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A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma

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Trial Profile

A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 Jan 2025

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At a glance

  • Drugs Lurbinectedin (Primary)
  • Indications Ewing's sarcoma; Solid tumours
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms EMERGE 101
  • Sponsors Jazz Pharmaceuticals Inc

Most Recent Events

  • 04 May 2023 Planned initiation date changed from 1 Mar 2023 to 1 May 2023.
  • 09 Mar 2023 Planned initiation date changed from 1 Feb 2023 to 1 Mar 2023.
  • 09 Mar 2023 Status changed from not yet recruiting to recruiting.

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