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Clinical Trials in the USA / NCT06619509
Active, not recruiting Phase 2

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

NCT06619509 · tracked via the Priya Life Science USA tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 2
Started
2024-12-30
Last updated
2026-09-01

Condition(s) studied

Solid Tumours

Investigational drug(s) / intervention(s)

Brigimadlin

Brigimadlin: Brigimadlin

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
Precision NextGen Oncology Beverly Hills California
Sarcoma Oncology Center Santa Monica California
Yale Cancer Center New Haven Connecticut
Mayo Clinic Cancer Center Jacksonville Florida
Washington University School of Medicine St Louis Missouri
Nebraska Cancer Specialists-Omaha-69066 Omaha Nebraska
Northwell Health Lake Success New York
West Cancer Center & Research Institute Germantown Tennessee
Henry-Joyce Cancer Clinic Nashville Tennessee
The University of Texas MD Anderson Cancer Center Houston Texas
Utah Cancer Specialists Cancer Center Salt Lake City Utah
Fred Hutchinson Cancer Research Center Seattle Washington
University of Wisconsin Madison Wisconsin
Sanatorio Finochietto CABA Argentina
Prince of Wales Hospital-Randwick-66496 Randwick New South Wales
Princess Alexandra Hospital Woolloongabba Queensland
Cliniques Universitaires Saint-Luc Brussels Belgium
UZ Leuven Leuven Belgium
Arthur J. E. Child Comprehensive Cancer Centre Calgary Alberta
Princess Margaret Cancer Centre Toronto Ontario
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 Padova 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

+ 10 more sites — see the full list on the official registry below.

More Boehringer Ingelheim trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06619509 on ClinicalTrials.gov ↗ ← All trials in the USA