Actively Recruiting
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Led by Jazz Pharmaceuticals · Updated on 2026-02-03
60
Participants Needed
15
Research Sites
256 weeks
Total Duration
On this page
Sponsors
J
Jazz Pharmaceuticals
Lead Sponsor
J
Jazz Pharmaceuticals Ireland Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be between 2 and less than 18 years old for Phase 1 Part 1, or between 2 and 30 years old for Phase 1 Part 2 and Phase 2.
- Participants must have a confirmed solid tumor.
- Participants must have a Lansky/Karnofsky performance status score of 50% or higher.
- Participants must have adequate liver function: AST and ALT less than or equal to 2.5 times the upper limit of normal; total bilirubin less than or equal to 1.5 times institutional upper limit of normal (or less than 3 times for Gilbert's syndrome).
- Participants must have adequate bone marrow function: ANC greater than or equal to 1.0 x 10^9/L, platelets greater than or equal to 100 x 10^9/L, hemoglobin greater than or equal to 8 g/dL.
- Participants must have adequate renal function with creatinine clearance greater than or equal to 60 mL/min.
- Participants must have adequate cardiac function with ejection fraction or shortening fraction at or above institutional lower limit of normal.
- Participants must have creatine phosphokinase less than or equal to 2.5 times institutional upper limit of normal.
- Participants must weigh at least 15 kg.
- Male participants must agree to refrain from donating sperm and either remain abstinent or use specified contraception methods during the study and for at least 4 months after.
- Female participants must not be pregnant or breastfeeding and either be of non-childbearing potential or use acceptable contraception during the study and for at least 7 months after.
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before first dose.
- Participants must be capable of giving signed informed consent and comply with study requirements.
You will not qualify if you...
- Participants with prolonged corrected QT interval (QTc ≥ 460 ms if under 18 years old, or QTc ≥ 470 ms if 18 years or older).
- Participants with symptomatic central nervous system metastases requiring steroids, unless treated, recovered, off high-dose steroids for at least 2 weeks, and neurologically stable.
- Participants with persisting toxicity from prior therapy, except for certain mild adverse events.
- Participants with uncontrolled illness including active infections requiring treatment, symptomatic heart failure, cardiac arrhythmia, or psychiatric/social issues limiting compliance.
- Participants with other major illnesses that increase risk per investigator judgment.
- Participants with diseases or conditions that contraindicate investigational drug use or interfere with results.
- Participants who received prior lurbinectedin or trabectedin treatment.
- Participants who received investigational products within 4 weeks prior to study intervention.
- Participants who received live vaccines within 4 weeks prior to study or plan to receive during study.
- Participants who had major surgery within 4 weeks or radiation therapy within 2 weeks prior to enrollment unless fully recovered.
- Participants who had prior allogeneic bone marrow or solid organ transplantation.
- Participants who received chemotherapy within 3 weeks prior to study intervention.
- Participants with hepatitis B or C infection or HIV infection at screening.
- Participants with known or suspected hypersensitivity to study drug components.
- Participants or guardians unable to comply with study visit schedule and requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
Actively Recruiting
3
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
5
Children's Healthcare of Atlanta at Arthur M. Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
6
Johns Hopkins University
Baltimore, Maryland, United States, 21238
Actively Recruiting
7
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
10
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
11
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
13
Children's Health Dallas
Dallas, Texas, United States, 75235
Actively Recruiting
14
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
15
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
Research Team
C
Clinical Trial Disclosure & Transparency
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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