Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05734066 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 1/2
Started2023-05-23
View on ClinicalTrials.gov ↗

Amendment history

2026-01-30
Study Status, Sponsor/Collaborators, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v8
Primary completion date2026-12-01→2028-01-28
Completion date2027-06-01→2028-04-20
Eligibility criteria+80 characters
[...] d by the following: Absolute neutrophil count (ANC) ≥ 1.0 × 10910^9/L (independent of growth factor support within 1 week of screening laboratories). Platelets ≥ 100 × 10910^9/L (without platelet transfusion within previous 7 days of s [...] corrected QT interval (QTc) prolongation defined as a QTc ≥ 460 ms using the Bazett formula in age < 18 years and QTc ≥ 470 ms using the Bazett formula in age ≥ 18 years. Known symptomatic Central nervous system (CNS) metastases [...]
Secondary endpoints22 to 38 entries
Phase 1: Maximum Plasma Concentration (Cmax) of Lurbinectedin Phase 1: PlasmaChange TroughFrom ConcentrationBaseline (Ctrough)in ofRespiratory LurbinectedinRate Phase 1: PlasmaChange ConcentrationFrom atBaseline thein EndPulse of Infusion (CEOI) of LurbinectedinRate Phase 1: AreaChange UnderFrom theBaseline Plasmain Concentration-TimeBlood Curve (AUC) of LurbinectedinPressure Phase 1: ClearanceChange (CL)From ofBaseline Lurbinectedinin Weight Phase 1: VolumeChange offrom DistributionBaseline atin Steady-StatePlatelet (Vss)Count Phase of1: LurbinectedinChange from Baseline in Red Blood Cell Cou [...] [...]
Primary endpoints3 to 5 entries
Phase 1: Number of Participants Experiencing Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) Phase 1: Number of Participants Who Discontinued Study Intervention Due to TEAEs Phase 1: Number of Participants With Dose Modifications
Study sites15 entries, revised
Children's Hospital of Los Angeles StanfordLucile Packard Children's HealthHospital ChildrensChildren's National Hospital Michigan Arthur M. Blank Hospital Children's Healthcare of Atlanta at Arthur M. Blank Hospital Memorial Sloan Kettering Cancer Center Nationwide ChildrensChildren's Hospital UTChildren's SouthwesternHealth inDallas The University of Texas MD Anderson Cancer Center
Collaborators+36 characters
Jazz Pharmaceuticals Ireland Limited
2025-01-21
Study Identification, Study Status, Contacts/Locations v7
Study sites13→15
2024-10-09
Study Status, Eligibility, Contacts/Locations v6
Primary completion date2026-12→2026-12-01
Completion date2027-06→2027-06-01
Study sites7→13
Eligibility criteriarevised
[...] ptive method during the study intervention period (at least 67 months after the last dose of study intervention). The inve [...]
2023-10-31
Study Status, Contacts/Locations v5
Study sites4→7
2023-07-26
Study Status, Contacts/Locations v4
Start dateestimated 2023-05→confirmed 2023-05-23
Study sites2→4
Show 3 earlier versions
2023-05-04
Study Status v3
Start date2023-03→2023-05
2023-03-28
Study Status, Contacts/Locations v2
Study sites1→2
2023-03-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2023-02→2023-03
Study sites0→1
2023-02-15
Original filing
Jazz Pharmaceuticals
34 trials monitored
See 1 trial at risk
Sarcoma
947 trials monitored
See 53 trials at risk
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 participants with recurrent/refractory Ewing sarcoma.
Trial Details
NCT Number NCT05734066
Lead Sponsor Jazz Pharmaceuticals
Collaborators: Jazz Pharmaceuticals Ireland Limited
Conditions Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Ewing Sarcoma
Enrollment 60 participants
Start Date 2023-05-23
Primary Completion 2028-01-28 (estimated)
Study Completion 2028-04-20 (estimated)
Updated on ClinicalTrials.gov 2026-02-03