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Lurbinectedin for Ewing Sarcoma (LiFFT Trial)
LiFFT Trial Summary
This trial is testing if a drug called lurbinectedin is safe and effective at treating cancer, including Ewing sarcoma.
LiFFT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LiFFT Trial Design
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- My cancer has returned or didn't respond to initial treatment and has a specific genetic change.My kidney function, based on creatinine levels, is within the required range for my age and gender.I do not have any severe illnesses or infections that are not under control.I have a known bleeding disorder.My Ewing sarcoma has returned or didn't respond to first treatment, and tests confirm specific genetic changes.I am not currently taking any experimental drugs or cancer treatments.I am taking medication that strongly affects liver enzyme levels.I can care for myself and am up and about more than half of my waking hours.I can care for myself and am up more than half the day.I am taking supplements that can harm my liver.My liver, kidneys, bone marrow, and heart are functioning well.I do not have active hepatitis A, B, or C.I am 10 years old or older.My disease can be measured or evaluated by tests.My kidney function is within the required range for my age and gender.I have previously been treated with trabectedin or lurbinectedin.I have cancer that has spread to my brain.I am willing to have a tumor biopsy for the study.I have at least one tumor that can be measured or seen on scans and hasn't been treated with radiation.
- Group 1: Ewing Sarcoma
- 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
Is participation in this research study currently available?
"This research project is not currently seeking participants. After first appearing on clinicaltrials.gov in July 2023 and last being updated late June of the same year, this trial has since closed to candidates; however, 526 other trials are accepting enrollees at present."
What are the key goals of this clinical investigation?
"The prime aim of this trial, which will be evaluated within a period of four weeks from the first dose administration, is to assess Adverse Events Frequency. Additionally, Lurbinectedin Pharmacokinetics shall be measured through Area under the concentration-time curve (AUC). Secondary outcomes consist of Progression Free Survival (PFS) and Duration of Response (DoR), both assessed 6 months after commencement and determined by earliest date of death or disease progression respectively."
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