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Estudio de AZD5305 como monoterapia y en combinación con agentes anticancerígenos en pacientes con neoplasias malignas sólidas avanzadas (PETRA)

18 de septiembre de 2026 actualizado por: AstraZeneca

Un estudio modular de fase I/IIa, abierto, multicéntrico para evaluar la seguridad, la tolerabilidad, la farmacocinética, la farmacodinámica y la eficacia preliminar de dosis ascendentes de AZD5305 como monoterapia y en combinación con agentes anticancerígenos en pacientes con neoplasias malignas sólidas avanzadas

This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

Descripción general del estudio

Descripción detallada

This study is a Phase I/IIa modular, open-label, multi-center study of AZD5305 administered orally, either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies.

Tipo de estudio

Intervencionista

Inscripción (Actual)

702

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Heidelberg, Australia, 3084
        • Research Site
      • Melbourne, Australia, 3000
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z 1K1
        • Research Site
    • Ontario
      • Toronto, Ontario, Canadá, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canadá, H3T 1E2
        • Research Site
      • Montreal, Quebec, Canadá, H2X 0A9
        • Research Site
      • Brno, Chequia, 656 53
        • Research Site
      • Prague, Chequia, 15006
        • Research Site
      • Seoul, Corea del Sur, 03080
        • Research Site
      • Seoul, Corea del Sur, 03722
        • Research Site
      • Seoul, Corea del Sur, 05505
        • Research Site
      • Seoul, Corea del Sur, 06351
        • Research Site
      • Barcelona, España, 08035
        • Research Site
      • Madrid, España, 28041
        • Research Site
      • Madrid, España, 28040
        • Research Site
      • Madrid, España, 28050
        • Research Site
      • Málaga, España, 29010
        • Research Site
      • Pozuelo de Alarcón, España, 28223
        • Research Site
      • Seville, España, 41013
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Research Site
      • Boston, Massachusetts, Estados Unidos, 02215
        • Research Site
    • New York
      • New York, New York, Estados Unidos, 10021
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Research Site
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Research Site
      • Budapest, Hungría, 1122
        • Research Site
      • Budapest, Hungría, 1062
        • Research Site
      • Budapest, Hungría, 1082
        • Research Site
      • Milan, Italia, 20141
        • Research Site
      • Milan, Italia, 20132
        • Research Site
      • Modena, Italia, 41125
        • Research Site
      • Naples, Italia, 80131
        • Research Site
      • Padova, Italia, 35128
        • Research Site
      • Roma, Italia, 00168
        • Research Site
      • Chūōku, Japón, 104-0045
        • Research Site
      • Kōtoku, Japón, 135-8550
        • Research Site
      • Bydgoszcz, Polonia, 85-796
        • Research Site
      • Gdansk, Polonia, 80-214
        • Research Site
      • Gdynia, Polonia, 81-519
        • Research Site
      • Grzepnica, Polonia, 72-003
        • Research Site
      • Lodz, Polonia, 90-302
        • Research Site
      • Torun, Polonia, 87-100
        • Research Site
      • Warsaw, Polonia, 02-781
        • Research Site
      • Beijing, Porcelana, 100142
        • Research Site
      • Changchun, Porcelana, 130021
        • Research Site
      • Changsha, Porcelana, 410013
        • Research Site
      • Chengdu, Porcelana, 610041
        • Research Site
      • Chongqing, Porcelana, 400030
        • Research Site
      • Guangzhou, Porcelana, 510060
        • Research Site
      • Harbin, Porcelana, 150081
        • Research Site
      • Jining, Porcelana, 272029
        • Research Site
      • Shandong, Porcelana
        • Research Site
      • Shanghai, Porcelana, 200032
        • Research Site
      • Shanghai, Porcelana, 200025
        • Research Site
      • Taiyuan, Porcelana, 030001
        • Research Site
      • Wuhan, Porcelana, 430079
        • Research Site
      • Xi'an, Porcelana, 710061
        • Research Site
      • Cambridge, Reino Unido, CB2 0QQ
        • Research Site
      • Manchester, Reino Unido, M20 4BX
        • Research Site
      • Oxford, Reino Unido, OX3 7LE
        • Research Site
      • Sutton, Reino Unido, SM2 5PT
        • Research Site
      • Moscow, Rusia, 115478
        • Research Site
      • Moscow, Rusia, 117997
        • Research Site
      • Moscow, Rusia, 111123
        • Research Site
      • Moscow, Rusia, 143442
        • Research Site
      • Chernivtsі, Ucrania, 58013
        • Research Site
      • Ivano-Frankivsk, Ucrania, 76018
        • Research Site
      • Kyiv, Ucrania, 03022
        • Research Site
      • Uzhhorod, Ucrania, 88000
        • Research Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 130 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Key Inclusion Criteria:

