رادار التجارب السريرية

Name: Beamion PANTUMOR-1: A Phase II, Multicentre, Multicohort, Open-label Trial to Evaluate the Efficacy and Safety of Oral Zongertinib (BI 1810631) for the Treatment of Selected HER2-mutated or Overexpressed/Amplified Solid Tumours
Creator: Boehringer Ingelheim
Published: 2024-09-03
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

بيتا

رادار التجارب AI مرشح للتجارب أو مريض مقدم رعاية المريض محترف الرعاية الصحية محترف التكنولوجيا الحيوية مستثمر في التكنولوجيا الحيوية باحث أخرى
	حالة التجربة السريرية NCT06581432 لـ أورام صلبة هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.

تجربة واحدة تطابق معايير الفلتر

عرض البطاقة

Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations المرحلة الثانية ٤٣٠

يقبل مشاركين

تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.

التجربة السريرية NCT06581432 مصممة لدراسة علاج لـأورام صلبة. إنها تجربة تدخُّلية من المرحلة الثانية وهي يقبل مشاركين. بدأت في ٨ ربيع الآخر ١٤٤٦ هـ مع خطة لتجنيد ٤٣٠ مشاركًا. تقودها Boehringer Ingelheim، ومن المتوقع اكتمالها بحلول ١٣ شعبان ١٤٥٠ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٨ رمضان ١٤٤٧ هـ.

الملخص

This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2.

Participants are put into 13 groups b...

عرض المزيد

العنوان الرسمي

Beamion PANTUMOR-1: A Phase II, Multicentre, Multicohort, Open-label Trial to Evaluate the Efficacy and Safety of Oral Zongertinib (BI 1810631) for the Treatment of Selected HER2-mutated or Overexpressed/Amplified Solid Tumours

الحالات الطبية

أورام صلبة

المنشورات

Schram AM, Park JJ, Italiano A, Kitano S, Guo Y, Li J, Bedard PL, van Marcke C, Ko R, Lunger L, Klotz DM, Hussain J, Maier D, Erzen D, Planchard D, Prenen H, Clay TD, Park JO, Kim HD, Hernando-Calvo A, Maruki Y, Ponz-Sarvise M, Dumbrava E. Beamion PANTUMOR-1: rationale and design of a Phase II...

عرض المزيد

معرّفات دراسة أخرى

1479-0009
2023-510429-14-00 (معرف السجل) (CTIS)
U1111-1302-3333 (معرف السجل) (WHO International Clinical Trials Registry Platform (ICTRP))

NCT معرّف

NCT06581432

تاريخ البدء (فعلي)

2024-10-11

آخر تحديث مُنشور

2026-03-17

تاريخ الاكتمال (المقدر)

2028-12-29

عدد المشاركين المخطط لهم

٤٣٠

نوع الدراسة

تدخُّلية

المرحلة

المرحلة الثانية

الحالة

يقبل مشاركين

الغرض الأساسي

العلاج

طريقة توزيع المشاركين

غ/م

نموذج التدخل

المجموعة الواحدة

التعمية

لا شيء (تجربة مفتوحة)

مجموعات/التدخلات

مجموعة المشاركين/الذراع	التدخل/العلاج
تجريبيةZongertinib treatment	Zongertinib Zongertinib

ما الذي تقيسه الدراسة؟

النتيجة الرئيسية

مقياس النتيجة	وصف القياس	الإطار الزمني
Proportion of patients with objective response (OR)	Objective response (OR) is defined as the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as assessed by central independent review, from the date of treatment start until the earliest date of progressive disease (PD), death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or trial treatment discontinuation.	Up to 51 months

النتيجة الثانوية

مقياس النتيجة	وصف القياس	الإطار الزمني
Duration of objective response (DOR)	Duration of objective response (DOR) is defined as the time from first documented Objective response (OR) according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed OR, assessed by central independent review.	Up to 51 months
Progression-Free Survival (PFS)	PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST 1.1 assessed by central independent review, or death from any cause, whichever occurs first.	Up to 51 months
Disease control (DC)	Disease control (DC) is defined as best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) where BOR is defined according to RECIST 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or treatment discontinuation, as assessed by central independent review.	Up to 51 months
Occurrence of treatment-emergent Adverse Events (AEs)		Up to 51 months
Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, in the European Organisation for Research and Treatment of Cancer, quality-of-life questionnaire (EORTC QLQ-C30)	QLQ-C30 incorporates both multi-items scales and single-item measures. These include 1 global health status/QoL scale, 5 functional scales, 3 symptoms scales and 6 single items to assess dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. EORTC QLQ-C30 does not produce a single overall summary score by default. Scores can be reported via domain-specific scores or summary score (since 2016) ranging from 0 to 100 with higher scores representing a better QoL.	At baseline and up to 48 weeks
Overall survival (OS)	OR is defined as the time from start of treatment to death from any cause	Up to 51 months

مساعد المشاركة

معايير الأهلية

الأعمار المؤهلة للدراسة

بالغ, كبار السن

العمر الأدنى للدراسة

18 Years

الجنس المؤهل

الكل

Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Patients ≥18 years old or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the Informed consent form (ICF).
Documented (previously established by local testing) Human epidermal growth factor receptor 2 (HER2) status of:
- HER2 overexpression/amplification
- Known activating HER2 mutations
Availability and willingness to provide a sample of archival formalin-fixed paraffin embedded (FFPE) tumour tissue material
Patient with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumour who has had at least one prior line of therapy for metastatic disease. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival.

Further inclusion criteria apply.

Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC) (except where there is co-existing presence of HER2 overexpression / amplification)
Previous or concomitant malignancies other than the 1 treated in this trial within the previous 3 years except:
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ of the breast
- localised prostate cancer on watchful waiting or active surveillance
- other effectively treated malignancy that is considered cured by local treatment.
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Not completely recovered from major surgery (major according to the investigator's assessment) performed prior to screening or planned within 6 months after screening, e.g. hip replacement Further exclusion criteria apply.

Boehringer Ingelheim

جهة اتصال مركزية للدراسة

جهة اتصال: Boehringer Ingelheim, 1-800-243-0127, [email protected]

82 مواقع الدراسة في 16 بلدان

الولايات المتحدة

Alaska

Alaska Oncology and Hematology, LLC, Anchorage, Alaska, 99508, United States