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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05218499
Collaborator
(none)
300
Enrollment
122
Locations
4
Arms
50.1
Anticipated Duration (Months)
2.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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 BI 907828 with doxorubicin in people with liposarcoma. 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 BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to 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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of BI 907828 Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma
Actual Study Start Date :
Mar 25, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
May 27, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: BI 907828 low dose

Phase II

Drug: BI 907828
BI 907828
Experimental: BI 907828 high dose

Phase II

Drug: BI 907828
BI 907828
Experimental: BI 907828 arm

Phase III

Drug: BI 907828
BI 907828
Active Comparator: Doxorubicin arm

Phase II/III

Drug: Doxorubicin
doxorubicin

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [Up to 30 months]

    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.

Secondary Outcome Measures

  1. Objective response (OR) [Up to 30 months]

    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.

  2. Duration of objective response (DOR) [Up to 30 months]

    defined as the time interval from first documented confirmed OR until disease progression or death among patients with confirmed objective response (based on blinded central independent review), whichever occurs first.

  3. Overall survival (OS) [Up to 50 months]

    defined as the time interval from randomization until death from any cause

  4. Disease control (DC) [Up to 30 months]

    defined as a best overall response of CR, PR, or stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (based on blinded central independent review).

  5. Change from baseline in QLQ-C30 (Quality of Life questionnaire C30) [Up to 30 months]

    The QLQ C30 rates the overall quality of life in cancer participants. 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function, symptoms and financial difficulties and 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life.

  6. Change from baseline in EQ-5D5L (European Quality of Life 5 dimensions 5 level) [Up to 30 months]

    The EQ-5D-5L is a standardized instrument to assess of health outcome through 5 Likert scale items. In the EQ-5D-5L VAS, the participant rates his or her general state of health at the time of the assessment on a scale from 0 to 100.

  7. Change from baseline in fatigue [Up to 30 months]

    Fatigue symptoms are assessed through 25 items selected from the European Organization for Research and Treatment of Cancer (EORTC) item library. Items use a 4-point scale (1=not at all to 4=very much) similar to the C30.

  8. Change from baseline in pain [Up to 30 months]

    Pain symptoms are assessed through 18 items selected from the EORTC item library. Items use a 4-point scale (1=not at all to 4=very much) similar to the C30.

  9. Change from baseline in Patient Global Impression of severity (PGIS) [Up to 30 months]

    The PGIS measures change in disease severity. The PGIS is scored on a 4-point Likert scale (1= none, 4= severe)

  10. Change from baseline in Patient Global Impression of Change (PGIC) [Up to 30 months]

    The PGIC measures change in clinical status. PGIC is scored on a 5-point Likert scale (1=much better, 5= much worse)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 well differentiated liposarcoma (WDLPS), treated within the previous 5 years, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, and prostate cancer.

