DAREON™-7: Een onderzoek om te testen hoe goed verschillende doses BI 764532 naast chemotherapie worden verdragen door mensen met gevorderde neuro-endocriene kankers
DAREON™-7: een fase I, open-label dosisescalatie- en uitbreidingsonderzoek om de veiligheid en verdraagbaarheid van BI 764532 intraveneuze infusies te onderzoeken in combinatie met standaardzorg (platina en etoposide) bij de eerstelijnsbehandeling van patiënten met neuro-endocriene carcinomen ( NEC)
This study is open to adults aged 18 and older or above legal age who have a specific type of advanced neuroendocrine cancer (NEC). Their tumours must be positive for a marker called DLL3.
The purpose of this study is to test a medicine called BI 764532 in addition to chemotherapy. The study has Part A1, Part A2, and Part B. Part A1 of this study aims to find out the highest dose of BI 764532 that people can tolerate in addition to chemotherapy. Part A2 of this study is to find out how well people tolerate a low dose of BI 764532 combined with the chemotherapy. The purpose of Part B is to find out how well people can tolerate BI 764532 in combination with different chemotherapies. Researchers also want to find out whether BI 764532 in combination with chemotherapy helps people with NEC.
Participants get different doses of BI 764532 as an infusion into a vein. In addition, they get platinum-based chemotherapy as infusions into a vein. Participants can continue treatment up to 3 years if they benefit from treatment and can tolerate it.
Participants visit their doctors regularly. During these visits, the doctors collect information about participants' health and take note of any unwanted effects. Doctors also regularly check the size of the tumour.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Brussels, België, 1200
- Cliniques Universitaires Saint-Luc
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Edegem, België, 2650
- Universitair Ziekenhuis Antwerpen
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München, Duitsland, 81377
- Klinikum der Universität München AÖR
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Tübingen, Duitsland, 72076
- Universitätsklinikum Tübingen
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Bron, Frankrijk, 69500
- Hopital Louis Pradel
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Marseille, Frankrijk, 13009
- INS Paoli-Calmettes
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Aichi, Nagoya, Japan, 464-8681
- Aichi Cancer Center Hospital
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Chiba, Kashiwa, Japan, 277-8577
- National Cancer Center Hospital East
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Osaka, Osaka, Japan, 541-8567
- Osaka International Cancer Institute
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Tokyo, Chuo-ku, Japan, 104-0045
- National Cancer Center Hospital
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Groningen, Nederland, 9713 GZ
- Universitair Medisch Centrum Groningen
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Barcelona, Spanje, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Spanje, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spanje, 28046
- Hospital Universitario La Paz
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Florida
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Miami, Florida, Verenigde Staten, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Winship Cancer Institute
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Northwestern University
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New Jersey
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Hackensack, New Jersey, Verenigde Staten, 07601
- John Theurer Cancer Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15232
- University of Pittsburgh Medical Center
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Gothenburg, Zweden, 413 46
- Sahlgrenska Universitetsjukhuset
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Uppsala, Zweden, 751 85
- Uppsala University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF)
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Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses
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Patients diagnosed with locally advanced or metastatic NEC of following subtypes:
- extrapulmonary neuroendocrine carcinomas (epNEC)
- pulmonary large cell NEC (LCNEC)
- neuroendocrine carcinomas (NEC) of unknown primary site
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Patients with tumours with mixed histologies for any above type are eligible only if neuroendocrine carcinoma/small tumour cells component is predominant and represent at least 50% of the overall tumour tissue
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
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Minimum life expectancy of 12 weeks
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At least one measurable lesion as defined per RECIST 1.1 within approximately 35 days prior to the first dose of BI 764532
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Patients with a history of asymptomatic Central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria:
- No radiotherapy (including whole brain radiation therapy, stereotactic radiotherapy or radiosurgery) within 7 days
- Are neurologically stable without the need for steroids or anti-convulsants for at least 7 days before first dose of BI 764532 as per local site assessment Further inclusion criteria apply.
