A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine
NCT ID: NCT06619509
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2024-12-30
2030-12-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brigimadlin
Brigimadlin
Brigimadlin
Interventions
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Brigimadlin
Brigimadlin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Precision NextGen Oncology
Beverly Hills, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mayo Clinic Cancer Center
Jacksonville, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Cancer Specialists-Omaha-69066
Omaha, Nebraska, United States
Northwell Health
Lake Success, New York, United States
West Cancer Center & Research Institute
Germantown, Tennessee, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Sanatorio Finochietto
CABA, , Argentina
Prince of Wales Hospital-Randwick-66496
Randwick, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Sun Yat-Sen University Cancer Center
Guangzhou, , China
University Hospital Olomouc
Olomouc, , Czechia
Copenhagen University Hospital, Rigshospitalet
København Ø, , Denmark
CTR Leon Berard
Lyon, , France
CTR Eugène Marquis
Rennes, , France
Helios Klinikum Berlin-Buch
Berlin, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Clinexpert Gyongyos
Gyöngyös, , Hungary
Sourasky Medical Center
Tel Aviv, , Israel
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Oncologico Veneto IRCCS
Padua, , Italy
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, , Japan
Kyushu University Hospital
Fukuoka, Fukuoka, , Japan
Kanagawa Cancer Center
Kanagawa, Yokohama, , Japan
Tohoku University Hospital
Miyagi, Sendai, , Japan
Okayama University Hospital
Okayama, Okayama, , Japan
Osaka International Cancer Institute
Osaka, Osaka, , Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, , Japan
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, , Norway
Oncology Center-Maria Sklodowska-Curie Institute
Warsaw, , Poland
Hospital Miguel Servet
Aragon, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Clínico de Santiago
Santiago de Compostela, , Spain
Karolinska Comprehensive Cancer Center
Stockholm, , Sweden
Taipei Veterans General Hospital
Taipei, , Taiwan
Addenbrooke's Hospital
Cambridge, , United Kingdom
University College Hospital
London, , United Kingdom
The Royal Marsden Hospital, Chelsea
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Related Links
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Related Info
Other Identifiers
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2024-514177-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1305-3484
Identifier Type: REGISTRY
Identifier Source: secondary_id
1403-0032
Identifier Type: -
Identifier Source: org_study_id