Status: Recruiting
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
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.
Participants needed: 60
Trial details
Phase: Phase 1, Phase 2Age: 2-30Biological sex: AllType: InterventionalSponsor: Jazz PharmaceuticalsUpdated: Feb 3, 2026Locations: 15
Eligibility criteria
Phase 1 Part 1: participants must be ≥ 2 to < 18 years of age. [+24]
corrected QT interval (QTc) prolongation defined as a QTc ≥ 460 ms using the Baz... [+15]