Active, Not Recruiting

Phase 2
Age: 18Years +
All Genders
ID06619509

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

Led by Boehringer Ingelheim · Updated on 2026-04-14

90

Participants Needed

50

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 50 locations

1

Precision NextGen Oncology

Beverly Hills, California, United States, 90212

Status Unknown

2

Sarcoma Oncology Center

Santa Monica, California, United States, 90403

Status Unknown

3

Yale Cancer Center

New Haven, Connecticut, United States, 06511

Status Unknown

4

Mayo Clinic Cancer Center

Jacksonville, Florida, United States, 32224

Status Unknown

5

Washington University School of Medicine

St Louis, Missouri, United States, 63108

Status Unknown

6

Nebraska Cancer Specialists-Omaha-69066

Omaha, Nebraska, United States, 68130

Status Unknown

7

Northwell Health

Lake Success, New York, United States, 11042

Status Unknown

8

West Cancer Center & Research Institute

Germantown, Tennessee, United States, 38138

Status Unknown

9

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States, 37232

Status Unknown

10

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Status Unknown

11

Utah Cancer Specialists Cancer Center

Salt Lake City, Utah, United States, 84106

Status Unknown

12

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

Status Unknown

13

University of Wisconsin

Madison, Wisconsin, United States, 53792

Status Unknown

14

Sanatorio Finochietto

CABA, Argentina, C1120AAB

Status Unknown

15

Prince of Wales Hospital-Randwick-66496

Randwick, New South Wales, Australia, 2031

Status Unknown

16

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Status Unknown

17

Cliniques Universitaires Saint-Luc

Brussels, Belgium, 1200

Status Unknown

18

UZ Leuven

Leuven, Belgium, 3000

Status Unknown

19

Arthur J. E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada, T2N 5G2

Status Unknown

20

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Status Unknown

21

Sun Yat-Sen University Cancer Center

Guangzhou, China, 510060

Status Unknown

22

University Hospital Olomouc

Olomouc, Czechia, 77900

Status Unknown

23

Copenhagen University Hospital, Rigshospitalet

København Ø, Denmark, 2100

Status Unknown

24

CTR Leon Berard

Lyon, France, 69373

Status Unknown

25

CTR Eugène Marquis

Rennes, France, 35042

Status Unknown

26

Helios Klinikum Berlin-Buch

Berlin, Germany, 13125

Status Unknown

27

Universitätsklinikum Tübingen

Tübingen, Germany, 72076

Status Unknown

28

Clinexpert Gyongyos

Gyöngyös, Hungary, 3200

Status Unknown

29

Sourasky Medical Center

Tel Aviv, Israel, 6423906

Status Unknown

30

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy, 20133

Status Unknown

31

Istituto Oncologico Veneto IRCCS

Padova, Italy, 35128

Status Unknown

32

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan, 811-1395

Status Unknown

33

Kyushu University Hospital

Fukuoka, Fukuoka, Japan, 812-8582

Status Unknown

34

Kanagawa Cancer Center

Kanagawa, Yokohama, Japan, 241-8515

Status Unknown

35

Tohoku University Hospital

Miyagi, Sendai, Japan, 980-8574

Status Unknown

36

Okayama University Hospital

Okayama, Okayama, Japan, 700-8558

Status Unknown

37

Osaka International Cancer Institute

Osaka, Osaka, Japan, 541-8567

Status Unknown

38

National Cancer Center Hospital

Tokyo, Chuo-ku, Japan, 104-0045

Status Unknown

39

Oslo Universitetssykehus HF, Radiumhospitalet

Oslo, Norway, N-0379

Status Unknown

40

Oncology Center-Maria Sklodowska-Curie Institute

Warsaw, Poland, 02-781

Status Unknown

41

Hospital Universitario Miguel Servet

Aragon, Spain, 50009

Status Unknown

42

Fundación Jiménez Díaz

Madrid, Spain, 28040

Status Unknown

43

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status Unknown

44

Hospital Universitario HM Sanchinarro

Madrid, Spain, 28050

Status Unknown

45

Hospital Clínico de Santiago

Santiago de Compostela, Spain, 15706

Status Unknown

46

Karolinska Comprehensive Cancer Center

Stockholm, Sweden, SE-171 76

Status Unknown

47

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Status Unknown

48

Addenbrooke's Hospital

Cambridge, United Kingdom, CB2 0QQ

Status Unknown

49

University College Hospital

London, United Kingdom, NW12PQ

Status Unknown

50

The Royal Marsden Hospital, London

London, United Kingdom, SW3 6JJ

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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