Lurbinectedin in FET-Fused Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05918640
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Desmoplastic Small Round Cell Tumor
  • Ewing Sarcoma
  • Pediatric Cancer
  • Undifferentiated Sarcoma

Eligibility Criteria

Sex
ALL
Age
10 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lurbinectedin — DRUG
    Lurbinectedin will be administered on a Day 1, Day 4 schedule every 21 days. Doses will be determined in the phase 1 portion of the trial.

Study Details

The purpose of this study is to find out if a drug called lurbinectedin (the "study drug") is safe and effective at treating people with recurrent or relapsed solid tumors, including Ewing sarcoma.

Key Dates

Start date
Jul 27, 2023
Status verified
Mar 2026
Primary completion
Jul 30, 2027
Completion
Jul 30, 2028

Study Design

Enrollment
63 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ewing Sarcoma
    The first part of this study is a standard 3+3 design to test the safety, tolerability and pharmacokinetic profile of lurbinectedin administered on a day 1, 4 schedule in patients with FET-fusion tumors.

Primary Outcome Measure

Phase 1: Dose Limiting Toxicities (DLTs) [ Time Frame: within 28 days of the first dose ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Leo Mascarenhas, MD
[email protected]
310-423-4423
Emilie Douine-Barthelemy
[email protected]
310-967-0692
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Jenna Gedminas, MD
[email protected]
319-353-6393
Chris Stamy
[email protected]
319-356-7875
Jenna Gedminas, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Steven Dubois, MD
[email protected]
617-632-5460
Alexandra Sala
[email protected]
857-215-2410
Steven Dubois, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Rashmi Chugh, MD
[email protected]
800-865-1125
Cancer AnswerLine
[email protected]
1-800-865-1125
Rashmi Chugh, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Julia Glade Bender, MD
[email protected]
212-639-6729
Robert Maki, MD
[email protected]
646-888-5059
Julia Glade Bender, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Theodore Laetsch, MD
[email protected]
267-425-5544
Meghan Donnelly
[email protected]
267-426-9343

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of Iowa Hospitals and Clinics· Iowa City, IADana-Farber Cancer Institute· Boston, MAUniversity of Michigan· Ann Arbor, MIMemorial Sloan Kettering Cancer Center· New York, NYChildren's Hospital of Philadelphia· Philadelphia, PA

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