Brightline-1: A study to compare BI 907828 with doxorubicin in people with a type of cancer called dedifferentiated liposarcoma

JRCT ID: jRCT2061220016

Registered date:17/05/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: dedifferentiated liposarcoma
• Date of first enrollment: 03/08/2022
• Target sample size: 28
• Countries of recruitment: US,Japan,Australia,Japan,Belguim,Japan,Canada,Japan,China,Japan,Czech,Japan,Denmark,Japan,Finland,Japan,France,Japan,Greece,Japan,Germany,Japan,Hong Kong,Japan,Italy,Japan,Ireland,Japan,Netherlands,Japan,Norway,Japan,Portugal,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Turkey,Japan,UK,Japan
• Study type: Interventional

Intervention(s)

Different dose of BI 907828(30 mg or 45 mg) or 75 mg/m2
doxorubicin will be administrated once every 21 days.

Outcome(s)

• Primary Outcome: Progression-Free Survival

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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.
- 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.

Exclude criteria

- 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
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.

Related Information

• Primary Sponsor: Mori Hiroko
• Secondary ID(s): NCT05218499