Brightline-4: Estudio de fase III, abierto, de brazo único, multicéntrico, para evaluar la seguridad y eficacia del tratamiento con brigimadlin (BI 907828) en pacientes con liposarcoma desdiferenciado avanzado sin tratamiento previo o previamente tratados

CompletadoFase 3ClinicalTrials.gov

ID: NCT06058793Tipo: INTERVENTIONALInicio: 13 de dic de 2023Fin estimado: 12 de dic de 2025

Resumen

Este estudio está abierto a adultos con un tipo de cáncer llamado liposarcoma desdiferenciado (LDDS). Pueden unirse al estudio si sus tumores son positivos para MDM2. El propósito de este estudio es determinar si un medicamento llamado brigimadlin (BI 907828) es tolerado y ayuda a las personas con LDDS. Brigimadlin es un denominado inhibidor de MDM2 que se está desarrollando para tratar el cáncer. Los participantes toman brigimadlin en comprimido una vez cada 3 semanas. Los participantes pueden continuar tomando brigimadlin mientras se beneficien del tratamiento y puedan tolerarlo. Visitan el centro del estudio regularmente. En el centro del estudio, los médicos verifican regularmente la salud de los participantes y registran cualquier efecto no deseado. Los médicos también verifican regularmente el tamaño del tumor.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Provision of signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to any study-specific procedures, sampling, or analyses
Male or female patients ≥18 years old at the time of signature of the ICF
Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use two medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of \<1% per year when used consistently and correctly beginning at screening, during study participation, and until 6 months and 12 days after last dose for women and 102 days after last dose for men. A list of contraception methods meeting these criteria is provided in the patient information
Histologically documented locally advanced or metastatic, unresectable (i.e. surgery morbidity would outweigh potential benefits), progressive or recurrent Dedifferentiated liposarcoma (DDLPS), meeting the criteria for an open study cohort:
Cohort A: patient has not received prior systemic therapy for DDLPS in any setting (including adjuvant, neoadjuvant, maintenance, palliative)
Cohort B: patient has received any prior systemic therapy for DDLPS in any setting (including adjuvant, neoadjuvant, maintenance, palliative)
Written pathology report indicating the diagnosis of DDLPS with positive MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridisation (FISH) or next-generation sequencing (NGS)
Presence of at least 1 measurable target lesion according to RECIST version 1.1. In patients who only have 1 target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Criterios de exclusión

Known mutation in the TP53 gene (screening for TP53 status is not required)
Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of study treatment or planned within 6 months after screening
Previous administration of brigimadlin or any other MDM2-p53 or MDM4 regulator of p53 (MDM4/MDMX)-p53 antagonist
Previous treatment in study 1403-0008 (Brightline-1)
Having to receive, or intending to receive, restricted medications or any drug considered likely to interfere with the safe conduct of the study
Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or endpoint assessment
Unable to swallow the study treatment

Intervenciones

drug

Brigimadlin

Ubicaciones

Hospital Britanico de Buenos Aires

CABA, Argentina

Sanatorio Finochietto

CABA, Argentina

Hospital Italiano de Buenos Aires

CABA, Argentina

Instituto Medico Especializado Alexander Fleming

Ciudad Autonoma de Bs As, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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.

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