DAREON™-7: En studie for å teste hvor godt ulike doser av BI 764532 i tillegg til kjemoterapi tolereres av personer med avanserte nevroendokrine kreftformer
DAREON™-7: En fase I, åpen, doseeskalerings- og utvidelsesstudie for å undersøke sikkerhet og tolerabilitet av BI 764532 intravenøse infusjoner i kombinasjon med standardbehandling (platina og etoposid) i førstelinjebehandling av pasienter med nevroendokrine karsinomer ( 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
-
Brussels, Belgia, 1200
- Cliniques Universitaires Saint-Luc
-
Edegem, Belgia, 2650
- Universitair Ziekenhuis Antwerpen
-
-
-
-
Florida
-
Miami, Florida, Forente stater, 33136
- University of Miami
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30322
- Winship Cancer Institute
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60611
- Northwestern University
-
-
New Jersey
-
Hackensack, New Jersey, Forente stater, 07601
- John Theurer Cancer Center
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forente stater, 15232
- University of Pittsburgh Medical Center
-
-
-
-
-
Bron, Frankrike, 69500
- Hopital Louis Pradel
-
Marseille, Frankrike, 13009
- INS Paoli-Calmettes
-
-
-
-
-
Aichi, Nagoya, Japan, 464-8681
- Aichi Cancer Center Hospital
-
Chiba, Kashiwa, Japan, 277-8577
- National Cancer Center Hospital East
-
Osaka, Osaka, Japan, 541-8567
- Osaka International Cancer Institute
-
Tokyo, Chuo-ku, Japan, 104-0045
- National Cancer Center Hospital
-
-
-
-
-
Groningen, Nederland, 9713 GZ
- Universitair Medisch Centrum Groningen
-
-
-
-
-
Barcelona, Spania, 08035
- Hospital Universitari Vall d'Hebron
-
Madrid, Spania, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, Spania, 28046
- Hospital Universitario La Paz
-
-
-
-
-
Gothenburg, Sverige, 413 46
- Sahlgrenska Universitetsjukhuset
-
Uppsala, Sverige, 751 85
- Uppsala University Hospital
-
-
-
-
-
München, Tyskland, 81377
- Klinikum der Universität München AÖR
-
Tübingen, Tyskland, 72076
- Universitätsklinikum Tübingen
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
-
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)
-
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses
-
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
-
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
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
-
Minimum life expectancy of 12 weeks
-
At least one measurable lesion as defined per RECIST 1.1 within approximately 35 days prior to the first dose of BI 764532
-
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Del B: BI 764532 + karboplatin + etoposid
|
BI 764532
Andre navn:
Standard of care Standard of care |
|
Eksperimentell: Del B: BI 764532 + cisplatin + etoposid
|
BI 764532
Andre navn:
Standard of care Standard of care |
|
Eksperimentell: Del A1: BI 764532 lav dose + karboplatin + etoposid
|
BI 764532
Andre navn:
Standard of care Standard of care |
|
Eksperimentell: Del A1: BI 764532 middels dose + karboplatin + etoposid
|
BI 764532
Andre navn:
Standard of care Standard of care |
|
Eksperimentell: Del A1: BI 764532 høy dose + karboplatin + etoposid
|
BI 764532
Andre navn:
Standard of care Standard of care |
|
Eksperimentell: Del A2: BI 764532 + karboplatin + etoposid
|
BI 764532
Andre navn:
Standard of care Standard of care |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Del B: Forekomst av dosebegrensende toksisiteter (DLT) i løpet av behandlingsperioden
Tidsramme: Inntil 36 måneder.
|
Inntil 36 måneder.
|
|
Del A1: Forekomst av doselimiterende toksisiteter (DLT) i vurderingsperioden for maksimal tolerert dose (MTD)
Tidsramme: Opptil 21 dager.
|
Opptil 21 dager.
|
|
Del A2: Redusert overvåking: forekomsten av DLT-er under behandlingsperioden
Tidsramme: Opptil 36 måneder.
|
Opptil 36 måneder.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Del A1: Forekomst av dosebegrensende toksisiteter (DLT) under behandlingsperioden
Tidsramme: Opptil 36 måneder.
|
Opptil 36 måneder.
|
|
|
Del A1: Forekomst av uønskede hendelser (AE) i løpet av behandlingsperioden
Tidsramme: Opptil 36 måneder.
|
Opptil 36 måneder.
|
|
|
Del A2: Forekomst av uønskede hendelser (UH) under behandlingsperioden
Tidsramme: Opptil 36 måneder.
|
Opptil 36 måneder.
|
|
|
Part B: 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.
|
|
Part B: Duration of response (DoR)
Tidsramme: Up to 36 months.
|
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.
|
|
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.
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Organiske kjemikalier
- Hydrokarboner
- Hydrokarboner, syklisk
- Karbohydrater
- Podofyllotoksin
- Tetrahydronaftalener
- Naftalener
- Polysykliske aromatiske hydrokarboner
- Hydrokarboner, aromatisk
- Polysykliske forbindelser
- Glukosider
- Glykosider
- Uorganiske kjemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinasjonskomplekser
- Platinumforbindelser
- Etoposid
- Karboplatin
- Cisplatin
Andre studie-ID-numre
- 1438-0007
- U1111-1292-1400 (Registeridentifikator: WHO Registry)
- 2023-505870-13-00 (Registeridentifikator: CTIS (EU))
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .