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

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

March 31, 2022

Primary Completion Date

April 16, 2024

Study Completion Date

November 28, 2025

Conditions
Liposarcoma, Dedifferentiated
Interventions
DRUG

Brigimadlin

Brigimadlin taken orally on day 1 of each 21-day cycle (q3w).

DRUG

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).

Trial Locations (109)

100

National Taiwan University Hospital, Taipei

2031

Prince of Wales Hospital-Randwick-66496, Randwick

2730

Herlev and Gentofte Hospital, Herlev

3000

Peter MacCallum Cancer Centre, Melbourne

UZ Leuven, Leuven

4102

Princess Alexandra Hospital, Woolloongabba

5037

Ashford Cancer Centre Research, Kurralta Park

10043

AOU San Luigi Gonzaga, Orbassano (TO)

10060

Istituto Di Candiolo, Candiolo (TO)

11217

Taipei Veterans General Hospital, Taipei

12462

"Attikon University General Hospital of Attica", Haidari

13125

Helios Klinikum Berlin-Buch, Berlin

13385

HOP Timone, Marseille

15526

Helios Klinikum Bad Saarow, Bad Saarow

15706

Hospital Clínico de Santiago, Santiago de Compostela

17177

Karolinska Universitetssjukhuset Stockholm, Stockholm

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

22185

Skånes universitetssjukhus, Lund

22763

Asklepios Kliniken GmbH & Co. KGaA, Hamburg

24125

Humanitas Gavazzeni, Bergamo

28007

Hospital General Universitario Gregorio Marañón, Madrid

28040

Fundación Jiménez Díaz, Madrid

28046

Hospital Universitario La Paz, Madrid

28050

Hospital Universitario HM Sanchinarro, Madrid

29010

Hospital Virgen de la Victoria, Málaga

30322

Winship Cancer Institute, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

31059

INS Claudius Regaud IUCT-Oncopole, Toulouse

32224

Mayo Clinic Cancer Center, Jacksonville

33000

INS Bergonie, Bordeaux

33520

Tampere University Hospital, Tampere

35042

CTR Eugène Marquis, Rennes

35128

Istituto Oncologico Veneto IRCCS, Padua

35233

University of Alabama at Birmingham, Birmingham

37232

Henry-Joyce Cancer Clinic, Nashville

44106

University Hospitals of Cleveland, Cleveland

45147

Universitätsklinikum Essen AöR, Essen

48109

University of Michigan Health System, Ann Arbor

50009

Hospital Miguel Servet, Zaragoza

53226

Froedtert and The Medical College of Wisconsin, Milwaukee

54622

Bioclinic Thessaloniki, Thessaloniki

55905

Mayo Clinic, Rochester, Rochester

59020

CTR Oscar Lambret, Lille

63110

Barnes-Jewish Hospital, St Louis

65653

Masaryk Memorial Cancer Institute, Brno

68114

Nebraska Cancer Specialists-Omaha-69502, Omaha

68167

Universitätsklinikum Mannheim GmbH, Mannheim

69373

CTR Leon Berard, Lyon

70376

Robert Bosch Gesellschaft für medizinische Forschung mbH, Stuttgart

75014

HOP Cochin, Paris

75390

University of Texas Southwestern Medical Center, Dallas

77900

University Hospital Olomouc, Olomouc

80131

Istituto Nazionale IRCCS Tumori Fondazione Pascale, Napoli

81377

Klinikum der Universität München AÖR, München

84112

Huntsman Cancer Institute, Salt Lake City

85719

University of Arizona, Tucson

90033

University of Southern California, Los Angeles

90129

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo

90212

Precision NextGen Oncology, Beverly Hills

90403

Sarcoma Oncology Center, Santa Monica

91010

City of Hope-Duarte-56419, Duarte

94805

INS Gustave Roussy, Villejuif

97239

Oregon Health and Sciences University, Portland

100021

Cancer Hospital of Chinese Academy of Medical Science, Beijing

100142

Beijing Cancer Hospital, Beijing

130021

The First Hospital of Jilin University, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200032

Zhongshan Hospital Affiliated to Fudan University, Shanghai

310022

Zhejiang Cancer Hospital, Hangzhou

430022

Wuhan Union Hospital, Wuhan

510060

Sun Yat-Sen University Cancer Center, Guangzhou

610041

West China Hospital of Sichuan University, Chengdu

02114

Massachusetts General Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

V5Z 4E6

BC Cancer Agency - Vancouver, Vancouver

K1H 8L6

The Ottawa Hospital, Ottawa

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H1T 2M4

Maisonneuve-Rosemont Hospital, Montreal

150 06

Motol University Hospital, Prague

00290

HUCH Comprehensive Cancer Center, building 2, Helsinki

01307

Technische Universität Dresden, Dresden

115 27

Hippokration General Hospital of Athen, Athens

Unknown

Prince of Wales Hospital-Hong Kong-20715, Hong Kong

00128

Università Campus Bio-Medico - ROMA, Roma

464-8681

Aichi Cancer Center Hospital, Aichi, Nagoya

466-8560

Nagoya University Hospital, Aichi, Nagoya

277-8577

National Cancer Center Hospital East, Chiba, Kashiwa

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka, Fukuoka

812-8582

Kyushu University Hospital, Fukuoka, Fukuoka

980-8574

Tohoku University Hospital, Miyagi, Sendai

700-8558

Okayama University Hospital, Okayama, Okayama

541-8567

Osaka International Cancer Institute, Osaka, Osaka

003-0804

Hokkaido Cancer Center, Sapporo, Hokkaido

104-0045

National Cancer Center Hospital, Tokyo, Chuo-ku

135-8550

Japanese Foundation for Cancer Research, Tokyo, Koto-ku

1066 CX

Nederlands Kanker Instituut, Amsterdam

2333 ZA

Leids Universitair Medisch Centrum (LUMC), Leiden

N-0379

Oslo Universitetssykehus HF, Radiumhospitalet, Oslo

1099-023

IPO Lisboa Francisco Gentil, EPE, Lisbon

1649-035

ULS de Santa Maria, E.P.E, Lisbon

08026

Hospital Santa Creu i Sant Pau, Barcelona

08035

Hospital Universitari Vall D Hebron, Barcelona

08907

Hospital Duran i Reynals, L'Hospitalet de Llobregat

06200

Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara

CB2 0QQ

Addenbrooke's Hospital, Cambridge

CF14 2TL

Velindre Cancer Centre, Cardiff

OX3 9DS

Churchill Hospital, Headington

NW1 2BU

University College Hospital, London

SW3 6JJ

The Royal Marsden Hospital, Chelsea, London

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT05218499 - Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma | Biotech Hunter | Biotech Hunter