RecruitingPhase 1Phase 2NCT05734066

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

A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma.


Sponsor

Jazz Pharmaceuticals

Enrollment

60 participants

Start Date

May 23, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a drug called lurbinectedin in children, teenagers, and young adults with Ewing sarcoma — a type of bone and soft tissue cancer — that has come back or stopped responding to treatment. The study first determines the right dose (Phase 1), then assesses how well the drug works (Phase 2). **You may be eligible if...** - You are between 2 and 30 years old (age range depends on which part of the study) - You have a confirmed Ewing sarcoma diagnosis that has relapsed or is treatment-resistant - You are in adequate health overall (Lansky/Karnofsky performance status ≥ 50%) - You have adequate liver, kidney, bone marrow, and heart function - You weigh at least 15 kg - You have not previously received lurbinectedin or a related drug (trabectedin) **You may NOT be eligible if...** - You have active brain or spinal cord metastases requiring steroids - You have an abnormal heart rhythm that prolongs the QT interval on an ECG - You have an active, uncontrolled infection - You have had a bone marrow or organ transplant from a donor - You are pregnant or breastfeeding - You have had chemotherapy within the past 3 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLurbinectedin

Administered as intravenous (IV) infusion once every 3 weeks (Q3W)


Locations(15)

Children's Hospital of Los Angeles

Los Angeles, California, United States

Lucile Packard Children's Hospital

Palo Alto, California, United States

Children's National Hospital

Washington D.C., District of Columbia, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Children's Healthcare of Atlanta at Arthur M. Blank Hospital

Atlanta, Georgia, United States

Johns Hopkins University

Baltimore, Maryland, United States

Corewell Health

Grand Rapids, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Children's Health Dallas

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

The Hospital for Sick Children

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05734066


Related Trials