Trial Title:
Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder
NCT ID:
NCT05512377
Condition:
Pancreatic Neoplasms
Solid Tumors
Biliary Tract Cancer
Lung Neoplasms
Bladder Cancer
Conditions: Official terms:
Neoplasms
Biliary Tract Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
brigimadlin
Description:
brigimadlin
Arm group label:
brigimadlin (BI 907828) treatment arm
Other name:
BI 907828
Summary:
This study is open to adults with advanced cancer in the biliary tract, pancreas, lung,
or bladder. This is a study for people for whom previous treatment was not successful or
no treatment exists.
The purpose of this study is to find out whether a medicine called BI 907828 helps people
with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called
MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828
as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as
they benefit from treatment and can tolerate it. They visit the study site regularly. At
the study site, doctors regularly check the size of the tumour and whether it has spread
to other parts of the body. The doctors also regularly check participants' health and
take note of any unwanted effects.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosis of a solid tumour which meets the criteria for an open trial cohort:
- Cohorts 1 and 1-CN (biliary tract adenocarcinoma): Locally advanced or
metastatic biliary tract adenocarcinoma (intra- and extrahepatic
cholangiocarcinoma, gallbladder cancer, and ampullary cancer).Patients must
have unresectable disease and have received all available conventional
therapies known to confer clinical benefit for their disease based on local
approved standards; or (in the opinion of the investigator) patients are
unlikely to tolerate or derive clinically meaningful benefit from appropriate
standard of care therapy.
- Cohort 2 (pancreatic ductal adenocarcinoma): Locally advanced or metastatic
pancreatic ductal adenocarcinoma. Patients must have unresectable disease and
have received all available conventional therapies known to confer clinical
benefit for their disease based on local approved standards.
- Cohort 3 (lung adenocarcinoma): Locally advanced or metastatic lung
adenocarcinoma. Patients must have unresectable disease and have received all
available conventional therapies known to confer clinical benefit for their
disease based on local approved standards.
- Cohort 4 (urothelial bladder cancer): Locally advanced or metastatic urothelial
bladder cancer. Patients must have unresectable disease and have received all
available conventional therapies known to confer clinical benefit for their
disease based on local approved standards.
- Written pathology report / molecular profiling report indicating Mouse double minute
2 homolog (MDM2) amplification or a copy number ≥8 and tumor protein 53 (TP53)
wild-type status. This must have been confirmed with a tissue-based test. A test
with liquid biopsy is not accepted.
- Archival tissue (formalin fixed paraffin embedded [FFPE] tumour blocks or slides)
must be provided for retrospective confirmation of MDM2 amplification and TP53
status.
- Presence of at least 1 measurable target lesion according to Response Evaluation
Criteria in Solid Tumours (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Patient must be willing to donate mandatory blood samples for the pharmacokinetics,
pharmacodynamics, and biomarker analyses
- Adequate organ function
- All toxicities related to previous anti-cancer therapies have resolved to ≤Common
Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment
administration (except for alopecia and amenorrhea / menstrual disorders which can
be of any grade and peripheral neuropathy which must be ≤CTCAE Grade 2).
- Life expectancy ≥3 months at the start of treatment in the opinion of the
investigator.
- 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 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.
Exclusion Criteria:
- Previous administration of brigimadlin (BI 907828) or any other MDM2-p53 or mouse
double minute 4 (MDMX, MDM4)-p53 antagonist.
- Active bleeding, significant risk of haemorrhage (e.g. previous severe
gastrointestinal bleeding, previous haemorrhagic stroke at any time), or current
bleeding disorder (e.g. haemophilia, von Willebrand disease).
- Major surgery (major according to the investigator's assessment) performed within 4
weeks prior to start of trial treatment or planned within 6 months after screening
(e.g. hip replacement).
- Clinically significant previous or concomitant malignancies in the opinion of the
investigator affecting the efficacy and/or outcome of the trial.
- 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.
