jRCT2031220405进行中（未招募）不适用
Brightline-2: A Phase IIa/IIb, open-label, single-arm, multi-centre trial of BI 907828 for treatment of patients with locally advanced / metastatic, MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, or other selected solid tumours (Brightline-2)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 主要终点
- Objective response (OR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Diagnosis of a solid tumour which meets the criteria for an open trial cohort:
- •Cohort 1 (biliary tract adenocarcinoma):
- •Locally advanced or metastatic biliary tract adenocarcinoma (intra- and extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary cancer). Patient must have received appropriate prior standard of care therapy; or (in the opinion of the investigator) patient is unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
- •Cohort 2-4 (pancreatic ductal adenocarcinoma, lung adenocarcinoma, urothelial bladder cancer):
- •Locally advanced or metastatic pancreatic ductal adenocarcinoma/lung adenocarcinoma/urothelial bladder
- •cancer. Patient must have received appropriate prior standard of care therapy.
- •Written pathology report / molecular profiling report indicating MDM2 amplification (copy number >=8) and TLocally advanced or metastatic pancreatic ductal adenocarcinoma. Patient must have received appropriate prior standard of care therapy.
- •P53 wild-type status.
- •Archival tissue (formalin fixed paraffin embedded [FFPE] tumour blocks or slides) or a fresh tumour biopsy must be provided for retrospective confirmation of MDM2 amplification and TP53 status.
- •Presence of at least 1 measurable target lesion according to RECIST version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or
- •Adequate organ function.
排除标准
- •Previous administration of BI 907828 or any other MDM2-p53 or MDMX (MDM4)-p53 antagonist.
- •Active bleeding, significant risk of haemorrhage (e.g. previous severe gastrointestinal bleeding, previous haemorrhagic stroke at any time), or current bleeding disorder (e.g. haemophilia, von Willebrand disease).
- •Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of trial treatment or planned within 6 months after screening (e.g. hip replacement).
- •Clinically significant previous or concomitant malignancies in the opinion of the investigator affecting the efficacy and/or outcome of the trial.
- •Patients who must or intend to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- •Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or efficacy endpoint assessment.
结局指标
主要结局
Objective response (OR)
时间窗: 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
OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1
次要结局
- DOR
- PFS
- OS
- Disease control (DC)
- Occurrence of treatment-emergent adverse events (AEs)(on-treatment period)
- Occurrence of treatment-emergent AEs leading to trial drug discontinuation(on-treatment period)
- Change from baseline in EORTC QLQ-C30 physical functioning domain score
- Change from baseline in EORTC QLQ-C30 fatigue domain score
- Change from baseline in EORTC QLQ-C30 role functioning domain score
- Change from baseline in EORTC QLQ-BIL21 tiredness domain score
研究者
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