NCT03810976

A Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma

Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients With Advanced Liposarcoma or Leiomyosarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The eribulin, a microtubule-dynamics inhibitor was approved for specific subtypes of STS. Eribulin demonstrated significantly better OS compared to dacarbazine in previously treated patients with liposarcoma and leiomyosarcoma and approved as standard treatment. However, the median progression free survival (PFS) and response rate (RR) was similar for both groups which remains modest outcome of 2.6 months of PFS and 4% of RR. Therefore, to improve antitumor activity, further combination strategy is strongly warranted. Based on the previous studies, investigators suggest phase II trial of eribulin and gemcitabine combination in previously treated patients with unresectable, advanced, or metastatic leiomyosarcoma or liposarcoma.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	Eribulin, gemcitabine	Elibulin 1.4mg/m2 Intravenous for 5minutes. Day 1\& Day 8 every 3 weeks Gemcitabine 1000mg/m2 intraveoust for 30 minutes, Day 1\& Day 8 every 3 weeks

Timeline

• Start date: 2018-03-27
• Primary completion: 2022-05-30
• Completion: 2022-05-30
• First posted: 2019-01-22
• Last updated: 2022-06-16

Locations

1 site across 1 country: South Korea