- Any history of, or concomitant condition that, in the opinion of the investigator,
would compromise the patient's ability to comply with the trial or interfere with
the evaluation of the safety and efficacy of the trial drug.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern Cancer Center
Address:
City:
Mobile
Zip:
36608
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
University of Arizona
Address:
City:
Tucson
Zip:
85719
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
University of Southern California
Address:
City:
Los Angeles
Zip:
90033-9173
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Stanford Cancer Institute
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Providence Medical Foundation
Address:
City:
Santa Rosa
Zip:
95403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Rocky Mountain Cancer Centers
Address:
City:
Lone Tree
Zip:
80124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital
Address:
City:
Washington
Zip:
20016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Norton Cancer Institute, Downtown
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
University of Michigan Health System
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Nebraska Cancer Specialists
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Address:
City:
Mineola
Zip:
11501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Memorial Sloan-Kettering Cancer Center
Address:
City:
New York
Zip:
10022
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Oncology Associates of Oregon, PC
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Oregon Health and Sciences University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
University of Wisconsin
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Prince of Wales Hospital
Address:
City:
Randwick
Zip:
2031
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1800271035
Email:
australia@bitrialsupport.com
Facility:
Name:
ICON
Address:
City:
South Brisbane
Zip:
4101
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1800271035
Email:
australia@bitrialsupport.com
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1800271035
Email:
australia@bitrialsupport.com
Facility:
Name:
Ordensklinikum Linz GmbH - Barmherzige Schwestern
Address:
City:
Linz
Zip:
4020
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0800017900
Email:
oesterreich@bitrialsupport.com
Facility:
Name:
LK Wiener Neustadt
Address:
City:
Wiener Neustadt
Zip:
2700
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0800017900
Email:
oesterreich@bitrialsupport.com
Facility:
Name:
Edegem - UNIV UZ Antwerpen
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
080049616
Email:
belgique@bitrialsupport.com
Facility:
Name:
UNIV UZ Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
080049616
Email:
belgique@bitrialsupport.com
Facility:
Name:
INS Bergonie
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
HOP Beaujon
Address:
City:
Clichy
Zip:
92110
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
CTR Georges-François Leclerc
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
HOP Edouard Herriot
Address:
City:
Lyon
Zip:
69437
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
INS Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Carl Gustav Carus Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Krankenhaus Nordwest, Frankfurt
Address:
City:
Frankfurt
Zip:
60488
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Medizinische Hochschule Hannover
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Klinikum der Universität München - Campus Großhadern
Address:
City:
München
Zip:
81377
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Ulm
Address:
City:
Ulm
Zip:
89081
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Chiba, Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Kanagawa, Yokohama
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Tohoku University Hospital
Address:
City:
Miyagi, Sendai
Zip:
980-8574
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka, Osaka
Zip:
541-8567
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo, Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Japanese Foundation for Cancer Research
Address:
City:
Tokyo, Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Yamaguchi University Hospital
Address:
City:
Yamaguchi, Ube
Zip:
755-8505
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
135-710
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
King Abdul Aziz Medical City
Address:
City:
Riyadh
Zip:
11481
Country:
Saudi Arabia
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
8001263002
Email:
saudi@bitrialsupport.com
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Zip:
119074
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
8001207344
Email:
singapore@bitrialsupport.com
Facility:
Name:
Rainbow Oncology
Address:
City:
KwaZulu
Zip:
4126
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0800988886
Email:
southafrica@bitrialsupport.com
Facility:
Name:
Hospital Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Clínico de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
University Hospital Bern/Inselspital Bern
Address:
City:
Bern
Zip:
3010
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0800005900
Email:
suisse@bitrialsupport.com
Facility:
Name:
University Hospital Geneva
Address:
City:
Genève 14
Zip:
CH-1211
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0800005900
Email:
suisse@bitrialsupport.com
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0809092098
Email:
taiwan@bitrialsupport.com
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Zip:
404327
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0809092098
Email:
taiwan@bitrialsupport.com
Facility:
Name:
National Taiwan University Cancer Center
Address:
City:
Taipei
Zip:
106
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0809092098
Email:
taiwan@bitrialsupport.com
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0809092098
Email:
taiwan@bitrialsupport.com
Facility:
Name:
Songklanagarind Hospital
Address:
City:
Hat Yai
Zip:
90110
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1800019059
Email:
thai@bitrialsupport.com
Facility:
Name:
Srinagarind Hospital
Address:
City:
Muang
Zip:
40002
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1800019059
Email:
thai@bitrialsupport.com
Facility:
Name:
University College Hospital
Address:
City:
London
Zip:
WC1E 6AG
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08000514022
Email:
unitedkingdom@bitrialsupport.com
Start date:
November 25, 2022
Completion date:
November 25, 2026
Lead sponsor:
Agency:
Boehringer Ingelheim
Agency class:
Industry
Source:
Boehringer Ingelheim
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05512377
http://www.mystudywindow.com
