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JOURNAL ONKOLOGIE – STUDIE

Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder

Rekrutierend

NCT-Nummer:
NCT05512377

Studienbeginn:
November 2022

Letztes Update:
30.04.2024

Wirkstoff:
brigimadlin

Indikation (Clinical Trials):
Neoplasms, Biliary Tract Neoplasms, Lung Neoplasms, Pancreatic Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Boehringer Ingelheim

Collaborator:
-

Kontakt

Additional US locations available on demand. Please contact for options.
Kontakt:
Phone: 1-800-243-0127
» Kontaktdaten anzeigen

Studienlocations
(3 von 63)

Universitätsklinikum Carl Gustav Carus Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Leberkrebszentrum Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1
30625 Hannover
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Klinikum der Universität München - Campus Großhadern
81377 München
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Leberkrebszentrum Universitätsklinikum Ulm
Albert-Einstein-Allee 23
89081 Ulm
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
University of Southern California
90033-9173 Los Angeles
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 833-602-2368
E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen
Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital
20016 Washington
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 833-602-2368
E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
11501 Mineola
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 833-602-2368
E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
10016 New York
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 833-602-2368
E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen
The University of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 833-602-2368
E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen
Kaohsiung Medical University Chung-Ho Memorial Hospital
80756 Kaohsiung
TaiwanRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 0809092098
E-Mail: taiwan@bitrialsupport.com» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Objective response (OR) (Time Frame - Up to 30 months):
OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1.



Secondary outcome:

1. Duration of objective response (DOR) (Time Frame - Up to 30 months):
DOR is defined as the time from first documented confirmed objective response (OR) until the earliest date of disease progression or death among patients with confirmed objective response.

2. Progression-free survival (PFS) (Time Frame - Up to 30 months):
PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST version 1.1 or death from any cause, whichever occurs first.

3. Overall survival (OS) (Time Frame - Up to 50 months):
OS is defined as the time from treatment start until death from any cause.

4. Disease control (DC) (Time Frame - Up to 30 months):
DC is defined as a best overall response of CR, PR, or stable disease (SD) where best overall response is defined according to RECIST version 1.1.

5. Occurrence of treatment-emergent adverse events (AEs) during the on-treatment period (Time Frame - Up to 30 months)

6. Occurrence of treatment-emergent AEs leading to trial drug discontinuation during the on-treatment period (Time Frame - Up to 30 months)

7. Change from baseline in European Organisation for Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ)-C30 physical functioning domain score (Time Frame - Up to 30 months):
The QLQ-C30 comprises 30 questions. The QLQ-C30 incorporates both multi-items scales and single-item measures. These include 1 global health status/QoL scale, 5 functional scales, 3 symptoms scales and 6 single items to assess dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. 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.

8. Change from baseline in EORTC QLQ-C30 fatigue domain score (Time Frame - Up to 30 months):
It is part of QLQ-C30 and uses 4-point scale (1=not at all to 4=very much)

9. Change from baseline in EORTC QLQ-C30 role functioning domain score (Time Frame - Up to 30 months):
It is part of QLQ-C30 and uses 4-point scale (1=not at all to 4=very much)

10. Change from baseline in EORTC QLQ-BIL21 tiredness domain score (Time Frame - Up to 30 months):
The QLQ-BIL21 is specific for the assessment of quality of life in patients with cholangiocarcinoma and cancer of the gallbladder. It consists of 21 questions with a 4-point scale (1=not at all to 4=very much), and the tiredness domain is part of it.

Geprüfte Regime

  • brigimadlin (BI 907828):
    brigimadlin

Quelle: ClinicalTrials.gov


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