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boehringer Ingelheim Investigational Site Birmingham Alabama United States 12345
2 Boehringer Ingelheim Investigational Site Tucson Arizona United States 12345
3 City of Hope Duarte California United States 91010
4 Boehringer Ingelheim Investigational Site Los Angeles California United States 12345
5 Boehringer Ingelheim Investigational Site San Diego California United States 12345
6 Sarcoma Oncology Center Santa Monica California United States 90403
7 Boehringer Ingelheim Investigational Site Jacksonville Florida United States 12345
8 Boehringer Ingelheim Investigational Site Atlanta Georgia United States 12345
9 Boehringer Ingelheim Investigational Site Boston Massachusetts United States 12345
10 University of Michigan Ann Arbor Michigan United States 48109
11 Boehringer Ingelheim Investigational Site Rochester Minnesota United States 12345
12 Boehringer Ingelheim Investigational Site Saint Louis Missouri United States 12345
13 Boehringer Ingelheim Investigational Site Buffalo New York United States 12345
14 Boehringer Ingelheim Investigational Site New York New York United States 12345
15 University Hospitals of Cleveland Cleveland Ohio United States 44106
16 Boehringer Ingelheim Investigational Site Columbus Ohio United States 12345
17 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma United States 12345
18 Boehringer Ingelheim Investigational Site Portland Oregon United States 12345
19 Boehringer Ingelheim Investigational Site Philadelphia Pennsylvania United States 12345
20 Boehringer Ingelheim Investigational Site Charleston South Carolina United States 12345
21 Boehringer Ingelheim Investigational Site Nashville Tennessee United States 12345
22 Boehringer Ingelheim Investigational Site Dallas Texas United States 12345
23 Boehringer Ingelheim Investigational Site Salt Lake City Utah United States 12345
24 Boehringer Ingelheim Investigational Site Seattle Washington United States 12345
25 Boehringer Ingelheim Investigational Site Milwaukee Wisconsin United States 12345
26 Boehringer Ingelheim Investigational Site Randwick New South Wales Australia 12345
27 Princess Alexandra Hospital Division of Cancer Service Woolloongabba Queensland Australia 4102
28 Ashford Cancer Centre Research Kurralta Park South Australia Australia 5037
29 Peter MacCallum Cancer Centre Melbourne Victoria Australia 3000
30 Boehringer Ingelheim Investigational Site Anderlecht Belgium 12345
31 UZ Leuven Leuven Belgium 3000
32 BC Cancer Agency Vancouver Cancer Centre Vancouver British Columbia Canada V5Z 4E6
33 Boehringer Ingelheim Investigational Site Ottawa Ontario Canada 12345
34 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9
35 Boehringer Ingelheim Investigational Site Hefei Anhui China 12345
36 Boehringer Ingelheim Investigational Site Beijing Beijing Municipality China 12345
37 Boehringer Ingelheim Investigational Site Beijing Beijing Municipality China 12345
38 Boehringer Ingelheim Investigational Site Guangzhou Guangdong China 12345
39 Boehringer Ingelheim Investigational Site Guangzhou Guangdong China 12345
40 Boehringer Ingelheim Investigational Site Haerbin Heilongjiang China 12345
41 Boehringer Ingelheim Investigational Site Changsha Hunan China 12345
42 Boehringer Ingelheim Investigational Site Changsha Hunan China 410013
43 Boehringer Ingelheim Investigational Site Changchun Jilin China 12345
44 Boehringer Ingelheim Investigational Site Shenyang Liaoning China 12345
45 Boehringer Ingelheim Investigational Site Shanghai Shanghai Municipality China 12345
46 Boehringer Ingelheim Investigational Site Chengdu Sichuan China 12345
47 Boehringer Ingelheim Investigational Site Tianjin Tianjin Municipality China 12345
48 Boehringer Ingelheim Investigational Site Hangzhou Zhejiang China 12345
49 Boehringer Ingelheim Investigational Site Beijing China 12345
50 Boehringer Ingelheim Investigational Site Wuhan China 12345
51 Boehringer Ingelheim Investigational Site Brno Czechia 12345
52 Boehringer Ingelheim Investigational Site Olomouc Czechia 12345
53 Boehringer Ingelheim Investigational Site Prague 5 Czechia 12345
54 Boehringer Ingelheim Investigational Site Aarhus N Denmark 12345
55 Boehringer Ingelheim Investigational Site Herlev Denmark 12345
56 Comprehensive Cancer Center Helsinki Finland 00290
57 FONK, Early Phase Oncology Research Unit Tampere Finland 33520
58 Institut Bergonie Bordeaux France 33076
59 Centre Oscar Lambret Lille France 59020
