Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05218499
Ethics application status
Date submitted
18/01/2022
Date registered
1/02/2022

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
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
31/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/05/2026
Actual
Sample size
Target
Accrual to date
Final
401
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Prince of Wales Hospital-Randwick-66496 - 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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
China
State/province [21] 0 0
Beijing
Country [22] 0 0
China
State/province [22] 0 0
Changchun
Country [23] 0 0
China
State/province [23] 0 0
Chengdu
Country [24] 0 0
China
State/province [24] 0 0
Guangzhou
Country [25] 0 0
China
State/province [25] 0 0
Hangzhou
Country [26] 0 0
China
State/province [26] 0 0
Harbin
Country [27] 0 0
China
State/province [27] 0 0
Shanghai
Country [28] 0 0
China
State/province [28] 0 0
Wuhan
Country [29] 0 0
Czechia
State/province [29] 0 0
Brno
Country [30] 0 0
Czechia
State/province [30] 0 0
Olomouc
Country [31] 0 0
Czechia
State/province [31] 0 0
Prague 5
Country [32] 0 0
Denmark
State/province [32] 0 0
Herlev
Country [33] 0 0
Finland
State/province [33] 0 0
Helsinki
Country [34] 0 0
Finland
State/province [34] 0 0
Tampere
Country [35] 0 0
France
State/province [35] 0 0
Bordeaux
Country [36] 0 0
France
State/province [36] 0 0
Lille
Country [37] 0 0
France
State/province [37] 0 0
Lyon
Country [38] 0 0
France
State/province [38] 0 0
Marseille
Country [39] 0 0
France
State/province [39] 0 0
Paris
Country [40] 0 0
France
State/province [40] 0 0
Rennes
Country [41] 0 0
France
State/province [41] 0 0
Toulouse
Country [42] 0 0
France
State/province [42] 0 0
Villejuif
Country [43] 0 0
Germany
State/province [43] 0 0
Bad Saarow
Country [44] 0 0
Germany
State/province [44] 0 0
Berlin
Country [45] 0 0
Germany
State/province [45] 0 0
Dresden
Country [46] 0 0
Germany
State/province [46] 0 0
Essen
Country [47] 0 0
Germany
State/province [47] 0 0
Hamburg
Country [48] 0 0
Germany
State/province [48] 0 0
Hannover
Country [49] 0 0
Germany
State/province [49] 0 0
Mannheim
Country [50] 0 0
Germany
State/province [50] 0 0
München
Country [51] 0 0
Germany
State/province [51] 0 0
Stuttgart
Country [52] 0 0
Greece
State/province [52] 0 0
Athens
Country [53] 0 0
Greece
State/province [53] 0 0
Haidari
Country [54] 0 0
Greece
State/province [54] 0 0
Thessaloniki
Country [55] 0 0
Hong Kong
State/province [55] 0 0
Hong Kong
Country [56] 0 0
Italy
State/province [56] 0 0
Bergamo
Country [57] 0 0
Italy
State/province [57] 0 0
Candiolo (TO)
Country [58] 0 0
Italy
State/province [58] 0 0
Milano
Country [59] 0 0
Italy
State/province [59] 0 0
Napoli
Country [60] 0 0
Italy
State/province [60] 0 0
Orbassano (TO)
Country [61] 0 0
Italy
State/province [61] 0 0
Padova
Country [62] 0 0
Italy
State/province [62] 0 0
Palermo
Country [63] 0 0
Italy
State/province [63] 0 0
Roma
Country [64] 0 0
Japan
State/province [64] 0 0
Aichi, Nagoya
Country [65] 0 0
Japan
State/province [65] 0 0
Chiba, Kashiwa
Country [66] 0 0
Japan
State/province [66] 0 0
Fukuoka, Fukuoka
Country [67] 0 0
Japan
State/province [67] 0 0
Miyagi, Sendai
Country [68] 0 0
Japan
State/province [68] 0 0
Okayama, Okayama
Country [69] 0 0
Japan
State/province [69] 0 0
Osaka, Osaka
Country [70] 0 0
Japan
State/province [70] 0 0
Sapporo, Hokkaido
Country [71] 0 0
Japan
State/province [71] 0 0
Tokyo, Chuo-ku
Country [72] 0 0
Japan
State/province [72] 0 0
Tokyo, Koto-ku
Country [73] 0 0
Netherlands
State/province [73] 0 0
Amsterdam
Country [74] 0 0
Netherlands
State/province [74] 0 0
Leiden
Country [75] 0 0
Norway
State/province [75] 0 0
Oslo
Country [76] 0 0
Portugal
State/province [76] 0 0
Lisboa
Country [77] 0 0
Spain
State/province [77] 0 0
Barcelona
Country [78] 0 0
Spain
State/province [78] 0 0
L'Hospitalet de Llobregat
Country [79] 0 0
Spain
State/province [79] 0 0
Madrid
Country [80] 0 0
Spain
State/province [80] 0 0
Malaga
Country [81] 0 0
Spain
State/province [81] 0 0
Santiago de Compostela
Country [82] 0 0
Spain
State/province [82] 0 0
Zaragoza
Country [83] 0 0
Sweden
State/province [83] 0 0
Lund
Country [84] 0 0
Sweden
State/province [84] 0 0
Stockholm
Country [85] 0 0
Taiwan
State/province [85] 0 0
Taipei
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Cambridge
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Cardiff
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Headington
Country [89] 0 0
United Kingdom
State/province [89] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Once the time frame criteria given under number 4 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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05218499