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Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma

Recurrent Osteosarcoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02097238
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date August 2014
Completion date March 31, 2020
View Details
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