Phase II Study of MLN8237 in Advanced / Metastatic Sarcoma
PRIMARY OBJECTIVES:
I. To determine the response rate (complete response [CR] + partial response [PR]) assessed
for patients within each cohort: liposarcoma (cohort 1); leiomyosarcoma (non-uterine)
(cohort 2); undifferentiated sarcoma (including pleomorphic undifferentiated sarcoma,
formerly known as malignant fibrous histiocytoma, and myxofibrosarcoma) (cohort 3);
malignant peripheral nerve sheath tumor (cohort 4); and other sarcomas (cohort 5).
SECONDARY OBJECTIVES:
I. To estimate the progression-free survival (PFS) and overall survival (OS) for patients
treated with alisertib (MLN8237) in each cohort.
II. To assess the adverse events associated with patients treated with MLN8237 in each
cohort.
TERTIARY OBJECTIVES:
I. To correlate potential clinical benefit with markers of aurora kinase inhibition in pre-
and post-treatment tumor biopsies.
II. To correlate clinical outcome with change in fluorine F 18 fluorothymidine
(FLT)-positron emission tomography (PET) uptake at baseline versus after one week of
treatment (i.e., week 2 of cycle 1).
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 for up to 18 months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The confirmed response rate (CR/PR)
The overall response rate (CR + PR) will be estimated and a 90% confidence interval provided.
Up to 18 months
No
Mark Dickson
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2012-01991
NCT01653028
August 2012
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Loyola University Medical Center | Maywood, Illinois 60153 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
Boston Medical Center | Boston, Massachusetts 02118 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Grandview Hospital | Dayton, Ohio 45405 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Mountainview Medical | Berlin, Vermont 05602 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Bixby Medical Center | Adrian, Michigan 49221 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Menorah Medical Center | Overland Park, Kansas 66209 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Wayne Hospital | Greenville, Ohio 45331 |
Longmont United Hospital | Longmont, Colorado 80501 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Saint Francis Medical Center | Grand Island, Nebraska 68802 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
Northwestern University | Chicago, Illinois 60611 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Glens Falls Hospital | Glens Falls, New York 12801 |
Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
University Of Vermont | Burlington,, Vermont 05403 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Flower Hospital | Sylvania, Ohio 43560-2197 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Castle Medical Center | Kailua, Hawaii 96734 |
Southeast Cancer Center | Cape Girardeau, Missouri 63703 |
Froedtert and the Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
The Medical Center of Aurora | Aurora, Colorado 80012 |
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado 80907 |
Saint Anthony Central Hospital | Denver, Colorado 80204 |
Exempla Saint Joseph Hospital | Denver, Colorado 80218 |
Colorado Cancer Research Program CCOP | Denver, Colorado 80224-2522 |
Saint Mary Corwin Medical Center | Pueblo, Colorado 81004 |
John B Amos Cancer Center | Columbus, Georgia 31904 |
Oncare Hawaii Inc-POB II | Honolulu, Hawaii 96813 |
Oncare Hawaii Inc-Kuakini | Honolulu, Hawaii 96817 |
University of Hawaii | Honolulu, Hawaii 96813 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
McFarland Clinic | Ames, Iowa 50010 |
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa 50325 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Hickman Cancer Center | Adrian, Michigan 49221 |
Green Bay Oncology - Escanaba | Escanaba, Michigan 49431 |
Green Bay Oncology - Iron Mountain | Iron Mountain, Michigan 49801 |
Mercy Memorial Hospital | Monroe, Michigan 48162 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Saint Cloud Hospital | Saint Cloud, Minnesota 56303 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Missouri Baptist Medical Center | Saint Louis, Missouri 63131 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Hematology Oncology Center Incorporated | Elyria, Ohio 44035 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center | Maumee, Ohio 43537 |
Saint Charles Hospital | Oregon, Ohio 43616 |
Toledo Community Hospital Oncology Program CCOP | Toledo, Ohio 43617 |
Mercy Cancer Center at Saint Anne Mercy Hospital | Toledo, Ohio 43623 |
University of Toledo | Toledo, Ohio 43614 |
Saint Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Wright-Patterson Medical Center | Wright-Patterson Afb, Ohio 45433-5529 |
Natalie W Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Sanford Cancer Center-Oncology Clinic | Sioux Falls, South Dakota 57104 |
Fredericksburg Oncology Inc | Fredericksburg, Virginia 22401 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology at Saint Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood, Florida 33021 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
UMDNJ - New Jersey Medical School | Newark, New Jersey 07103 |
Community Health Partners Regional Medical Center | Elyria, Ohio 44035 |
Holy Family Memorial Hospital | Manitowoc, Wisconsin 54221 |
Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue, Hawaii 96766-1099 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Kansas City CCOP | Prairie Village, Kansas 66208 |
Capital Region Medical Center-Goldschmidt Cancer Center | Jefferson City, Missouri 65109 |
Heartland Hematology and Oncology Associates Incorporated | Kansas City, Missouri 64118 |
Saint Joseph Oncology Inc | Saint Joseph, Missouri 64507 |
Saint Nicholas Hospital | Madison, Wisconsin 53715 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Methodist West Hospital | West Des Moines, Iowa 50266-7700 |
Carle Foundation - Carle Cancer Center | Urbana, Illinois 61801 |
Sanford Clinic North-Fargo | Fargo, North Dakota 58102 |
Franciscan St. Francis Health | Indianapolis, Indiana 46237 |
The Toledo Hospital/Toledo Children's Hospital | Toledo, Ohio 43606 |
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota 57117-5134 |
Sanford Clinic North-Bemidgi | Bemidji, Minnesota 56601 |
Toledo Clinic Cancer Centers-Oregon | Oregon, Ohio 43616 |
Memorial Sloan-Kettering Cancer Center at Suffolk | Commack, New York 11725 |
Toledo Clinic Cancer Centers-Bowling Green | Bowling Green, Ohio 43402 |
Toledo Clinic Cancer Centers-Maumee | Maumee, Ohio 43537-1839 |
Toledo Clinic Cancer Centers-Toledo | Toledo, Ohio 43623 |
Mercy Cancer Center-West Lakes | Clive, Iowa 50325 |
Mercy Medical Center-West Lakes | West Des Moines, Iowa 50266 |
Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |