NCT03441360

Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS)

A Phase 2, Multicenter, Open-label Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Subjects With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 12 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted as an assessment of the safety and preliminary activity of eribulin mesylate in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), or Ewing sarcoma (EWS) to determine whether each cohort warrants further investigation.

Conditions

• Relapsed/Refractory Rhabdomyosarcoma
• Non-rhabdomyosarcoma Soft Tissue Sarcoma
• Ewing Sarcoma

Interventions

Type	Name	Description
DRUG	Eribulin mesylate	Intravenous infusion

Timeline

• Start date: 2018-04-17
• Primary completion: 2021-01-07
• Completion: 2022-01-21
• First posted: 2018-02-22
• Last updated: 2022-10-05
• Results posted: 2022-01-28

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated drug study