Brightline-1: A Phase II/III, randomized, open-label, multi-center study of BI 907828 compared to doxorubicin as first line treatment of patients with advanced dedifferentiated liposarcoma

Mori Hiroko0 个研究点目标入组 28 人开始时间: 2022年5月17日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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
•- 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.
•- Male or female patients >=18 years old.
•- 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 1.1.
•- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•- Patient willing to donate blood samples for the pharmacokinetics, pharmacodynamics, and tumor mutation analysis.
•- Patient willing to undergo a mandatory tumor biopsy.
•- Adequate organ function as defined by inclusion criteria detailed in the clinical trial protocol.

•- Known mutation in the TP53 gene (screening for TP53 status is not required).
•- Major surgery (major according to the investigators 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, and prostate cancer.
•- Previous treatment with anthracyclines in any setting (systemic treatment with other anti-cancer agents is allowed if completed at least 5 years prior to study entry with the exception of hormone
•- 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.

发起方

Mori Hiroko