Clinical Trial

Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma

Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2023-02-15; most recent amendment 2026-01-30.
Status change: Not Yet Recruiting → Recruiting 2023-03-09
Trial Details
NCT Number NCT05734066
Lead Sponsor Jazz Pharmaceuticals
Collaborators: Jazz Pharmaceuticals Ireland Limited
Conditions Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Ewing Sarcoma
Enrollment 60 participants
Start Date 2023-05-23
Primary Completion 2028-01-28 (estimated)
Study Completion 2028-04-20 (estimated)
Updated on ClinicalTrials.gov 2026-02-03