Brightline-1: Advanced Dedifferentiated Liposarcoma

Treatment of BI 907828 Versus Doxorubicin in Patient With Advanced Dedifferentiated Liposarcoma (Brightline-1)

Agents: BI 907828 vs. Doxorubicin
Phase II/III
Status Recruiting
Sponsor Boehringer Ingelheim

 

For further information please also consult ClinicalTrials.gov.

 

This is a Phase II/III registration study evaluating the safety and efficacy of BI 907828 compared to doxorubicin in patients with advanced dedifferentiated liposarcoma.

 

WHO is the trial for?

  • Patients with advanced dedifferentiated liposarcoma
  • Patients must be 18 years or older
  • Overall health of the patient must be good (ECOG performance status of 0 or 1)
  • Pre-treated patients cannot participate

WHAT is the key question that this trial is attempting to answer?

This study aims to investigate a drug called BI 907828. The trial tries to find out whether BI 907828 or doxorubicin is more effective in patients with advanced dedifferentiated liposarcoma without previous therapy. In addition, safety and tolerability of the drug(s) is assessed.

WHY patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease. The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

This study is open for recruitment.

WHERE is the trial available?

The trial is being conducted in several study centers in the US, Australia, Belgium, Canada, China, Czechia, Denmark, Finland, France, Germany, Greece, Hongkong, Ireland, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Taiwan, Turkey, UK. For further information please check here.
Study contact: Boehringer Ingelheim (US): 1-800-243-0127 or clintriage.rdg@boehringer-ingelheim.com

STUDY DESIGN: What does the study look like?

This study has two phases. Depending on when you enter the trial you will be placed in phase 2 or phase 3. Participants in phase 2 will be randomized (assigned by random choice) after screening to receive the trial drug, BI 907828 or doxorubicin.

Participants in phase 3 will be randomized to receive the dose of BI 907828 which has been determined to be the most safe and effective during phase 2 of the trial or will receive doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein.

Those patients who received doxorubicin in the first part of the trial and whose disease has progressed may cross-over later in the trial to receive the trial drug.

Treatment will continue unless a patient’s disease worsens, there are unacceptable adverse events (side effects), or a patient decides to leave the trial. A safety follow-up period follows the treatment period.

HOW do I get more information?

Patient organizations supporting sarcoma and/or GIST patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations serving GIST and/or sarcoma patients. If there are no such organization in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

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