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

Last updated: April 2, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

All Solid Tumors

Treatment

Brigimadlin

Clinical Study ID

NCT06619509
1403-0032
2024-514177-21-00
U1111-1305-3484
  • Ages > 18
  • All Genders

Study Summary

This study is open to adults who participated in a previous clinical study with brigimadlin.

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 is being developed to treat cancer.

Participants are grouped in cohorts depending on their treatment in the previous study:

  • Cohort 1a got brigimadlin and continues treatment with brigimadlin

  • Cohort 1b got brigimadlin for 4 or less treatment cycles; each cycle was 3 weeks long

  • Cohort 2 received a comparator and gets brigimadlin for the first time

All participants take brigimadlin as tablets once every 3 weeks at the study site. Participants in the Cohorts 1b and 2 visit the sites more frequently. 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 Criteria

Inclusion

Inclusion criteria:

All patients:

  1. Patient is ongoing on brigimadlin treatment or qualifies for crossover tobrigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafterreferred to as the 'parent trial').

  2. Provision of signed and dated, written informed consent form (ICF) in accordancewith International Council for Harmonisation of Technical Requirements forPharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and locallegislation prior to any trial-specific procedures, sampling, or analyses.

  3. Women of childbearing potential (WOCBP) and men able to father a child must be readyand able to use 2 medically acceptable methods of birth control per ICH M3 (R2) thatresult in a low failure rate of <1% per year when used consistently and correctlybeginning at Screening, during trial participation, and until 6 months and 12 daysafter the last dose for women and 102 days after the last dose for men. A list ofcontraception methods meeting these criteria and instructions on the duration of useis provided in the participant information.

  4. Participants must be willing and able to comply with the scheduled visits, treatmentplan, lifestyle, laboratory tests, contraceptive guidelines, and other studyprocedures.

  5. Adequate organ function.

  6. All toxicities related to previous anti-cancer therapies have resolved CommonTerminology Criteria for Adverse Events (CTCAE) Grade ≤1 prior to trial treatmentadministration (except for alopecia and amenorrhea/menstrual disorders which can beany grade and peripheral neuropathy which must be CTCAE Grade ≤2). Cohort 1 only:

  7. Patient is eligible to receive continued treatment according to the clinical trialprotocol of the parent trial they are currently participating in. Patients currentlyexperiencing a dose delay in the parent trial due to adverse events are eligible ifrecovery from the adverse event takes place within the allowed time window in theparent trial. Cohort 2 only:

  8. Patient is eligible to receive crossover treatment according to the clinical trialprotocol of the parent trial they are currently participating in. Patients musttransition directly from the parent trial to this trial, with no further anti-cancertherapies except those that are allowed by the clinical trial protocol of the parenttrial.

Further inclusion criteria apply.

Exclusion

Exclusion criteria:

  1. Any medical condition which in the opinion of the investigator should exclude thepatient from receiving treatment with brigimadlin.

  2. Participants who must receive or intend to receive restricted medications or anydrug 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 startof study treatment until 6 months and 12 days after the last dose of studytreatment. Cohort 1 only:

  4. Patient has disease progression or unacceptable toxicity on brigimadlin at the timeof transition into this trial.

  5. Patient has an adverse event (AE) which has caused a dose delay and has notrecovered within the allowed time window in the parent trial.

  6. Patient who has already required 2 dose reductions and would require a third dosereduction at trial entry, unless the investigator deems treatment continuationbeneficial, and the third dose reduction is agreed between the investigator and thesponsor.

Further exclusion criteria apply.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Brigimadlin
Phase: 2
Study Start date:
December 30, 2024
Estimated Completion Date:
December 31, 2036

Connect with a study center

  • Sanatorio Finochietto

    Caba, C1120AAB
    Argentina

    Site Not Available

  • Prince of Wales Hospital-Randwick-66496

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Brussels - UNIV Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Edegem - UNIV UZ Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • H.S.J. Beneficência Portuguesa - São Paulo

    Sao Paulo, 01323-001
    Brazil

    Site Not Available

  • West China Hospital

    Chengdu, 610041
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060
    China

    Site Not Available

  • University Hospital Olomouc

    Olomouc, 77900
    Czechia

    Site Not Available

  • Copenhagen University Hospital, Rigshospitalet

    København Ø, 2100
    Denmark

    Site Not Available

  • CTR Leon Berard

    Lyon, 69373
    France

    Site Not Available

  • CTR Eugène Marquis

    Rennes, 35042
    France

    Site Not Available

  • Helios Klinikum Berlin-Buch

    Berlin, 13125
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Clinexpert Gyongyos

    Gyongyos, 3200
    Hungary

    Site Not Available

  • Sourasky Medical Center

    Tel-Aviv, 6423906
    Israel

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano, 20133
    Italy

    Site Not Available

  • Istituto Nazionale IRCCS Tumori Fondazione Pascale

    Napoli, 80131
    Italy

    Site Not Available

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128
    Italy

    Site Not Available

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395
    Japan

    Site Not Available

  • Kanagawa Cancer Center

    Kanagawa, Yokohama, 241-8515
    Japan

    Site Not Available

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, Okayama, 700-8558
    Japan

    Site Not Available

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045
    Japan

    Active - Recruiting

  • Nederlands Kanker Instituut

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo, N-0379
    Norway

    Site Not Available

  • Oncology Center-Maria Sklodowska-Curie Institute

    Warsaw, 02-781
    Poland

    Site Not Available

  • Hospital Vall d'Hebron-Barcelona-47683

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Quirónsalud Madrid

    Madrid, 28223
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hospital Clínico de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Karolinska Comprehensive Cancer Center

    Stockholm, 171 76
    Sweden

    Site Not Available

  • University Hospital Bern/Inselspital Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • The Royal Marsden Hospital, Chelsea

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • Precision NextGen Oncology

    Beverly Hills, California 90212
    United States

    Site Not Available

  • Sarcoma Oncology Center

    Santa Monica, California 90403
    United States

    Site Not Available

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