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