The trial is taking place at:
T

Tampere University Hospital | Tampere Heart Hospital

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Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma

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Boehringer Ingelheim

Status and phase

Active, not recruiting
Phase 3
Phase 2

Conditions

Liposarcoma, Dedifferentiated

Treatments

Drug: Brigimadlin (BI 907828)
Drug: Doxorubicin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05218499
1403-0008
2021-002392-20 (EudraCT Number)

Details and patient eligibility

About

This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. The purpose of this study is to compare a medicine called brigimadlin (BI 907828) with doxorubicin in people with liposarcoma. Brigimadlin (BI 907828) is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either brigimadlin (BI 907828) or doxorubicin. Every 3 weeks, participants take brigimadlin (BI 907828) as tablets or doxorubicin as an infusion into a vein. Participants can switch to brigimadlin (BI 907828) treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and can tolerate it. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Enrollment

400 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of signed and dated, written informed consent form (ICF) in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses. Male or female patients ≥18 years old at the time of signature of the informed consent form (ICF). 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 less than 1% per year when used consistently and correctly beginning at screening, during trial 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. Histologically proven locally advanced or metastatic, unresectable (surgery morbidity would outweigh potential benefits), progressive or recurrent dedifferentiated liposarcoma (DDLPS). Locally performed histopathological diagnosis will be accepted for entry into this trial but will be confirmed by independent pathological review while the patients receive treatment in this trial. Written pathology report indicating the diagnosis of DDLPS with positive mouse double minute 2 homolog (MDM2) immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization or next generation sequencing (NGS) must be available. Formalin fixed paraffin embedded tumor blocks or slides must be available for retrospective histopathological central review. Presence of at least one measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. In patients who only have one target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Patient must be willing to donate blood samples for the pharmacokinetics, pharmacodynamics, and tumor mutation analysis. Patient willing to undergo a mandatory tumor biopsy at the time point specified in the flowchart unless exempt. Adequate organ function.

Exclusion criteria

Known mutation in the TP53 gene (screening for TP53 status is not required). Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening. Prior systemic therapy for liposarcoma in any setting (including adjuvant, neoadjuvant, maintenance, palliative). Previous or concomitant malignancies other than DDLPS or WDLPS, treated within the previous 5 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. Previous treatment with anthracyclines in any setting (systemic treatment with other anticancer agents is allowed if completed at least 5 years prior to study entry with the exception of hormone therapy). Patients who must or intend to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial. Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable trial participant). Further exclusion criteria apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 4 patient groups

Brigimadlin (BI 907828) low dose
Experimental group
Description:
Phase II
Treatment:
Drug: Brigimadlin (BI 907828)
Brigimadlin (BI 907828) high dose
Experimental group
Description:
Phase II
Treatment:
Drug: Brigimadlin (BI 907828)
Brigimadlin (BI 907828) arm
Experimental group
Description:
Phase III
Treatment:
Drug: Brigimadlin (BI 907828)
Doxorubicin arm
Active Comparator group
Description:
Phase II/III
Treatment:
Drug: Doxorubicin

Trial contacts and locations

111

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Central trial contact

Boehringer Ingelheim; Additional US locations available on demand. Please contact for options.

Data sourced from clinicaltrials.gov

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