterios de exclusión relacionados con el hígado y el páncreas:
    a)Hepatitis activa. Son aptos, a criterio del investigador, los pacientes sin carga viral significativa, sin signos agudos de inflamación y sin necesidad clínica de terapia
    b)Colelitiasis sintomática
    c)Enfermedad hepática crónica o clínicamente activa, incluida la cirrosis hepática de clase B o C según el índice Child-Pugh
    -Pacientes con diabetes débilmente controlada, según prueba de hemoglobina A1c (HbA1c) > 8,0 %
    -Antecedentes cardiacos o diagnóstico actual de cardiopatía que indique un riesgo significativo para la seguridad de los pacientes que participan en el ensayo, como cardiopatía significativa o no controlada, incluido cualquiera de los puntos siguientes:
    a)Antecedentes de infarto de miocardio, angina de pecho inestable o injertos en arteria coronaria en los 6 meses anteriores a la selección
    b)Insuficiencia cardiaca congestiva no controlada
    -Arritmias cardiacas clínicamente significativas (p. ej. taquicardia ventricular), bloqueo completo de rama izquierda o bloqueo auriculoventricular de alto grado (p. ej. bloqueo bifascicular, bloqueo auriculoventricular Mobitz tipo II y de tercer grado)
    -Síndrome de QT largo, antecedentes familiares de muerte súbita de origen idiopático o síndrome de QT largo congénito, o cualquiera de los siguientes puntos:
    a)Factores de riesgo de Torsades de Pointes, que incluyen hipopotasemia no corregida o hipomagnesemia, antecedentes de insuficiencia cardiaca o de bradicardia sintomática/clínicamente significativa
    b)Tratamiento con medicamentos simultáneos con un “riesgo conocido de Torsades de Pointes” según el sitio www.crediblemeds.org que no se pueden interrumpir ni sustituir por una alternativa segura al menos 7 días o 5 semividas (lo que dure más) antes de iniciar el tratamiento con el MEI
    c)Pacientes con un intervalo QTc inicial corregido según la fórmula de Fridericia (QTcF) > 450 ms para hombres y > 470 ms para mujeres en la selección
    -Cualquier otra enfermedad grave contraindicada que, en opinión del investigador, pudiera impedir al paciente participar de manera segura en el ensayo
    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)
    SSP, que se define como el tiempo desde la fecha de aleatoriazación hasta la fecha de la primera progresión de la enfermedad documentada según los criterios de evaluación de la respuesta en tumores sólidos, versión 1.1 (RECIST 1.1) o el resultado de muerte por cualquier causa, lo que ocurra primero, conforme a evaluación de un comité de revisión independiente desconocedor del tratamiento (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
    Tiempo desde la fecha de aleatoriazación hasta la fecha de la progresión documentada según RECIST 1.1 o el resultado de muerte por cualquier causa, lo que ocurra primero
    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
    -SSP según RECIST 1.1 conforme a evaluación de los investigadores locales
    -Supervivencia global
    -TRG, que se define como la proporción de pacientes con la mejor respuesta global de remisión completa (RC) o remisión parcial (RP) según RECIST 1.1
    -TCE, que se define como la proporción de pacientes con la mejor respuesta global de RC, RP o enfermedad estable (EE) según RECIST 1.1
    -Tiempo transcurrido hasta la respuesta y duración de la respuesta según RECIST 1.1
    -Promedio de inyecciones del medicamento de rescate de la octreotida al mes por cada paciente durante el ensayo
    -Dosis total e intensidad de la dosis del medicamento de rescate
    -Concentraciones de octreotida en plasma a lo largo del tiempo
    -Correlación entre la concentración de octreotida y otros criterios de valoración o medidas, según corresponda
    -Proporción entre pacientes/parejas declarados competentes por el personal del ensayo para administrar CAM2029 y aquellos que lo intentan
    -Cambios en los valores iniciales del cuestionario sobre calidad de vida – módulo sobre carcinoide neuroendocrino (QLQ-GINET21), el formulario breve 36 (SF-36) y las puntuaciones en la escala de calidad de vida/estado de salud global del cuestionario principal sobre calidad de vida de la Organización Europea de Investigación y Tratamiento del Cáncer (EORTC QLQ-C30)
    -Puntuaciones a lo largo del tiempo en el cuestionario sobre satisfacción del paciente con el medicamento de un tratamiento (TSQM) con las 4 dimensiones del TSQM (eficacia, efectos secundarios, conveniencia y satisfacción global)
    -Acontecimientos adversos (AA) (incluida la tolerabilidad local)
    -Cambios en valores de análisis, constantes vitales, lecturas de electrocardiograma e imágenes de la vesícula biliar
    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.
    Las variables de supervivencia se resumirán presentando los cuartiles de la distribución de supervivencia y la tasa de supervivencia a los 12, 24 y 36 meses en cada grupo de tratamiento, así como la relación de riesgo y el IC del 95% para la comparación entre los grupos de tratamiento.

    Para todas las variables de eficacia, se presentarán medidas descriptivas y IC del 95% para la diferencia entre los 2 grupos de tratamiento (CAM2029 y comparador), a menos que se especifique lo contrario.
    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 concerned9
    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 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
    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.
    El final del ensayo se define como el último contacto especificado en el protocolo como último paciente en curso en el ensayo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months9
    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 state45
    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
    Estandar de tratamiento
    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 Decision2021-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-06
    P. End of Trial
    P.End of Trial StatusOngoing
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