Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Recruiting now · Phase 1/Phase 2
Conditions studied: Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Ewing Sarcoma
In brief
This study is conducted in two phases. The phase 1 portion of the study evaluates the safety, tolerability, pharmacokinetics (PK), recommended phase 2 dose (RP2D), and effectiveness of lurbinectedin monotherapy in pediatric participants with previously treated solid tumors. This is followed by the phase 2 portion, to further assess the effectiveness and safety in pediatric and young adult participants with recurrent/refractory Ewing sarcoma.
Key facts
- Study ID
- NCT05734066
- Run by
- Jazz Pharmaceuticals
- People needed
- 60
- Starts
- 2023-05-23
- Expected to finish
- 2028-04-20
- Last updated by the study team
- 2026-02-03
Who can join
Age: 2 and older, up to 30. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
- Lucile Packard Children's Hospital — Palo Alto, California, United States (enrolling)
- Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (enrolling)
- Children's Healthcare of Atlanta at Arthur M. Blank Hospital — Atlanta, Georgia, United States (enrolling)
- Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
- Corewell Health — Grand Rapids, Michigan, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)
- Children's Health Dallas — Dallas, Texas, United States (enrolling)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- The Hospital for Sick Children — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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