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Title
Status

 

JZP712-101 - 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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JZP712-101 - 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.

Go to Health Care Provider version

DiagnosisRelapsed/Refractory Ewing SarcomaStudy StatusOpen
PhaseI/II
Age2 Years to 30 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Lurbinectedin Administered as intravenous (IV) infusion once every 3 weeks (Q3W)
Last Posted Update2024-09-26
ClinicalTrials.gov #NCT05734066
International Sponsor
Jazz Pharmaceuticals
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

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