NCT02097238

Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma

A Phase II Study of Eribulin (NSC# 707389) in Recurrent or Refractory Osteosarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 12 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well eribulin mesylate works in treating patients with osteosarcoma that has come back after treatment (recurrent) or has not responded to treatment (refractory). Microtubule inhibitors, such as eribulin mesylate, may stop or slow the growth of tumor cells by disrupting the cell cycle.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the 4 month progression free survival rate and objective response rate in patients with recurrent osteosarcoma who are administered eribulin (eribulin mesylate) therapy on day 1 and day 8 of 21 day cycles. SECONDARY OBJECTIVES: I. To investigate the pharmacokinetics (PK) of eribulin in subjects with recurrent osteosarcoma. II. To further describe the tolerability of single agent eribulin. OUTLINE: Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up annually for 5 years.

Conditions

• Recurrent Osteosarcoma

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	Given IV
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-06-30
• Completion: 2020-03-31
• First posted: 2014-03-27
• Last updated: 2020-05-19
• Results posted: 2017-09-01

Locations

119 sites across 2 countries: United States, Canada