Resumen

Este estudio está abierto a adultos con tumores sólidos que hayan recibido al menos 4 ciclos de tratamiento con brigimadlin en un estudio previo. El objetivo de este estudio es determinar con qué tolerabilidad las personas con tumores sólidos toleran el tratamiento prolongado con brigimadlin. Brigimadlin es un denominado inhibidor de MDM2 que se encontraba en desarrollo para el tratamiento del cáncer. Todos los participantes toman brigimadlin en comprimidos una vez cada 3 semanas en el centro del estudio. En las visitas del estudio, los médicos controlan el estado de salud de los participantes y registran cualquier efecto no deseado. En algunas visitas, los médicos también verifican el tamaño del tumor y si se ha diseminado a otras partes del cuerpo. Los participantes permanecen en el estudio mientras se beneficien del tratamiento y puedan tolerarlo.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patient is ongoing on brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial').
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 - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 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 trial participation, and until 6 months and 12 days after the last dose for women and 102 days after the last dose for men. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information.
Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
Adequate organ function.
Patient is eligible to receive continued treatment according to the clinical trial protocol of the parent trial they are currently participating in. Patients currently experiencing a dose delay in the parent trial due to adverse events are eligible if recovery from the adverse event takes place within the allowed time window in the parent trial.

Criterios de exclusión

Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin.
Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Female patients who do not agree to the interruption of breastfeeding from the start of study treatment until 6 months and 12 days after the last dose of study treatment.
Patient has unacceptable toxicity on brigimadlin at the time of transition into this trial.
Patient has an adverse event (AE) which has caused a dose delay and has not recovered within the allowed time window in the parent trial.
Patient who has already required 2 dose reductions and would require a third dose reduction at trial entry, unless the investigator deems treatment continuation beneficial, and the third dose reduction is agreed in writing between the investigator and the sponsor.

Ensayo de extensión abierto, de fase II, de un solo brazo, para evaluar la seguridad a largo plazo de brigimadlin oral en pacientes con tumores sólidos

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Brigimadlin

Ubicaciones

Sanatorio Finochietto

Patrocinadores