  • Age ≥ 18 at the time of screening
  • Histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria..
  • Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)
  • Life expectancy ≥ 12 weeks
  • Progressive cancer at the time of study entry
  • Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B
  • Adequate organ and marrow function as defined by the protocol.
  • For Part B expansion cohorts: Provision of formalin-fixed and paraffin embedded (FFPE) tumour specimen is mandatory, where available, except if stated that it is optional in a specific Module.

For Part A:

- Patients may have received up to one prior line of therapy with a PARPi-based regimen (either as a treatment or as maintenance)

For Part B:

- Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).

Key Exclusion Criteria:

  • Treatment with any of the following:

    1. Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
    2. Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 3 weeks (whichever is shorter) of the first dose of study treatment
    3. Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
    4. Any live virus or bacterial vaccine within 28 days of the first dose of study treatment
  • Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong inhibitors or inducers.

  • Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.

  • Receiving continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent for any reason.

  • Major surgery within 4 weeks of the first dose of study treatment.

  • Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.

  • Any history of persisting (> 2 weeks) severe pancytopenia due to any cause

  • Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of >10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.

  • patient with known predisposition to bleeding (e.g., active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).

  • Cardiac conditions as defined by the clinical study protocol

  • Other cardiovascular diseases as defined by any of the following:

    1. Symptomatic heart failure,
    2. uncontrolled hypertension,
    3. hypertensive heart disease with significant left ventricular hypertrophy
    4. acute coronary syndrome (ACS)/acute myocardial infarction (AMI), unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months.
    5. cardiomyopathy of any etiology
    6. presence of clinically significant valvular heart disease
    7. history of atrial or ventricular arrhythmia requiring treatment; subjects with atrial fibrillation and optimally controlled ventricular rate (< 100 beats per minute) are permitted.
    8. subjects with atrial fibrillation and optimally controlled ventricular rate are permitted
    9. transient ischaemic attack, or stroke within 6 months prior to screening
    10. patients with symptomatic hypotension at screening
  • Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).

  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305

  • Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).

Prior malignancy whose natural history, in the Investigator's opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.

other module-specific criteria may apply

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Module 1: AZD5305 Monotherapy

AZD5305 Monotherapy

Oral PARP inhibitor

Experimental: Module 2: AZD5305 + Paclitaxel

AZD5305 + Paclitaxel

Oral PARP inhibitor

IV Anti-microtubule agent

Experimental: Module 3: AZD5305 + Carboplatin with or without Paclitaxel

AZD5305 + Carboplatin with or without Paclitaxel

Oral PARP inhibitor

IV Anti-microtubule agent

IV Platinum chemotherapeutic

Experimental: Module 4: AZD5305 + Trastuzumab Deruxtecan

AZD5305 + T- DXd

Oral PARP inhibitor

IV Antibody-drug conjugate

Experimental: Module 5 AZD5305 + Datopotamab Deruxtecan

AZD5305 + Dato-DXd

Oral PARP inhibitor

IV Antibody-drug conjugate

Experimental: Module 6 AZD5305 + Camizestrant

AZD5305 + Camizestrant

Oral PARP inhibitor

Oral SERD Molecule

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The number of subjects with adverse events/serious adverse events
Periodo de tiempo: From time of Informed Consent to 28 + 7 days post last dose ( modules 1,2,3,5 and 6). 40+7 days post last dose for Module 4.

Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline

From time of Informed Consent to 28 + 7 days post last dose ( modules 1,2,3,5 and 6). 40+7 days post last dose for Module 4.
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.
Periodo de tiempo: From first dose of study treatment until the end of Cycle 1.

A DLT is defined as any toxicity that occurs from the first dose of study treatment (either AZD5305 or combination anti-cancer agent) up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation. DLTs occurring outside the DLT window (ie, late onset toxicities) may be defined as a DLT after consultation with the sponsor and investigators, based on the emerging safety profile.

From first dose of study treatment until the end of Cycle 1.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Best percentage change in target lesion
Periodo de tiempo: From Screening to confirmed progressive disease (approximately 1 year)

Change in target lesion size from baseline, as defined by RECIST 1.1.

From Screening to confirmed progressive disease (approximately 1 year)
Objective Response Rate
Periodo de tiempo: From Screening to confirmed progressive disease (approximately 1 year)

Best response until progression, as defined by RECIST 1.1.

From Screening to confirmed progressive disease (approximately 1 year)
Duration of Response
Periodo de tiempo: From Screening to confirmed progressive disease (approximately 1 year)

Time from first response to progression or death , as defined by RECIST 1.1.

From Screening to confirmed progressive disease (approximately 1 year)
Progression Free Survival
Periodo de tiempo: From Screening to confirmed progressive disease (approximately 1 year)

Time from C1D1 to progression or death, as defined by RECIST 1.1.

From Screening to confirmed progressive disease (approximately 1 year)
Time To Response
Periodo de tiempo: From Screening to confirmed progressive disease (approximately 1 year)

Time from C1D1 to complete or partial response, as defined by RECIST 1.1.

From Screening to confirmed progressive disease (approximately 1 year)
Effects of AZD5305 on pH2AX (Ser139) PD biomarker
Periodo de tiempo: From Cycle 0 Day 1 to Cycle 1 Day 15 (approximately 21 days)

Measure change from baseline in pH2AX

From Cycle 0 Day 1 to Cycle 1 Day 15 (approximately 21 days)
CA125 response (ovarian cancer)
Periodo de tiempo: From Screening to confirmed progressive disease (approximately 1 year)

at least a 50% reduction in CA125 levels from a pre-treatment sample as defined by GCIG criteria.

From Screening to confirmed progressive disease (approximately 1 year)
Module 1: Area Under Curve (AUC)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 1: Maximum plasma concentration of the drug (Cmax)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 1: The time taken to reach the maximum concentration (Tmax)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 1 and Module 5: Objective Response Rate (prostate cancer)
Periodo de tiempo: From Screening to confirmed progressive disease (approximately 1 year)

Best response until progression, as defined by RECIST 1.1 or PCWG3 (bone)

From Screening to confirmed progressive disease (approximately 1 year)
Module 1: Radiographic progression free survival (prostate cancer)
Periodo de tiempo: From Screening to confirmed progressive disease (approximately 1 year)

Time from C1D1 to progression or death, as defined by RECIST 1.1 and PCWG3(bone).

From Screening to confirmed progressive disease (approximately 1 year)
Module 1: Proportion of subjects with ≥ 50% PSA decrease (prostate cancer)
Periodo de tiempo: From Screening to confirmed progressive disease (approximately 1 year)

PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment

From Screening to confirmed progressive disease (approximately 1 year)
Module 1 : To investigate the effect of a high-fat meal on the PK of AZD5305
Periodo de tiempo: Cycle 0, Day 1 (C0D1), in either the "fasted" or "fed" state, followed by a single oral dose of AZD5305 in the other state for Cycle 1, Day 1 (C1D1) at least 72 hours later; 1 cycle is 28 days.

