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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jazz Pharmaceuticals
Study ID
NCT05734066
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Ewing Sarcoma
  • Refractory Ewing Sarcoma
  • Relapsed Ewing Sarcoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Lurbinectedin — DRUG
    Administered as intravenous (IV) infusion once every 3 weeks (Q3W)

Study Details

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.

Key Dates

Start date
May 23, 2023
Status verified
Jan 2026
Primary completion
Jan 28, 2028
Completion
Apr 20, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Part 1: Dose Selection
    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. If, after review, the starting dose of 3.2 mg/m\^2 lurbinectedin Q3W is deemed safe in participants aged ≥ 6 to \< 18 years, participants aged ≥ 2 to \< 6 years may enroll and start at the dose as determined by the DMC. 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.
  • Experimental: Phase 1 Part 2: RP2D
    Participants aged ≥ 2 to ≤ 30 years with recurrent/refractory Ewing sarcoma at the RP2D to assess safety and efficacy signals.
  • Experimental: Phase 2
    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.

Primary Outcome Measure

Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) [ Time Frame: From the first dose through end of Cycle 1 (21 days). ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Children's Hospital of Los AngelesLos AngelesCalifornia90027-
Lucile Packard Children's HospitalPalo AltoCalifornia94304-
Children's National HospitalWashington D.C.District of Columbia20010-
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-
Children's Healthcare of Atlanta at Arthur M. Blank HospitalAtlantaGeorgia30329-
Johns Hopkins UniversityBaltimoreMaryland21238-
Corewell HealthGrand RapidsMichigan49503-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Nationwide Children's HospitalColumbusOhio43205-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
St. Jude Children's Research HospitalMemphisTennessee38105-
Children's Health DallasDallasTexas75235-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital of Los Angeles· Los Angeles, CALucile Packard Children's Hospital· Palo Alto, CAChildren's National Hospital· Washington D.C., DCJohns Hopkins All Children's Hospital· St. Petersburg, FLChildren's Healthcare of Atlanta at Arthur M. Blank Hospital· Atlanta, GAJohns Hopkins University· Baltimore, MD

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