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| Diagnosis | Relapsed/Refractory Ewing Sarcoma | Study Status | Open |
| Phase | I/II |
| Age | 2 Years to 30 Years | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Drug: Lurbinectedin
Administered as intravenous (IV) infusion once every 3 weeks (Q3W) |
| Last Posted Update | 2023-09-08 |
| ClinicalTrials.gov # | NCT05734066 |
International Sponsor
Jazz PharmaceuticalsPrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Study Description
This study is to test the safety of a drug called lurbinectedin in solid tumours that have come back (relapsed) or not responded to treatment (refractory). It is conducted in 2 parts, Phase 2 will further assess this drug in participants with Ewing sarcoma specifically.
Inclusion Criteria
- Participant must meet the following age requirements:
- Phase 1 Part 1: participants must be ≥ 2 to < 18 years of age.
- Phase 1 Part 2: participants must be ≥ 2 to ≤ 30 years of age.
- Phase 2: participants must be ≥ 2 to ≤ 30 years of age.
- Participant has a confirmed solid tumor (For phase 2, Ewing Sarcoma)
- The participant is up and about for more than half their waking hours
- Participant meets all lab value requirements during the screening period
- Participant weighs at least 15kg
- Must not be pregnant (if applicable), and/or must be on an acceptable birth control method
- Must sign informed consent and agree to attending all required study assessments
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team
