DAREON™-7: En undersøgelse for at teste, hvor godt forskellige doser af BI 764532 ud over kemoterapi tolereres af mennesker med avanceret neuroendokrine kræftformer
DAREON™-7: Et fase I, åbent, dosiseskalerings- og udvidelsesforsøg til undersøgelse af sikkerhed og tolerabilitet af BI 764532 intravenøse infusioner i kombination med standardbehandling (platin og etoposid) i førstelinjebehandling af patienter med neuroendokrine karcinomer ( 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Brussels, Belgien, 1200
- Cliniques Universitaires Saint-Luc
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Edegem, Belgien, 2650
- Universitair Ziekenhuis Antwerpen
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Florida
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Miami, Florida, Forenede Stater, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Winship Cancer Institute
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- John Theurer Cancer Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
- University of Pittsburgh Medical Center
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Bron, Frankrig, 69500
- Hopital Louis Pradel
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Marseille, Frankrig, 13009
- INS Paoli-Calmettes
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Groningen, Holland, 9713 GZ
- Universitair Medisch Centrum Groningen
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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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Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spanien, 28046
- Hospital Universitario La Paz
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Gothenburg, Sverige, 413 46
- Sahlgrenska Universitetsjukhuset
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Uppsala, Sverige, 751 85
- Uppsala University Hospital
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München, Tyskland, 81377
- Klinikum der Universität München AÖR
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Tübingen, Tyskland, 72076
- Universitätsklinikum Tübingen
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Del B: BI 764532 + carboplatin + etoposid
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BI 764532
Andre navne:
Standard of care Standard of care |
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Eksperimentel: Del B: BI 764532 + cisplatin + etoposid
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BI 764532
Andre navne:
Standard of care Standard of care |
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Eksperimentel: Del A1: BI 764532 lav dosis + carboplatin + etoposid
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BI 764532
Andre navne:
Standard of care Standard of care |
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Eksperimentel: Del A1: BI 764532 mellemdosis + carboplatin + etoposid
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BI 764532
Andre navne:
Standard of care Standard of care |
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Eksperimentel: Del A1: BI 764532 høj dosis + carboplatin + etoposid
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BI 764532
Andre navne:
Standard of care Standard of care |
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Eksperimentel: Del A2: BI 764532 + carboplatin + etoposid
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BI 764532
Andre navne:
Standard of care Standard of care |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Del B: Forekomst af dosisbegrænsende toksiciteter (DLT'er) i løbet af behandlingen
Tidsramme: Op til 36 måneder.
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Op til 36 måneder.
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Del A1: Forekomst af dosisbegrænsende toksiciteter (DLT'er) i den maksimale tolererede dosis (MTD) evalueringsperiode
Tidsramme: Op til 21 dage.
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Op til 21 dage.
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Del A2: Reduceret monitorering: forekomsten af DLT'er under behandlingsperioden
Tidsramme: Op til 36 måneder.
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Op til 36 måneder.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Del A1: Forekomst af dosisbegrænsende toksiciteter (DLT'er) i løbet af behandlingsperioden
Tidsramme: Op til 36 måneder.
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Op til 36 måneder.
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Del A1: Forekomst af bivirkninger (AEs) i løbet af behandlingsperioden
Tidsramme: Op til 36 måneder.
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Op til 36 måneder.
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Del A2: Forekomst af bivirkninger (AEs) i løbet af behandlingsperioden
Tidsramme: Op til 36 måneder.
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Op til 36 måneder.
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Part B: Objective response (OR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Up to 36 months.
|
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.
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Organiske kemikalier
- Kulbrinter
- Kulbrinter, cyklisk
- Kulhydrater
- Podophyllotoxin
- Tetrahydronaphthalenes
- Naphthalenes
- Polycykliske aromatiske kulbrinter
- Kulbrinter, aromatisk
- Polycykliske forbindelser
- Glukosider
- Glycosider
- Uorganiske kemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinationskomplekser
- Platinforbindelser
- Etoposid
- Carboplatin
- Cisplatin
Andre undersøgelses-id-numre
- 1438-0007
- U1111-1292-1400 (Registry Identifier: WHO Registry)
- 2023-505870-13-00 (Registry Identifier: CTIS (EU))
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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
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