Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
With
PRIMARY OBJECTIVES: I. To assess the clinical activity of MLN8237 (alisertib) in patients with recurrent or persistent leiomyosarcoma of the uterus who have received one or two prior cytotoxic therapies and the frequency of patients who survive progression-free for at least 6 months after initiating therapy or have objective tumor response. SECONDARY OBJECTIVES: I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) among women with leiomyosarcoma treated with MLN8237. II. To determine the distribution of progression-free survival (PFS) and overall survival (OS). TERTIARY OBJECTIVES: I. To determine the relationship of Aurora A Kinase expression, measured by immunohistochemistry, with objective response, PFS at 6 months, survival, and progression-free survival. OUTLINE: Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
