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ACTIVE NOT RECRUITING

NCT06619509

PHASE2

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: A Phase II, Single-arm, Open-label, Long-term Safety Rollover Trial of Oral Brigimadlin in Patients With Solid Tumours

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-12-30

Completion Date

2030-12-30

Last Updated

2026-03-17

Healthy Volunteers

Conditions

Solid Tumours

Interventions

DRUG

Brigimadlin

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.

Locations (50)

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

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

Hospital Universitario 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (50)