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Alkylating agent

Lurbinectedin for Ewing Sarcoma (EMERGE 101 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must have a confirmed solid tumor
Participant must have a Lansky/Karnofsky performance status score of ≥ 50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: predose up to approximately 168 hours postdose; days 16, 31, 46: predose up to approximately 5 minutes postdose.
Awards & highlights

EMERGE 101 Trial Summary

This trial studies lurbinectedin to treat pediatric/young adult cancer patients with recurrent/refractory Ewing sarcoma. It evaluates safety, effectiveness, and dose.

Who is the study for?
This trial is for young individuals aged 2 to 30 with relapsed/refractory Ewing Sarcoma. They must have a solid tumor diagnosis, acceptable organ function, and performance status. Participants need adequate bone marrow, liver, kidney, and heart functions and weigh over 15 kg. Males must agree to contraception rules; females cannot be pregnant or breastfeeding and must use contraception.Check my eligibility
What is being tested?
The study tests Lurbinectedin monotherapy in two phases: Phase 1 determines the safe dosage and observes how the body processes the drug; Phase 2 evaluates its effectiveness specifically in pediatric/young adult patients with recurrent Ewing sarcoma after previous treatments.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects of Lurbinectedin may include fatigue, nausea, hair loss (alopecia), decreased appetite, constipation or diarrhea as common chemotherapy-related reactions.

EMERGE 101 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed solid tumor.
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I can do most activities but need help with some.
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My bone marrow is functioning well.
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My kidneys are working well.
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I weigh at least 15 kilograms.
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I am able to understand and sign the consent form.

EMERGE 101 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: predose up to approximately 168 hours postdose; days 16, 31, 46: predose up to approximately 5 minutes postdose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: predose up to approximately 168 hours postdose; days 16, 31, 46: predose up to approximately 5 minutes postdose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Phase 1: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
Phase 2: Objective Response Rate (ORR) Based on Investigator Assessment (IA)
Secondary outcome measures
Phase 1: Area Under the Plasma Concentration-Time Curve (AUC) of Lurbinectedin
Phase 1: Clearance (CL) of Lurbinectedin
Phase 1: Clinical Benefit Rate (CBR) With Stable Disease (SD) for At Least 12 Weeks
+19 more

EMERGE 101 Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment1 Intervention
If a signal of efficacy is observed in Phase 1 Part 2, additional participants aged ≥ 2 to ≤ 30 years with recurrent/refractory Ewing sarcoma will be enrolled. Phase 2 will further assess the safety and efficacy of lurbinectedin monotherapy.
Group II: Phase 1 Part 2: RP2DExperimental Treatment1 Intervention
Participants aged ≥ 2 to ≤ 30 years with recurrent/refractory Ewing sarcoma at the RP2D to assess safety and efficacy signals.
Group III: Phase 1 Part 1: Dose SelectionExperimental Treatment1 Intervention
Pediatric participants ≥ 2 to < 18 years of age with previously treated solid tumors of any histology at 5 dose levels to determine the RP2D, followed by a safety expansion cohort. Participants aged ≥ 6 to < 18 years will be enrolled at the starting dose of 3.2 mg/m^2 lurbinectedin. After the drug is deemed safe based safety and PK data from the older participants, participants aged ≥ 2 to < 6 years are enrolled at the same starting dose. After this, the study opens to all participants (aged ≥ 2 to < 18 years) for all dose levels. Upon completion of the cohort at all dose levels, participants may be eligible to enroll in a safety expansion cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lurbinectedin
2022
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,299 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
56 Patients Enrolled for Ewing Sarcoma
Jazz Study DirectorStudy DirectorJazz Pharmaceuticals
1 Previous Clinical Trials
160 Total Patients Enrolled

Media Library

Lurbinectedin (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT05734066 — Phase 1 & 2
Ewing Sarcoma Research Study Groups: Phase 1 Part 1: Dose Selection, Phase 1 Part 2: RP2D, Phase 2
Ewing Sarcoma Clinical Trial 2023: Lurbinectedin Highlights & Side Effects. Trial Name: NCT05734066 — Phase 1 & 2
Lurbinectedin (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05734066 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project include participants aged 45 and older?

"As per the study's entrance requirements, only those aged between 2 and 30 are eligible for enrollment."

Answered by AI

Is this endeavor presently taking on new participants?

"Clinicaltrials.gov reveals that this medical trial is actively searching for patients, having been initially posted on March 1st 2023 and last edited on March 9th of the same year."

Answered by AI

What is the cap on the number of participants in this clinical experiment?

"Affirmative. According to the clinicaltrials.gov records, this research endeavor is actively recruiting participants. The investigation was initially posted on March 1st 2023 and was last revised 9 days later; thus far, 60 individuals across a single site are needed for completion of the trial."

Answered by AI

What are the requirements for participation in this research project?

"This clinical trial is currently open to 60 patients that have experienced a relapse of ewing sarcoma and are aged between 2-30. Essential criteria for admittance include: Phase 1 Part 1 requiring ages ≥2 to <18 years, Phase 1 Part 2 needing participants ≥2 to ≤30 years old, the same age requirement in Phase 2, confirmed solid tumor diagnosis with Lansky/Karnofsky performance status score at or above 50%, aspartate aminotransferase (AST) & alanine aminotransferase (ALT) levels below twice the upper limit of normal values; total bilir"

Answered by AI
~40 spots leftby Dec 2026