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JOURNAL ONKOLOGIE – STUDIE

DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers

Rekrutierend

NCT-Nummer:
NCT06132113

Studienbeginn:
Dezember 2023

Letztes Update:
01.05.2024

Wirkstoff:
BI 764532, Carboplatin, Etoposide, Cisplatin

Indikation (Clinical Trials):
Neuroendocrine Tumors

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Boehringer Ingelheim

Collaborator:
-

Kontakt

Studienlocations
(3 von 9)

Viszeralonkologisches Zentrum Universitätsklinikum Tübingen
Hoppe-Seyler-Straße 3
72076 Tübingen
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

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 2 parts. Part A of this study aims to find out the highest dose of BI 764532

that people can tolerate in addition to 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.

Ein-/Ausschlusskriterien

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 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 1 week 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), except for appropriately

treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix

Further exclusion criteria apply.

Studien-Rationale

Primary outcome:

1. Part A: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period (Time Frame - Up to 21 days.)

2. Part B: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period (Time Frame - Up to 36 months.)

Secondary outcome:

1. Part A: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period (Time Frame - Up to 36 months.)

2. Part A: Occurrence of adverse events (AEs) during the on-treatment period (Time Frame - Up to 36 months.)

3. Part B: Objective response (OR) (Time Frame - 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.

4. Part B: Duration of response (DoR) (Time Frame - Up to 36 months.):
Duration of response (DoR), 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.

Studien-Arme

  • Experimental: Part A: BI 764532 low dose + carboplatin + etoposide
  • Experimental: Part A: BI 764532 medium dose + carboplatin + etoposide
  • Experimental: Part A: BI 764532 high dose + carboplatin + etoposide
  • Experimental: Part B: BI 764532 + carboplatin + etoposide
  • Experimental: Part B: BI 764532 + cisplatin + etoposide

Geprüfte Regime

  • BI 764532:
    BI 764532
  • Carboplatin:
    Standard of care
  • Etoposide:
    Standard of care
  • Cisplatin:
    Standard of care

Quelle: ClinicalTrials.gov


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