Exclusion Criteria:
- Previous treatment in this trial
- Current enrolment in another investigational device or drug trial, or <30 days since ending another investigational device or drug trial(s)
- Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma or Grade 3 neuroendocrine tumour
- Presence of leptomeningeal carcinomatosis
- Previous treatment with DLL3-targeting T cell engagers and cell therapies
- Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532
- Major surgery (major according to the investigator's assessment) within 28 days prior to first administration of BI 764532 or planned during treatment period, e.g. hip replacement Any documented active or suspected malignancy or history of malignancy within 5 years prior to Screening (other than the target indication or well differentiated neuroendocrine tumour (NET) stages of the target indication in case of transformed tumors), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix Further exclusion criteria apply.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Deel B: BI 764532 + carboplatine + etoposide
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BI 764532
Andere namen:
Standard of care Standard of care |
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Experimenteel: Deel B: BI 764532 + cisplatine + etoposide
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BI 764532
Andere namen:
Standard of care Standard of care |
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Experimenteel: Part A1: BI 764532 lage dosis + carboplatine + etoposide
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BI 764532
Andere namen:
Standard of care Standard of care |
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Experimenteel: Deel A1: BI 764532 gemiddelde dosis + carboplatine + etoposide
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BI 764532
Andere namen:
Standard of care Standard of care |
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Experimenteel: Deel A1: BI 764532 hoge dosis + carboplatine + etoposide
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BI 764532
Andere namen:
Standard of care Standard of care |
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Experimenteel: Deel A2: BI 764532 + carboplatine + etoposide
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BI 764532
Andere namen:
Standard of care Standard of care |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Deel B: Het optreden van dosisbeperkende toxiciteiten (DLT's) tijdens de behandelingsperiode
Tijdsspanne: Tot 36 maanden.
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Tot 36 maanden.
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Deel A1: Voorkomen van dosisbeperkende toxiciteit (DLT) in de evaluatieperiode voor de maximaal getolereerde dosis (MTD)
Tijdsspanne: Tot 21 dagen.
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Tot 21 dagen.
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Deel A2: Gereduceerde monitoring: het optreden van DLT's tijdens de behandelperiode
Tijdsspanne: Tot 36 maanden.
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Tot 36 maanden.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Deel A1: Voorkomen van dosislimiettoxiciteit (DLT) tijdens de behandelperiode
Tijdsspanne: Tot 36 maanden.
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Tot 36 maanden.
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Partij A1: Voorkomen van ongewenste voorvallen (AEs) tijdens de behandelingsperiode
Tijdsspanne: Tot 36 maanden.
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Tot 36 maanden.
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Deel A2: Voorkomen van ongewenste voorvallen (AE) tijdens de behandelingsperiode
Tijdsspanne: Tot 36 maanden.
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Tot 36 maanden.
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Part B: Objective response (OR)
Tijdsspanne: Up to 36 months.
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Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator's assessment) from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent. |
Up to 36 months.
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Part B: Duration of response (DoR)
Tijdsspanne: Up to 36 months.
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Duration of response (DoR), defined as the time from first documented confirmed objective response (OR) according to RECIST 1.1 (based on investigator's assessment) until the earliest date of disease progression or death among participants with confirmed objective response OR |
Up to 36 months.
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Part A2: Objective response (OR)
Tijdsspanne: Up to 36 months.
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Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator's assessment) from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent. |
Up to 36 months.
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Organische chemicaliën
- Koolwaterstoffen
- Koolwaterstoffen, cyclisch
- Koolhydraten
- Podophyllotoxine
- Tetrahydronaftalenes
- Naftalenen
- Polycyclische aromatische koolwaterstoffen
- Koolwaterstoffen, aromatisch
- Polycyclische verbindingen
- Glucosiden
- Glycosiden
- Anorganische chemicaliën
- Chloorverbindingen
- Stikstofverbindingen
- Coördinatiecomplexen
- Platinumverbindingen
- Etoposide
- Carboplatine
- Cisplatine
Andere studie-ID-nummers
- 1438-0007
- U1111-1292-1400 (Register-ID: WHO Registry)
- 2023-505870-13-00 (Register-ID: CTIS (EU))
- 2023 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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