2024-511361-11-00招募中3 期
Brightline-1: A Phase II/III, randomized, open-label, multi-center study of brigimadlin (BI 907828) compared to doxorubicin as first line treatment of patients with advanced dedifferentiated liposarcoma
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.49 个研究点 分布在 12 个国家目标入组 209 人开始时间: 2024年9月5日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 209
- 试验地点
- 49
- 主要终点
- Progression-free survival (PFS). PFS based on central independent review will be assessed at the interim futility analysis at approximately the same time as the end of Phase II, and the primary PFS analysis will take place during the Phase III part.
研究概览
简要总结
The primary objective of the trial is to evaluate whether brigimadlin is superior to doxorubicin as first line systemic therapy for advanced or metastatic DDLPS.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated, written informed consent form ICF in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
- •Male or female patients ≥18 years old at the time of signature of the ICF. 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 less than 1% per year when used consistently and correctly beginning at screening, during trial participation, and until 6 months and 12 days after last dose. A list of contraception methods meeting these criteria is provided in the patient information.
- •Histologically proven locally advanced or metastatic, unresectable (surgery morbidity would outweigh potential benefits), progressive or recurrent DDLPS. Locally performed histopathological diagnosis will be accepted for entry into this trial but will be confirmed by independent pathological review while the patients receive treatment in this trial.
- •Written pathology report indicating the diagnosis of DDLPS with positive MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization or NGS must be available.
- •Formalin fixed paraffin embedded tumor blocks or slides must be available for retrospective histopathological central review.
- •Presence of at least one measurable target lesion according to RECIST version 1.
- •In patients who only have one target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or
- •Patient must be willing to donate blood samples for the pharmacokinetics, pharmacodynamics, and tumor mutation analysis.
- •Further inclusion criteria apply.
排除标准
- •Known mutation in the TP53 gene (screening for TP53 status is not required).
- •Major surgery (major according to the investigator’s assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening.
- •Prior systemic therapy for liposarcoma in any setting (including adjuvant, neoadjuvant, maintenance, palliative).
- •Previous or concomitant malignancies other than DDLPS or WDLPS, treated within the previous 5 years, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, or other malignancy that is considered cured by local treatment.
- •Previous treatment with anthracyclines in any setting (systemic treatment with other anticancer agents is allowed if completed at least 5 years prior to study entry with the exception of hormone therapy).
- •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.
- •Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s).
- •Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator’s opinion, makes the patient an unreliable trial participant).
- •Further exclusion criteria apply.
结局指标
主要结局
Progression-free survival (PFS). PFS based on central independent review will be assessed at the interim futility analysis at approximately the same time as the end of Phase II, and the primary PFS analysis will take place during the Phase III part.
Progression-free survival (PFS). PFS based on central independent review will be assessed at the interim futility analysis at approximately the same time as the end of Phase II, and the primary PFS analysis will take place during the Phase III part.
次要结局
- Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 (based on blinded central independent review) from the date of randomization until disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, withdrawal of consent, or end of patient's participation in the trial, whichever occurs first.
- Duration of objective response (DOR), defined as the time interval from first documented confirmed OR until disease progression or death among patients with confirmed objective response (based on blinded central independent review), whichever occurs first.
- Overall survival (OS) will be assessed at the end of the Phase III part of the trial. OS is defined as the time interval from randomization until death from any cause.
- Disease control (DC), defined as a best overall response of CR, PR, or stable disease (SD) according to RECIST version 1.1 (based on blinded central independent review).
- Health-Related Quality of Life (HRQoL), based on data collected through specific questionnaires (Patient Reported Outcome Measures, PROMs), analyzed from baseline to Week 6 and to Week 18. The HRQoL endpoints are defined as the scores calculated from data collected through selected EORTC QLQ-C30 domains (physical functioning, pain, fatigue, and global health status / quality of life), fatigue and pain based on items from the EORTC QLQ-C30 and the EORTC Item Library, and the EQ-5D5L.
- Occurrence of treatment-emergent adverse events (AEs).
- Occurrence of treatment-emergent AEs leading to study drug discontinuation.
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (49)
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