A Phase II Evaluation of MLN8237 (NSC #747888 IND #113149) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
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 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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
6 months
No
David Hyman
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2012-01982
NCT01637961
August 2012
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Hurley Medical Center | Flint, Michigan 48503 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
Florida Hospital | Orlando, Florida 32803 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
University of Hawaii | Honolulu, Hawaii 96813 |
McFarland Clinic | Ames, Iowa 50010 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Hawaii Minority Based CCOP | Honolulu, Hawaii 96813 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |