Lurbinectedin for FET-Fused Tumors
This study is testing a drug called lurbinectedin to see if it is safe and effective for people with certain types of recurrent (cancer that has come back) or relapsed (cancer that has returned after treatment) solid tumors. This includes Ewing sarcoma, a type of cancer that affects bones and soft tissues. You may be able to join if you are 10 years or older and have a solid tumor that has a specific genetic change called a FET fusion. Researchers will look at side effects (adverse events) and how well the treatment shrinks or gets rid of the tumor (complete or partial response). The study plans to enroll 63 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 63 participants.
- What's involved
- Lurbinectedin will be given on Day 1 and Day 4 every 21 days. The exact duration of treatment and number of visits are not specified.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor for side effects for 28 days after the last dose. Tumor responses will be measured through the end of treatment, an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Lurbinectedin in FET-Fused Tumors
At a glance
Conditions
Where it's being run
6 sites across 6 statesStudy leadership
- Theodore Laetsch, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
Who to contact
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What this trial measures
- Phase 1: Dose Limiting Toxicities (DLTs)within 28 days of the first dose
First cycle (approximately 21 days) Dose Limiting Toxicities (DLTs) will be evaluated.
- Phase 1: Frequency of adverse events28 days after last dose
Adverse events to be reported during treatment and for at least 28 days after last dose.
- Phase 1: Complete Response or Partial Responsethrough the end of treatment, an average of 1 year
Percentage of participants with complete response or partial response will be assessed approximately every 2 to 4 cycles through the end of treatment and up to at least 28 days after the last dose.
- Phase 2: Event-Free Survival (EFS)2 years
Event-free survival (EFS) is based on investigator assessment from baseline until Month 24.