Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma

April 15, 2024 updated by: Boehringer Ingelheim

Brightline-4: A Phase III Open-label, Single-arm, Multi-center Study to Assess the Safety and Efficacy of Brigimadlin (BI 907828) Treatment in Patients With Treatment-naïve or Pre-treated Advanced Dedifferentiated Liposarcoma

This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumours are positive for MDM2. The purpose of this study is to find out whether a medicine called brigimadlin (BI 907828) is tolerated by and helps people with DDLPS. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer.

Participants take brigimadlin as a tablet once every 3 weeks. Participants may continue to take brigimadlin as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check participants' health and take note of any unwanted effects. The doctors also regularly check tumour size.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
    • Victoria
      • Melbourne, Victoria, Australia, 3000
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
  • Japan
      • Aichi, Nagoya, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital
        • Contact:
      • Fukuoka, Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center
        • Contact:
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
      • Manchester, United Kingdom, M20 4BX
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
    • California
      • Beverly Hills, California, United States, 90212
      • Santa Monica, California, United States, 90403
    • Georgia
      • Athens, Georgia, United States, 30607
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • New York
      • Lake Success, New York, United States, 11042
      • New York, New York, United States, 10065
    • Tennessee
      • Germantown, Tennessee, United States, 38138
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84106
    • Washington
      • Spokane, Washington, United States, 99208
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert and The Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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 (ICH) - Good Clinical Practice (GCP) and local legislation prior to any study-specific procedures, sampling, or analyses
  2. Male or female patients ≥18 years old at the time of signature of the ICF
  3. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use two 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 study participation, and until 6 months and 12 days after last dose for women and 102 days after last dose for men. A list of contraception methods meeting these criteria is provided in the patient information

  4. Histologically documented locally advanced or metastatic, unresectable (i.e. surgery morbidity would outweigh potential benefits), progressive or recurrent Dedifferentiated liposarcoma (DDLPS), meeting the criteria for an open study cohort:

    • Cohort A: patient has not received prior systemic therapy for DDLPS in any setting (including adjuvant, neoadjuvant, maintenance, palliative)
    • Cohort B: patient has received any prior systemic therapy for DDLPS in any setting (including adjuvant, neoadjuvant, maintenance, palliative)
  5. Written pathology report indicating the diagnosis of DDLPS with positive MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridisation (FISH) or next-generation sequencing (NGS)
  6. Presence of at least 1 measurable target lesion according to RECIST version 1.1. In patients who only have 1 target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  8. Life expectancy ≥3 months at the start of treatment in the opinion of the investigator Further inclusion criteria apply.

Exclusion Criteria:

  1. Known mutation in the TP53 gene (screening for TP53 status is not required)
  2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of study treatment or planned within 6 months after screening
  3. Previous administration of brigimadlin or any other MDM2-p53 or MDM4 regulator of p53 (MDM4/MDMX)-p53 antagonist
  4. Previous treatment in study 1403-0008 (Brightline-1)
  5. Having to receive, or intending to receive, restricted medications or any drug considered likely to interfere with the safe conduct of the study
  6. Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or endpoint assessment
  7. Unable to swallow the study treatment
  8. Previous or concomitant malignancies other than the one treated in this study within the previous 2 years, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, or other malignancy that is considered cured by local treatment Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brigimadlin treatment
Drug: Brigimadlin
Brigimadlin
Other Names:
  • BI 907828

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Treatment-emergent adverse events (TEAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 during the entire treatment period
Time Frame: up to 23 months
up to 23 months
Occurrence of TEAEs with Grade ≥3 according to CTCAE version 5 during the entire treatment period
Time Frame: up to 23 months
up to 23 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of treatment-emergent serious adverse events (SAEs)
Time Frame: up to 23 months
up to 23 months
Occurrence of TEAEs leading to study treatment discontinuation
Time Frame: up to 23 months
up to 23 months
Occurrence of TEAEs leading to dose reduction
Time Frame: up to 23 months
up to 23 months
Occurrence of TEAEs leading to dose delay
Time Frame: up to 23 months
up to 23 months
Occurrence of TEAEs of special interest (adverse events of special interest [AESIs])
Time Frame: up to 23 months
up to 23 months
Objective response (OR)
Time Frame: up to 23 months
OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (based on investigator assessment) from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent
up to 23 months
Progression-free survival (PFS)
Time Frame: up to 23 months
PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST version 1.1, based on investigator assessment, or death from any cause
up to 23 months
Overall survival (OS)
Time Frame: up to 23 months
OS is defined as the time from treatment start until death from any cause
up to 23 months
Duration of objective response (DOR)
Time Frame: up to 23 months
DOR is defined as the time from first documented confirmed OR until the earliest date of disease progression or death among patients with confirmed OR (based on investigator assessment)
up to 23 months
Disease control (DC)
Time Frame: up to 23 months
DC is defined as a best overall response of CR, PR, or stable disease (SD) where best overall response is defined according to RECIST version 1.1 based on investigator assessment
up to 23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Estimated)

November 24, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1403-0019
  • 2023-504522-19-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing Time Frame

After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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