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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05218499




Registration number
NCT05218499
Ethics application status
Date submitted
18/01/2022
Date registered
1/02/2022
Date last updated
22/05/2024

Titles & IDs
Public title
Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma
Scientific title
Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of Brigimadlin (BI 907828) Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma
Secondary ID [1] 0 0
2021-002392-20
Secondary ID [2] 0 0
1403-0008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liposarcoma, Dedifferentiated 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Brigimadlin (BI 907828)
Treatment: Drugs - Doxorubicin

Experimental: Brigimadlin (BI 907828) low dose - Phase II

Experimental: Brigimadlin (BI 907828) high dose - Phase II

Experimental: Brigimadlin (BI 907828) arm - Phase III

Active Comparator: Doxorubicin arm - Phase II/III


Treatment: Drugs: Brigimadlin (BI 907828)
Brigimadlin (BI 907828)

Treatment: Drugs: Doxorubicin
doxorubicin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [1] 0 0
Objective response (OR)
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [2] 0 0
Duration of objective response (DOR)
Timepoint [2] 0 0
Up to 30 months
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
Up to 50 months
Secondary outcome [4] 0 0
Disease control (DC)
Timepoint [4] 0 0
Up to 30 months
Secondary outcome [5] 0 0
Change from baseline in QLQ-C30 (Quality of Life questionnaire C30)
Timepoint [5] 0 0
Up to week 18
Secondary outcome [6] 0 0
Change from baseline in EQ-5D5L (European Quality of Life 5 dimensions 5 level)
Timepoint [6] 0 0
Up to week 18
Secondary outcome [7] 0 0
Change from baseline in fatigue
Timepoint [7] 0 0
Up to week 18
Secondary outcome [8] 0 0
Change from baseline in pain
Timepoint [8] 0 0
Up to week 18
Secondary outcome [9] 0 0
Occurrence of treatment-emergent adverse events (AEs)
Timepoint [9] 0 0
Up to 30 months
Secondary outcome [10] 0 0
Occurrence of treatment-emergent AEs leading to study drug discontinuation
Timepoint [10] 0 0
Up to 30 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/05/2026
Actual
Sample size
Target
Accrual to date
Final
400
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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Arizona
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Nebraska
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Utah
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Wisconsin
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Leuven
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British Columbia
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State/province [19] 0 0
Ontario
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Beijing
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Roma
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Sapporo, Hokkaido
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Cambridge
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Headington
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05218499
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries