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Активно (без набиране) Фаза 2 NCT06619509

A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Solid Tumours

Спонсор: Boehringer Ingelheim

Налично на: БГ
Обобщение
This study is open to adults with solid tumours who received at least 4 cycles of treatment with brigimadlin in a previous study. The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin. Brigimadlin is a so-called MDM2 inhibitor that was being developed to treat cancer. All participants take brigimadlin as tablets once every 3 weeks at the study site. At study visits, doctors check participants' health and take note of any unwanted effects. At some study visits, doctors also check the size of the tumour and whether it has spread to other parts of the body. Participants are in the study as long as they benefit from treatment and can tolerate it.
Кой може да участва
Inclusion criteria: 1. Patient is ongoing on brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial'). 2. 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. 3. 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. 4. Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures. 5. Adequate organ function. 6. 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. Exclusion criteria: 1. Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin. 2. Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial. 3. 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. 4. Patient has unacceptable toxicity on brigimadlin at the time of transition into this trial. 5. 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. 6. 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. Further exclusion criteria apply.
Места на провеждане 19
Argentina (1)
Sanatorio Finochietto
CABA
Австралия (1)
Prince of Wales Hospital-Randwick-66496
Randwick , New South Wales
Белгия (1)
Cliniques Universitaires Saint-Luc
Brussels
Канада (1)
Arthur J. E. Child Comprehensive Cancer Centre
Calgary , Alberta
Китай (1)
Sun Yat-Sen University Cancer Center
Guangzhou
Чехия (1)
University Hospital Olomouc
Olomouc
Дания (1)
Copenhagen University Hospital, Rigshospitalet
København Ø
Франция (1)
CTR Leon Berard
Lyon
Унгария (1)
Clinexpert Gyongyos
Gyöngyös
Израел (1)
Sourasky Medical Center
Tel Aviv
Италия (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Япония (1)
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka
Норвегия (1)
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo
Полша (1)
Oncology Center-Maria Sklodowska-Curie Institute
Warsaw
Испания (1)
Hospital Universitario Miguel Servet
Aragon
Швеция (1)
Karolinska Comprehensive Cancer Center
Stockholm
Taiwan (1)
Taipei Veterans General Hospital
Taipei
Великобритания (1)
Addenbrooke's Hospital
Cambridge
САЩ (1)
Precision NextGen Oncology
Beverly Hills , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
30.12.2024
Крайна дата
30.12.2030
Регистрационен номер
NCT06619509
Източник
anzctr
Запитване за медицински туризъм

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