A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil) To Reduce Cancer-Related Fatigue in Patients With Glioblastoma Multiforme
PRIMARY OBJECTIVES:
I. To determine preliminary efficacy measured by patient reported fatigue (Brief Fatigue
Inventory [BFI]) at 8 weeks of two doses (150mg and 250mg) of armodafinil in treating
moderate fatigue compared to placebo in patients with glioblastoma.
SECONDARY OBJECTIVES:
I. To evaluate the tolerability at 8 weeks of 150mg and 250mg armodafinil in this patient
population.
II. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with
glioblastoma.
III. To assess the impact of armodafinil on global quality of life and other fatigue
endpoints (i.e. usual fatigue, activity interference) in this patient population with
glioblastoma.
IV. Explore the correlation between the BFI, Patient-Reported Outcomes Measurement
Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology
Criteria for Adverse Events (PRO-CTCAE) measures, as well as the relationship of fatigue and
cognitive difficulties.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive lower-dose armodafinil orally (PO) once daily (QD) on days 1-28.
ARM II: Patients receive placebo PO QD on days 1-28.
ARM III: Patients receive higher-dose armodafinil PO QD on days 1-28.
In all arms, treatment repeats every 28 days for 2 courses.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Response rate in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks. A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI).
Up to 8 weeks
No
Alyx B. Porter Umphrey, M.D.
Study Chair
Mayo Clinic
United States: Food and Drug Administration
A221101
NCT01781468
June 2013
Name | Location |
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Washington University School of Medicine | Saint Louis, Missouri 63110 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
York Hospital | York, Pennsylvania 17315 |
St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
John Muir Medical Center | Walnut Creek, California 94598 |
Great Falls Clinic | Great Falls, Montana 59405 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Associates in Womens Health | Wichita, Kansas 67203 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Community Cancer Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
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 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
St. Francis Hospital | Federal Way, Washington 98003 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Capital Medical Center | Olympia, Washington 98502 |
Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
Holy Family Medical Center | Des Plaines, Illinois 60016 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Bixby Medical Center | Adrian, Michigan 49221 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Miami Valley Hospital | Dayton, Ohio 45409 |
St. Mary's Hospital Medical Center | Green Bay, Wisconsin 54303 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
Northern Montana Hospital | Havre, Montana 59501 |
Wayne Hospital | Greenville, Ohio 45331 |
Providence Centralia Hospital | Centralia, Washington 98531-9027 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Auburn Regional Center for Cancer Care | Auburn, Washington 98002 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Cancer Centers of the Carolinas - Grove Commons | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Phelps County Regional Medical Center | Rolla, Missouri 65401 |
Sacred Heart Hospital | Pensacola, Florida 32503 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Cancer Centers of the Carolinas - Easley | Easley, South Carolina 29640 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Florida Hospital | Orlando, Florida 32803 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
St. Nicholas Hospital | Sheboygan, Wisconsin 53081 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
Sacred Heart Medical Oncology Group - Davis Highway | Pensacola, Florida 32514 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Cedar Rapids Oncology Association | Cedar Rapids, Iowa 52403 |
Mercy Hospital | Cedar Rapids, Iowa 52403 |
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-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Lakeland Hospital | St. Joseph, Michigan 49085 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Kinston Medical Specialists PA | Kinston, North Carolina 28501 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Saint Charles Hospital | Oregon, Ohio 43616 |
Toledo Community Hospital Oncology Program CCOP | Toledo, Ohio 43617 |
University of Toledo | Toledo, Ohio 43614 |
Saint Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Legacy Good Samaritan Hospital and Medical Center | Portland, Oregon 97210 |
Greenville Memorial Hospital | Greenville, South Carolina 29605 |
Northwest CCOP | Tacoma, Washington 98405 |
Saint Joseph Medical Center | Tacoma, Washington 98405 |