Effect on High fat meal on PK parameters of AZD5305.PK parameters, including but not limited to AUC and/or AUC(0-t), Cmax, Tmax, AUC(0-t) and Cmax ratio, with and without food

Cycle 0, Day 1 (C0D1), in either the "fasted" or "fed" state, followed by a single oral dose of AZD5305 in the other state for Cycle 1, Day 1 (C1D1) at least 72 hours later; 1 cycle is 28 days.
Module 2: Area Under Curve (AUC)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 2: Maximum plasma concentration of the drug (Cmax)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 2: The time taken to reach the maximum concentration (Tmax)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 3: Area Under Curve (AUC)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 3: Maximum plasma concentration of the drug (Cmax)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 3: The time taken to reach the maximum concentration (Tmax)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 4 : Area Under Curve
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 4: Maximum plasma concentration of the drug (Cmax)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 4: The time taken to reach the maximum concentration (Tmax)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 4: Anti-Drug Antibody (ADA)
Periodo de tiempo: Samples will be collected within 1 hour before dose administration on Day 1 of Cycle 1, 2, and 4, then every 4 Cycles (each cycle is 21 days), EoT, and at safety follow-up (40 days after last dose) as per Schedule of Assessments

To investigate the presence of ADAs for T-DXd

Samples will be collected within 1 hour before dose administration on Day 1 of Cycle 1, 2, and 4, then every 4 Cycles (each cycle is 21 days), EoT, and at safety follow-up (40 days after last dose) as per Schedule of Assessments
Module 4: To assess the preliminary anti-tumour activity of AZD5305 as monotherapy and in combination with T-DXd.
Periodo de tiempo: From screening to approximately 6 months

Time from C1D1 to progression or death, as defined by RECIST v 1.1 summarised at the 6 month landmark (PFS6)

From screening to approximately 6 months
Module 5: Area Under Curve
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 5: Maximum plasma concentration of the drug (Cmax)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 5: The time taken to reach the maximum concentration (Tmax)
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 5: Anti-Drug Antibody (ADA)
Periodo de tiempo: Whole blood samples for determination of ADA for Dato-DXd in plasma will be collected in patients receiving Dato-DXd per the schedule specified in the SoA : Day 1 of Cycle 1, 2, 4, and 8 (each cycle is 21 days) , EoT, and then 28 day follow up visit.

Presence of ADAs for Dato-DXd

Whole blood samples for determination of ADA for Dato-DXd in plasma will be collected in patients receiving Dato-DXd per the schedule specified in the SoA : Day 1 of Cycle 1, 2, 4, and 8 (each cycle is 21 days) , EoT, and then 28 day follow up visit.
Module 5: Premilinary anti tumour activity AZD5305 in combination with Dato-DXd
Periodo de tiempo: From screening to confirmed progresive disease ( approximately 12 weeks)

objective response rate and radiographic progression-free survival using RECIST v1.1.

Proportion of patients achieving a ≥ 50% decrease in PSA from baseline to the post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later (PSA50 response).

From screening to confirmed progresive disease ( approximately 12 weeks)
Module 6: To characterise the PK of AZD5305 and camizestrant following a single dose and at steady state after multiple dosing, when given in combination.
Periodo de tiempo: At predefined interval throughout the treatment (approximately 12 weeks)

Plasma concentrations and PK parameters of AZD5305 and camizestrant after single dose and multiple dose administration, including, but not limited to:

AUC, Cmax, Tmax, as data allow

At predefined interval throughout the treatment (approximately 12 weeks)
Module 6: To evaluate the effect of camizestrant on the PK of AZD5305.
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

PK parameters, including but not limited to AUC and/or AUC(0-t), Cmax, Tmax, AUC(0-t) and Cmax ratio, with and without camizestrant.

At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 6: To evaluate the effect of AZD5305 on the PK of Camizestrant.
Periodo de tiempo: At predefined intervals throughout the treatment period (approximately 12 weeks)

PK parameters, including but not limited to AUC and/or AUC(0-t), Cmax, Tmax, AUC(0-t) and Cmax ratio, with and without AZD5305.

At predefined intervals throughout the treatment period (approximately 12 weeks)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Timothy Yap, M.D. Anderson Cancer Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de noviembre de 2020

Finalización primaria (Estimado)

28 de mayo de 2027

Finalización del estudio (Estimado)

28 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

26 de octubre de 2020

Primero enviado que cumplió con los criterios de control de calidad

19 de noviembre de 2020

Publicado por primera vez (Actual)

25 de noviembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D9720C00001
  • 2020-002688-77 (Número EudraCT)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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