ROSY-D: Estudio de Incorporación (Roll Over StudY) para Pacientes que Han Completado un Estudio Oncológico Previo con Durvalumab y que el Investigador Considera que se Benefician Clínicamente del Tratamiento Continuo

Por invitaciónFase 3ClinicalTrials.gov

ID: NCT05303532Tipo: INTERVENTIONALInicio: 19 de abr de 2022Fin estimado: 31 de dic de 2026

Resumen

El fundamento del estudio ROSY-D es continuar proporcionando el tratamiento del estudio a pacientes que han participado en un estudio original con durvalumab y que siguen obteniendo beneficio clínico del tratamiento al finalizar dichos estudios, según el criterio del Investigador.

Descripción detallada

ROSY-D es un ensayo abierto, no aleatorizado, multicéntrico e internacional para pacientes que han completado un estudio original con durvalumab y que, según el criterio del Investigador, siguen obteniendo beneficio clínico del tratamiento continuo. Los pacientes serán incorporados desde el estudio original y continuarán el estudio indefinidamente, hasta que cumplan alguno de los criterios de discontinuación del tratamiento.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

Provision of signed and dated, written Informed Consent Form (ICF).
Patient is currently deriving clinical benefit, as judged by the investigator, from continued treatment in an AstraZeneca parent study using an AstraZeneca compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent study's protocol.
Patient can receive durvalumab as a fixed dose of 1500 mg quarterly 4 weeks at study entry.

Criterios de exclusión

Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
Currently receiving treatment with any prohibited medication(s).
Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Permanent discontinuation from the parent study due to toxicity or disease progression (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological \[example: Response Evaluation Criteria in Solid Tumours\] progression or clinical progression).
Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation.
Active infection including Coronavirus disease 2019 (Polymerase chain reaction confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive Hepatitis B virus (HBV) surface antigen result), hepatitis C, or Human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies).
Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy.
Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of ≤ 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.

Intervenciones

drug

Durvalumab

Fixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter.

Ubicaciones

Research Site

Rosario, Argentina

Patrocinadores

PrincipalAstraZeneca

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

ROSY-D: Estudio de Incorporación (Roll Over StudY) para P... | EligiMed