Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies how well alisertib works in treating patients with leiomyosarcoma of the uterus that has come back or persistent. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01637961
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date August 2012
Completion date February 11, 2017

See also
  Status Clinical Trial Phase
Completed NCT01168232 - Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT00025220 - Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus Phase 2
Completed NCT00025506 - Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus Phase 2
Completed NCT01220609 - Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy Phase 2
Terminated NCT01012297 - Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma Phase 3
Completed NCT01548482 - Trebananib And Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Completed NCT00114218 - Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT01154452 - Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma Phase 1/Phase 2
Completed NCT01098630 - Patient, Physician, and Nurse Factors Associated With Entry Onto Clinical Trials and Finishing Treatment in Patients With Primary or Recurrent Uterine, Endometrial, or Cervical Cancer
Completed NCT01247571 - Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT00031629 - Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus Phase 2