2024-514177-21-00招募中2 期
A Phase II, single-arm, open-label, long-term safety rollover trial of oral brigimadlin in patients with solid tumours
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.27 个研究点 分布在 11 个国家目标入组 31 人开始时间: 2024年12月9日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 31
- 试验地点
- 27
- 主要终点
- Occurrence of treatment-emergent AEs according to CTCAE Version 5.0 during the entire treatment period
研究概览
简要总结
The primary objective of the trial is to evaluate the long-term safety and tolerability of brigimadlin monotherapy in a group of patients who have previously participated in another trial in the brigimadlin programme by assessing the incidence of treatment-emergent Adverse Events (AEs) and to characterise the severity, frequency, seriousness, relationship, and outcome of treatment emergent AEs.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient is ongoing on brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the ‘parent trial’).
- •Provision of signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
- •Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of <1% per year when used consistently and correctly beginning at Screening, during trial participation, and until 6 months and 12 days after the last dose for women and 102 days after the last dose for men. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information.
- •Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
- •Adequate organ function.
- •Patient is eligible to receive continued treatment according to the clinical trial protocol of the parent trial they are currently participating in. Patients currently experiencing a dose delay in the parent trial due to adverse events are eligible if recovery from the adverse event takes place within the allowed time window in the parent trial.
排除标准
- •Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin.
- •Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- •Patient unable to swallow the trial medication.
- •Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Female patients who do not agree to the interruption of breastfeeding from the start of study treatment until 6 months and 12 days after the last dose of study treatment.
- •Patient has unacceptable toxicity on brigimadlin at the time of transition into this trial.
- •Patient has an AE which has caused a dose delay and has not recovered within the allowed time window in the parent trial.
- •Patient who has already required 2 dose reductions and would require a third dose reduction at trial entry, unless the investigator deems treatment continuation beneficial, and the third dose reduction is agreed in writing between the investigator and the sponsor.
- •Further exclusion criteria apply.
研究组 & 干预措施
BI 907828, BI 907828, BI 907828
Test
干预措施: BI 907828 (Drug)
结局指标
主要结局
Occurrence of treatment-emergent AEs according to CTCAE Version 5.0 during the entire treatment period
Occurrence of treatment-emergent AEs according to CTCAE Version 5.0 during the entire treatment period
次要结局
未报告次要终点
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (27)
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