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A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine
50 patients around the world
Available in Spain, Brazil, Argentina
Boehringer Ingelheim
6Research sites
50Patients around the world
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Patient is ongoing on brigimadlin treatment or qualifies for crossover to brigimadlin treatment in any trial sponsored by Boehringer Ingelheim.Provision of signed and dated, written informed consent form in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice and local legislation prior to any trial-specific procedures, sampling, or analyses.Women of childbearing potential 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.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.All toxicities related to previous anti-cancer therapies have resolved Common Terminology Criteria for Adverse Events Grade ≤1 prior to trial treatment administration.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.Patient is eligible to receive crossover treatment according to the clinical trial protocol of the parent trial they are currently participating in.Patients must transition directly from the parent trial to this trial, with no further anti-cancer therapies except those that are allowed by the clinical trial protocol of the parent trial.
- 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 disease progression or unacceptable toxicity on brigimadlin at the time of transition into this trial.Patient has an adverse event 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 between the investigator and the sponsor.
Sites
Sanatorio Finochietto
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Recruiting
Hospital de Clínicas - Universidade Estadual de Campinas - UNICAMP
Recruiting
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Recruiting
A Beneficência Portuguesa de São Paulo
Recruiting
Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
Recruiting
StudyCARTHEDRALL
SponsorBoehringer Ingelheim
Study typeInterventional
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06619509
