drugset / Trial / NCT03810976

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

NCT03810976

Phase 2 Completed 37 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-03-27
Primary completion
2022-05-30
Completion
2022-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Eribulin Small molecule 1.4 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications