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BI 907828 vs Doxorubicin for Liposarcoma
Study Summary
This trial is comparing two treatments for dedifferentiated liposarcoma- BI 907828 and doxorubicin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am over 18, can follow birth control guidelines if needed, and agree to the consent form.I have received treatment for liposarcoma before.I have had cancer other than DDLPS or WDLPS in the last 5 years, but it was treated and considered cured.I have a tumor that can be measured by scans.I have been treated with anthracyclines before, but any other cancer treatment was over 5 years ago, except hormone therapy.My pathology report shows a DDLPS diagnosis with positive MDM2.My organs are working well.My cancer samples are stored and available for review.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is a type of advanced liposarcoma that cannot be removed by surgery.I have signed and understand the consent form for this trial.I have a known TP53 gene mutation.I haven't had major surgery in the last 4 weeks and don't plan any in the next 6 months.I am not taking any medication that could interfere with the trial's safety.I am willing to have a tumor biopsy as required.I am willing to give blood samples for research on my cancer treatment.
- Group 1: Brigimadlin (BI 907828) high dose
- Group 2: Brigimadlin (BI 907828) arm
- Group 3: Brigimadlin (BI 907828) low dose
- Group 4: Doxorubicin arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
In how many different medical research facilities is this experiment being conducted today?
"38 hospitals and clinics are currently running this study. If you choose to participate in the trial, it is important to select a location near to reduce the travel burden."
Are investigators currently looking for more participants?
"From what is displayed on clinicaltrials.gov, it appears as though this trial is still looking for volunteers. The listing was published on March 25th, 2022 and the most recent update was November 2nd of the same year."
How many willing participants are needed for this clinical trial?
"In order to properly run this trial, 300 individuals that meet the necessary requirements must be recruited. The sponsor company, Boehringer Ingelheim, will manage the study from various hospitals including Oregon Health and Sciences University in Portland, Oregon as well as The Ottawa Hospital located in Ottawa, Ontario."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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