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

Recruiting Phase 1 Phase 2 Interventional Study
Refractory Ewing Sarcoma Relapsed Ewing Sarcoma Ewing Sarcoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 30
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Jazz Pharmaceuticals · Industry
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About This Trial
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 particip…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: Age * Participant must meet the following age requirements at the time the informed consent form (ICF) (and assent form, if applicable) is signed: * Phase 1 Part 1: participants must be ≥ 2 to \< 18 years of age. * Phase 1 Part 2: participants must be ≥ 2 to ≤ 30 years…
Contacts

Clinical Trial Disclosure & Transparency

215-832-3750

ClinicalTrialDisclosure@JazzPharma.com

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