DAREON™-7: 進行神経内分泌がん患者が化学療法に加えて異なる用量の BI 764532 をどの程度忍容できるかを試験する研究
DAREON™-7: 神経内分泌がん患者の第一選択治療における標準治療 (プラチナおよびエトポシド) と併用した BI 764532 静脈内注入の安全性と忍容性を調査するための第 I 相非盲検用量漸増および拡張試験 ( 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.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Florida
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Miami、Florida、アメリカ、33136
- University of Miami
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Winship Cancer Institute
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University
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New Jersey
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Hackensack、New Jersey、アメリカ、07601
- John Theurer Cancer Center
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15232
- University of Pittsburgh Medical Center
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Groningen、オランダ、9713 GZ
- Universitair Medisch Centrum Groningen
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Gothenburg、スウェーデン、413 46
- Sahlgrenska Universitetsjukhuset
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Uppsala、スウェーデン、751 85
- Uppsala University Hospital
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Barcelona、スペイン、08035
- Hospital Universitari Vall d'Hebron
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Madrid、スペイン、28041
- Hospital Universitario 12 de Octubre
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Madrid、スペイン、28046
- Hospital Universitario La Paz
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München、ドイツ、81377
- Klinikum der Universität München AÖR
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Tübingen、ドイツ、72076
- Universitätsklinikum Tübingen
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Bron、フランス、69500
- Hopital Louis Pradel
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Marseille、フランス、13009
- INS Paoli-Calmettes
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Brussels、ベルギー、1200
- Cliniques Universitaires Saint-Luc
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Edegem、ベルギー、2650
- Universitair Ziekenhuis Antwerpen
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Aichi, Nagoya、日本、464-8681
- Aichi Cancer Center Hospital
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Chiba, Kashiwa、日本、277-8577
- National Cancer Center Hospital East
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Osaka, Osaka、日本、541-8567
- Osaka International Cancer Institute
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Tokyo, Chuo-ku、日本、104-0045
- National Cancer Center Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：パート B: BI 764532 + カルボプラチン + エトポシド
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BI 764532
他の名前：
Standard of care Standard of care |
|
実験的：パート B: BI 764532 + シスプラチン + エトポシド
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BI 764532
他の名前：
Standard of care Standard of care |
|
実験的：パートA1：BI 764532 低用量 + カルボプラチン + エトポシド
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BI 764532
他の名前：
Standard of care Standard of care |
|
実験的：パートA1：BI 764532中用量＋カルボプラチン＋エトポシド
|
BI 764532
他の名前：
Standard of care Standard of care |
|
実験的：パートA1：BI 764532高用量 + カルボプラチン + エトポシド
|
BI 764532
他の名前：
Standard of care Standard of care |
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実験的：Part A2: BI 764532 + カルボプラチン + エトポシド
|
BI 764532
他の名前：
Standard of care Standard of care |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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パート B: 治療期間中の用量制限毒性 (DLT) の発生
時間枠：最長36か月。
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最長36か月。
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パートA1：最大耐用量（MTD）評価期間中の用量制限毒性（DLT）の発生
時間枠：最大21日間。
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最大21日間。
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パートA2：低頻度モニタリング：治療期間中のDLT発生
時間枠：最大36か月。
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最大36か月。
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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パートA1：治療期間中の用量制限毒性（DLT）の発生
時間枠：最大36か月。
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最大36か月。
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パートA1：治療期間中の有害事象（AE）の発生
時間枠：最大36か月。
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最大36か月。
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パートA2：治療期間中の有害事象（AEs）の発生
時間枠：最大36ヶ月間。
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最大36ヶ月間。
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Part B: Objective response (OR)
時間枠：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.
|
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Part B: Duration of response (DoR)
時間枠：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)
時間枠：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.
|
協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1438-0007
- U1111-1292-1400 (レジストリ識別子：WHO Registry)
- 2023-505870-13-00 (レジストリ識別子：CTIS (EU))
- 2023 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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