Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus
This phase II trial studies how well alisertib works in treating patients with recurrent or persistent leiomyosarcoma of the uterus. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Recurrent Uterine Sarcoma
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of MLN8237 (NSC# 747888) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus|
- Progression-free survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Objective tumor response, assessed according to RECIST [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Adverse events as assessed by NCI CTCAE version 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]Toxicities will be tabulated by severity and frequency.
- PFS [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Characterized graphically and using descriptive statistics such as median survival.
- OS [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Characterized graphically and using descriptive statistics such as median survival.
- Aurora A Kinase expression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Aurora A Kinase expression will be assessed for associations with patient demographics and clinical outcome (response, PFS at 6 months, PFS, and OS).
|Study Start Date:||August 2012|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (alisertib)
Patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: laboratory biomarker analysis
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.
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).
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637961
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|Principal Investigator:||David Hyman||NRG Oncology|