An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who Are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE)

CompletadoFase 4ClinicalTrials.gov

ID: NCT04078152Tipo: INTERVENTIONALInicio: 5 de sept de 2019Fin estimado: 31 de oct de 2024

Traducción no disponible, mostrando original

Resumen

The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.

Descripción detallada

This is a multicenter, open-label, global study that will enroll patients who are currently receiving durvalumab monotherapy, or have previously received durvalumab as monotherapy or in combination with any other approved or investigational anticancer agents, in an eligible AstraZeneca/MedImmune-sponsored clinical study.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

Patient must be 18 years or older, at the time of signing the ICF. For subjects aged \< 20 years and enrolled in Japan, a written ICF should be obtained from the subject and his or her legally acceptable representative.
Patient received durvalumab monotherapy and/or durvalumab containing combination in an AstraZeneca/MedImmune-sponsored parent clinical study that is approved for enrollment into this study.
Patients who received durvalumab in combination with any other approved or investigational anticancer agents in the parent clinical study must have completed or discontinued all other anticancer therapy (beyond durvalumab regimen).
Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures.

Criterios de exclusión

Currently receiving treatment in another interventional study other than the parent clinical study or, for retreatment patients, received treatment during the follow up period with an agent other than durvalumab
Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment
Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study
Diagnosis of a new primary malignancy since enrollment into the parent clinical study

Intervenciones

drug

Durvalumab

IV infusion q4w with 1500mg durvalumab until progressive disease

Ubicaciones

Research Site

Rosario, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorIqvia Pty Ltd

ColaboradorParexel

ColaboradorMedidata Solutions

ColaboradorCISCRP

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.

An Open-Label, Multi-Center, Global Study to Evaluate Lon... | EligiMed