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.

Trial Details

NCT ID
NCT05734066
Phase
PHASE1 / PHASE2
Sponsor
Jazz Pharmaceuticals
Status
RECRUITING
Cancer Type
Osteosarcoma Sarcoma
Interventions
  • Lurbinectedin
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Palo Alto, California, United States|37.44188,-122.14302
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • St. Petersburg, Florida, United States|27.77086,-82.67927
  • Atlanta, Georgia, United States|33.749,-84.38798

Key Eligibility Criteria

  • Participant must meet the following age requirements at the time the informed consent form (ICF) (and assent form, if applicable) is signed:
  • Phase 1 Part 1: participants must be ≥ 2 to \< 18 years of age.
  • Phase 1 Part 2: participants must be ≥ 2 to ≤ 30 years of age.
  • Phase 2: participants must be ≥ 2 to ≤ 30 years of age.

For full eligibility, visit ClinicalTrials.gov.

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