Green Bay Oncology Limited at 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 |
Overlake Cancer Center at Overlake Hospital Medical Center | Bellevue, Washington 98004 |
Elkhart Clinic | Elkhart, Indiana 46515 |
John Muir Medical Center-Concord Campus | Concord, California 94520 |
Illinois CancerCare-Kewanee Clinic | Kewanee, Illinois 61443 |
Michiana Hematology Oncology PC-Elkhart | Elkhart, Indiana 46514 |
Michiana Hematology Oncology PC-Plymouth | Plymouth, Indiana 46563 |
Michiana Hematology Oncology PC-South Bend | South Bend, Indiana 46601 |
Michiana Hematology Oncology-PC Westville | Westville, Indiana 46391 |
Cancer Centers of the Carolinas - Faris | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas-Greer Medical Oncology | Greer, South Carolina 29650 |
Holy Family Memorial Hospital | Manitowoc, Wisconsin 54221 |
Adams Cancer Center | Gettysburg, Pennsylvania 17325 |
Cherry Tree Cancer Center | Hanover, Pennsylvania 17331 |
Cancer Centers of North Carolina | Raleigh, North Carolina 27607 |
Saint Joseph Regional Medical Center | Lewiston, Idaho 83501 |
Providence Regional Cancer Partnership | Everett, Washington 98201 |
Legacy Salmon Creek Hospital | Vancouver, Washington 98686 |
Cancer Center of Kansas, PA - McPherson | McPherson, Kansas 67460 |
Providence Western Washington Oncology | Lacey, Washington 98503 |
Illinois CancerCare | Bloomington, Illinois 61701 |
Michiana Hematology Oncology PC-Mishawaka | Mishawaka, Indiana 46545-1470 |
Oncology Associates at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
Marie Yeager Cancer Center | Saint Joseph, Michigan 49085 |
Hematology Oncology Associates of Central New York PC | East Syracuse, New York 13057 |
Franciscan St. Francis Health | Indianapolis, Indiana 46237 |
The Toledo Hospital/Toledo Children's Hospital | Toledo, Ohio 43606 |
Community Howard Regional Health | Kokomo, Indiana 46904 |
Indiana University Health La Porte Hospital | La Porte, Indiana 46350 |
Saint Joseph Regional Medical Center-Mishawaka | Mishawaka, Indiana 46545-1470 |
Baptist Health Lexington | Lexington, Kentucky 40503 |
Siouxland Hematology Oncology Associates LLP | Sioux City, Iowa |
John Muir Medical Center - Concord Campus | Concord, California 94520 |
Illinois CancerCare-Bloomington Clinic | Bloomington, Illinois 61701 |
Illinois CancerCare-Canton Clinic | Canton, Illinois 61520 |
Illinois CancerCare-Carthage Clinic | Carthage, Illinois 62321 |
Illinois CancerCare-Eureka Hospital | Eureka, Illinois 61530 |
Illinois CancerCare-Galesburg Clinic | Galesburg, Illinois 61401 |
Illinois CancerCare-Macomb Clinic | Macomb, Illinois 61455 |
Illinois CancerCare-Monmouth Clinic | Monmouth, Illinois 61462 |
Illinois CancerCare-Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois CancerCare-Peru Clinic | Peru, Illinois 61354 |
Illinois CancerCare-Princeton Clinic | Princeton, Illinois 61356 |
McFarland Clinic - Mary Greenley Medical Center | Ames, Iowa 50010 |
Toledo Clinic Cancer Centers - Adrian | Adrian, Michigan 49221 |
Toledo Clinic Cancer Centers - Monroe | Monroe, Michigan 48162 |
Central Care Cancer Center - Carrie J. Babb Cancer Center | Bolivar, Missouri 65613 |
Cox Cancer Center Skaggs Community Health Center - Branson | Branson, Missouri 65616 |
Mercy Clinic-Rolla-Cancer and Hematology | Rolla, Missouri 65401 |
Ozark Health Ventures LLC dba Cancer Research for the Ozarks - Springfield | Springfield, Missouri 65804 |
Mercy Hospital - Springfield | Springfield, Missouri 65804 |
Lester E. Cox Medical Center | Springfield, Missouri 65807 |
Frontier Cancer Center and Blood Institutes - Billings | Billings, Montana 59102 |
Benefis Healthcare - Sletten Cancer Institute | Great Falls, Montana 59405 |
Toledo Clinic Cancer Centers - Bowling Green | Bowling Green, Ohio 43402 |
Community Health Partners Regional Medical Center - Mercy Cancer Center | Elyria, Ohio 44035 |
Hematology Oncology Center Inc. | Elyria, Ohio 44035 |
Toledo Radiation Oncology at Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Toledo Clinic Cancers Centers - Maumee | Maumee, Ohio 43537 |
Toledo Clinic Cancer Centers - Oregon | Oregon, Ohio 43616 |
Hickman Cancer Center - Flower Hospital | Sylvania, Ohio 43560 |
Toledo Clinic Cancer Centers - Toledo | Toledo, Ohio 43623 |
Mercy Cancer Center - Saint Anne Mercy Hospital | Toledo, Ohio 43623 |
Surgical Partners | Toledo, Ohio 43623 |
Geisinger Wyoming | Wilkes-Barre, Pennsylvania 18711 |
Greenville Cancer Center of the Carolinas (CCOP) | Greenville, South Carolina 29615 |
Avera Medical Group Oncology and Hematology Aberdeen | Aberdeen, South Dakota 57401 |
Huntsman Cancer Institute - University of Utah | Salt Lake City, Utah 84112 |
Fredericksburg Oncology Inc. | Fredericksburg, Virginia 22401 |
Capital Oncology PLLC | Olympia, Washington 98502 |
Northwest Medical Specialists PLLC | Tacoma, Washington 98405 |
Multicare Health System - Tacoma General Hospital | Tacoma, Washington 98415 |