Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma

Official Title

Brightline-1: A Phase II/III, Randomized, Open-label, Multi-centre Study of BI 907828 Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma

Summary:

This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate.

The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma.

During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment.

Participants can continue treatment in the study as long as they benefit from it and can tolerate it.

Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Trial Description

Primary Outcome:

• Progression-free survival

• Objective response (OR)
• Duration of objective response (DOR)
• Overall survival (OS)
• Disease control (DC)
• Change from baseline in QLQ-C30 (Quality of Life questionnaire C30)
• Change from baseline in EQ-5D5L (European Quality of Life 5 dimensions 5 level)
• Change from baseline in fatigue
• Change from baseline in pain
• Change from baseline in Patient Global Impression of severity (PGIS)
• Change from baseline in Patient Global Impression of Change (PGIC)

View this trial on ClinicalTrials.gov