EMERGE 101: Lurbinectedin in Ewing Sarcoma (kids & young adults)

 

Trial name: EMERGE 101: Lurbinectedin in Ewing's Sarcoma
Agents: Lurbinectedin
Phase I/II
Status Recruiting
Sponsor Jazz Pharmaceuticals

 

This phase I/II study evaluates the safety, efficacy, and optimal dosing of lurbinectedin in pediatric and young adult patients with previously treated recurrent or refractory Ewing sarcoma.

Further information can be found on clinicaltrials.gov.

 

WHO is the trial for?
  • Phase 1 of the study: Pediatric participants with previously treated solid tumors: ≥ 2 to ≤ 30 years of age for Ewing sarcoma patients
  • Phase 2 of the study (expansion): Pediatric and young adult patients with relapsed/refractory Ewing sarcomas: ≥ 2 to ≤ 30 years

Excluded are patients with prior treatment with lurbinectedin or trabectedin

WHAT is the key question that this trial is attempting to answer?

 This study assesses the safety, efficacy, and optimal dosing of lurbinectedin in pediatric and young adult patients with advanced Ewing sarcoma.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 The study is open for recruitment.

WHERE is the trial available?

 The trial is currently active in the US and Canada.

Please check for current information here.

STUDY DESIGN: What does the study look like?

 This study is a two-phase clinical trial:

  • Phase 1 focuses on evaluating the safety, tolerability, pharmacokinetics (PK), recommended phase 2 dose, and preliminary effectiveness of lurbinectedin monotherapy in pediatric patients with previously treated solid tumors incl. Ewing sarcomas.
  • Phase 2 further investigates the effectiveness and safety of lurbinectedin in pediatric and young adult patients with recurrent or refractory Ewing sarcoma.

HOW do I get more information?

 Patient organizations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations serving GIST and/or sarcoma patients. If there are no such organization in your country, please email us for more information: info@sarcoma-patients.org

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken