Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
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
Download to PDF
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
Date last updated
4/07/2025
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
Query!
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
Query!
Secondary ID [1]
0
0
2021-002392-20
Query!
Secondary ID [2]
0
0
1403-0008
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Liposarcoma, Dedifferentiated
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Sarcoma (also see 'Bone') - soft tissue
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Brigimadlin
Treatment: Drugs - Doxorubicin
Experimental: Brigimadlin 30 mg q3w - Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
Experimental: Brigimadlin 45 mg q3w - Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
Active comparator: Doxorubicin - Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Treatment: Drugs: Brigimadlin
Brigimadlin taken orally on day 1 of each 21-day cycle (q3w).
Treatment: Drugs: Doxorubicin
Intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free Survival (PFS)
Query!
Assessment method [1]
0
0
Progression-free survival (PFS) based on blinded central independent review. For each patient, PFS was defined as the time interval from randomization until tumor progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (solely based on blinded central independent review) or death from any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter. (Note: the appearance of one or more new lesions is also considered progression).
Query!
Timepoint [1]
0
0
Up to 20.6 months.
Query!
Secondary outcome [1]
0
0
Objective Response (OR)
Query!
Assessment method [1]
0
0
Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 (based on blinded central independent review) from the date of randomization until disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Query!
Timepoint [1]
0
0
Up to 20.6 months.
Query!
Secondary outcome [2]
0
0
Duration of Objective Response (DOR)
Query!
Assessment method [2]
0
0
Duration of objective response (DOR), defined as the time interval from first documented confirmed OR until disease progression or death among patients with confirmed OR (based on blinded central independent review), whichever occurs first.
Query!
Timepoint [2]
0
0
Up to 20.6 months.
Query!
Secondary outcome [3]
0
0
Disease Control (DC)
Query!
Assessment method [3]
0
0
Disease control (DC), defined as a best overall response of CR, PR, or stable disease (SD) according to RECIST version 1.1 (based on blinded central independent review). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Query!
Timepoint [3]
0
0
Up to 20.6 months.
Query!
Secondary outcome [4]
0
0
Change in Health-Related Quality of Life at Week 6 and 18
Query!
Assessment method [4]
0
0
Mean change from baseline to week 6 and 18 in the following European Organization for Research and Treatment on Cancer (EORTC) Quality of Life Core Questionnaire 30 items (QLQ-C30) scores: * Physical functioning (higher score is better) * Pain (higher score is worse) * Fatigue (higher score is worse) * Global health status / QoL (higher score is better) and the following scores obtained using items from the EORTC QLQ-C30 and EORTC Item Library (higher score is worse): * Fatigue symptoms * Fatigability * Fatigue impact * Pain descriptors * Pain impact All of the scales and single-item measures range in score from 0 to 100.
Query!
Timepoint [4]
0
0
Baseline (cycle 1 day 1), week 6 and week 18.
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
31/03/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
3/11/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
400
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Prince of Wales Hospital-Randwick-66496 - Randwick
Query!
Recruitment hospital [2]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [3]
0
0
Ashford Cancer Centre Research - Kurralta Park
Query!
Recruitment hospital [4]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [3]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [4]
0
0
3000 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Michigan
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Minnesota
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Missouri
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Nebraska
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Oregon
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Tennessee
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Texas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Utah
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Wisconsin
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Leuven
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
British Columbia
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Ontario
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Quebec
Query!
Country [21]
0
0
China
Query!
State/province [21]
0
0
Beijing
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Changchun
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Chengdu
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Guangzhou
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Hangzhou
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Harbin
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Shanghai
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Wuhan
Query!
Country [29]
0
0
Czechia
Query!
State/province [29]
0
0
Brno
Query!
Country [30]
0
0
Czechia
Query!
State/province [30]
0
0
Olomouc
Query!
Country [31]
0
0
Czechia
Query!
State/province [31]
0
0
Prague 5
Query!
Country [32]
0
0
Denmark
Query!
State/province [32]
0
0
Herlev
Query!
Country [33]
0
0
Finland
Query!
State/province [33]
0
0
Helsinki
Query!
Country [34]
0
0
Finland
Query!
State/province [34]
0
0
Tampere
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Bordeaux
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Lille
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Lyon
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Marseille
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Paris
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Rennes
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Toulouse
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Villejuif
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Bad Saarow
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Berlin
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Dresden
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Essen
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Hamburg
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Hannover
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Mannheim
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
München
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Stuttgart
Query!
Country [52]
0
0
Greece
Query!
State/province [52]
0
0
Athens
Query!
Country [53]
0
0
Greece
Query!
State/province [53]
0
0
Haidari
Query!
Country [54]
0
0
Greece
Query!
State/province [54]
0
0
Thessaloniki
Query!
Country [55]
0
0
Hong Kong
Query!
State/province [55]
0
0
Hong Kong
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Bergamo
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Candiolo (TO)
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Milano
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Napoli
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Orbassano (TO)
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Padova
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Palermo
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Roma
Query!
Country [64]
0
0
Japan
Query!
State/province [64]
0
0
Aichi, Nagoya
Query!
Country [65]
0
0
Japan
Query!
State/province [65]
0
0
Chiba, Kashiwa
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Fukuoka, Fukuoka
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Miyagi, Sendai
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Okayama, Okayama
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Osaka, Osaka
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Sapporo, Hokkaido
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Tokyo, Chuo-ku
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Tokyo, Koto-ku
Query!
Country [73]
0
0
Netherlands
Query!
State/province [73]
0
0
Amsterdam
Query!
Country [74]
0
0
Netherlands
Query!
State/province [74]
0
0
Leiden
Query!
Country [75]
0
0
Norway
Query!
State/province [75]
0
0
Oslo
Query!
Country [76]
0
0
Portugal
Query!
State/province [76]
0
0
Lisboa
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Barcelona
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
L'Hospitalet de Llobregat
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Madrid
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Malaga
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Santiago de Compostela
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Zaragoza
Query!
Country [83]
0
0
Sweden
Query!
State/province [83]
0
0
Lund
Query!
Country [84]
0
0
Sweden
Query!
State/province [84]
0
0
Stockholm
Query!
Country [85]
0
0
Taiwan
Query!
State/province [85]
0
0
Taipei
Query!
Country [86]
0
0
United Kingdom
Query!
State/province [86]
0
0
Cambridge
Query!
Country [87]
0
0
United Kingdom
Query!
State/province [87]
0
0
Cardiff
Query!
Country [88]
0
0
United Kingdom
Query!
State/province [88]
0
0
Headington
Query!
Country [89]
0
0
United Kingdom
Query!
State/province [89]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05218499
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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)
Query!
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.
Query!
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/99/NCT05218499/Prot_003.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/99/NCT05218499/SAP_004.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05218499
Download to PDF