60 Centre Leon Berard Lyon France 69373
61 Boehringer Ingelheim Investigational Site Marseille France 12345
62 Hôpital Cochin Paris France 75014
63 Institut Universitaire du Cancer Toulouse Toulouse France 31059
64 Gustave Roussy,Cancer Campus Villejuif France 94805
65 Boehringer Ingelheim Investigational Site Bad Saarow Germany 12345
66 Boehringer Ingelheim Investigational Site Berlin Germany 12345
67 Boehringer Ingelheim Investigational Site Dresden Germany 12345
68 Boehringer Ingelheim Investigational Site Essen Germany 12345
69 Boehringer Ingelheim Investigational Site Hannover Germany 12345
70 Universitätsklinikum Mannheim GmbH Mannheim Germany 68167
71 Boehringer Ingelheim Investigational Site München Germany 12345
72 Boehringer Ingelheim Investigational Site Stuttgart Germany 12345
73 Boehringer Ingelheim Investigational Site Athens Greece 12345
74 Bioclinic Thessaloniki Oncology Clinic Thessaloniki Greece 54622
75 Boehringer Ingelheim Investigational Site Hong Kong Hong Kong 12345
76 Boehringer Ingelheim Investigational Site Dublin Ireland 12345
77 Boehringer Ingelheim Investigational Site Milano Lombardia Italy 12345
78 Istituo Di Candiolo Candiolo (TO) Piemonte Italy 10060
79 AO Univ. Policlinico P.Giaccone Palermo Sicilia Italy 90129
80 Boehringer Ingelheim Investigational Site Padova Veneto Italy 12345
81 Boehringer Ingelheim Investigational Site Bergamo Italy 12345
82 Policlinico Universitario Campus Bio-Medico Oncologia Medica Roma Italy 00128
83 Boehringer Ingelheim Investigational Site Aichi, Nagoya Japan 12345
84 Nagoya University Hospital Aichi, Nagoya Japan 466-8560
85 Boehringer Ingelheim Investigational Site Chiba, Kashiwa Japan 12345
86 Boehringer Ingelheim Investigational Site Fukuoka, Fukuoka Japan 12345
87 Tohoku University Hospital Miyagi, Sendai Japan 980-8574
88 Okayama University Hospital Okayama, Okayama Japan 700-8558
89 Osaka International Cancer Institute Osaka, Osaka Japan 541-8567
90 Hokkaido Cancer Center Sapporo, Hokkaido Japan 003-0804
91 Boehringer Ingelheim Investigational Site Tokyo, Chuo-ku Japan 12345
92 Boehringer Ingelheim Investigational Site Tokyo, Koto-ku Japan 12345
93 Antoni van Leeuwenhoek Ziekenhuis Amsterdam Netherlands 1066 CX
94 Boehringer Ingelheim Investigational Site Leiden Netherlands 12345
95 Boehringer Ingelheim Investigational Site Oslo Norway 12345
96 Boehringer Ingelheim Investigational Site Tromsø Norway 12345
97 Boehringer Ingelheim Investigational Site Lisboa Portugal 12345
98 Boehringer Ingelheim Investigational Site Porto Portugal 12345
99 Boehringer Ingelheim Investigational Site Badalona Barcelona Spain 12345
100 Hospital Duran i Reynals L'Hospitalet de Llobregat Barcelona Spain 08907
101 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08026
102 Boehringer Ingelheim Investigational Site Barcelona Spain 12345
103 Boehringer Ingelheim Investigational Site Madrid Spain 12345
104 Hospital Universitario Fundación Jiménez Díaz Madrid Spain 28040
105 Hospital Universitario La Paz Madrid Spain 28046
106 Hospital Universitario Virgen de la Victoria Malaga Spain 29010
107 Boehringer Ingelheim Investigational Site Zaragoza Spain 12345
108 Boehringer Ingelheim Investigational Site Göteborg Sweden 12345
109 Boehringer Ingelheim Investigational Site Lund Sweden 12345
110 Boehringer Ingelheim Investigational Site Stockholm Sweden 12345
111 Boehringer Ingelheim Investigational Site Taipei Taiwan 12345
112 Boehringer Ingelheim Investigational Site Taoyuan Taiwan 12345
113 Boehringer Ingelheim Investigational Site Adana Turkey 12345
114 Boehringer Ingelheim Investigational Site Ankara Turkey 12345
115 Boehringer Ingelheim Investigational Site Ankara Turkey 12345
116 Boehringer Ingelheim Investigational Site Edirne Turkey 12345
117 Boehringer Ingelheim Investigational Site Istanbul Turkey 12345
118 Boehringer Ingelheim Investigational Site Cambridge United Kingdom 12345
119 Boehringer Ingelheim Investigational Site Cardiff United Kingdom 12345
120 Boehringer Ingelheim Investigational Site Headington United Kingdom 12345
121 The Royal Marsden Hospital London United Kingdom SW3 6JJ
122 Boehringer Ingelheim Investigational Site Sheffield United Kingdom 12345

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05218499
Other Study ID Numbers:
  • 1403-0008
  • 2021-002392-20
First Posted:
Feb 1, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liposarcoma
Doxorubicin

Study Results

No Results Posted as of Aug 24, 2022