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NCT05734066 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Ewing Sarcoma and Refractory Ewing Sarcoma, sponsored by Jazz Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
60
Enrollment target
15
Study locations

NCT05734066 is a Phase 1 study of Ewing Sarcoma and Refractory Ewing Sarcoma that is actively recruiting participants, run by Jazz Pharmaceuticals. The registered enrollment target is 60 participants, below the 107-participant average among 26 other Ewing Sarcoma trials with a reported enrollment target (44% lower). The trial reports 15 study locations across 12 states.

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The verdict

NCT05734066, a Phase 1 study of Ewing Sarcoma and Refractory Ewing Sarcoma, is actively recruiting participants, sponsored by Jazz Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
15
Study locations

Study 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.

Conditions Studied

Ewing Sarcoma Refractory Ewing Sarcoma Relapsed Ewing Sarcoma

Interventions

  • DRUG Lurbinectedin

Study Locations (15)

California

  • Children's Hospital of Los Angeles - Los Angeles
  • Lucile Packard Children's Hospital - Palo Alto

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati
  • Nationwide Children's Hospital - Columbus

Texas

  • Children's Health Dallas - Dallas
  • The University of Texas MD Anderson Cancer Center - Houston

District of Columbia

  • Children's National Hospital - Washington D.C.

Florida

  • Johns Hopkins All Children's Hospital - St. Petersburg

Georgia

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

Maryland

  • Johns Hopkins University - Baltimore

Michigan

  • Corewell Health - Grand Rapids

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2023-05-23
Est. Completion 2028-04-20
Phase Phase 1

Sponsor

Jazz Pharmaceuticals

128 total trials

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What the Registry Record Tells You About NCT05734066

The ClinicalTrials.gov registry entry for NCT05734066 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 107-participant average among 26 other Ewing Sarcoma trials with a reported enrollment target (44% lower). The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Ewing Sarcoma appearing as the primary indexed condition, and to 1 intervention - of which Lurbinectedin is the first listed.

NCT05734066 reports 15 study locations spanning 12 distinct geographic areas - top geographies include California, Ohio, Texas.

Frequently Asked Questions

What is clinical trial NCT05734066 about?

NCT05734066 is a clinical study titled "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 p...

What is the current status of trial NCT05734066?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-05-23. Estimated completion is 2028-04-20.

What conditions does trial NCT05734066 study?

This clinical trial studies the following conditions: Ewing Sarcoma, Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma.

What interventions are being tested in trial NCT05734066?

The interventions under investigation include: Lurbinectedin (DRUG).

Who is sponsoring clinical trial NCT05734066?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05734066 being conducted?

This trial has 15 study locations across California, District of Columbia, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.