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A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil) To Reduce Cancer-Related Fatigue in Patients With Glioblastoma Multiforme


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Fatigue

Thank you

Trial Information

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.


Inclusion Criteria:



- Glioblastoma multiforme who are clinically stable and have completed radiation
therapy > 28 days and ≤ 24 months prior to enrollment; NOTE: clinical stability will
be defined as a stable or improved Karnofsky Performance Status (KPS) compared to the
prior month.

- ≥ 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory)

- Undergone surgery (gross total or subtotal resection) or biopsy and will have been
treated with concurrent radiation therapy and chemotherapy as standard of care for
glioblastoma; Note: radiation must be completed, but chemotherapy is allowed

- Negative serum pregnancy test done ≤ 7 days prior to registration, for women of
childbearing potential only, per physician discretion

- Ability to complete questionnaire(s) by themselves or with assistance

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, 2 or 3

- Provide informed written consent

- Willing to return to enrolling institution for follow-up (during the Active
Monitoring Phase of the study)
* Note: during the Active Monitoring Phase of a study
(i.e., active treatment and observation), participants must be willing to return to
the consenting institution for follow-up

- Stable dose of corticosteroid ≤ 28 days prior to registration

Exclusion Criteria:

- Any of the following because this study involves an agent whose genotoxic, mutagenic
and teratogenic effects on the developing fetus and newborn are unknown in pregnant
women, nursing women, men or women of childbearing potential who are unwilling to
employ adequate contraception

- History of hypersensitivity to other psychostimulants

- History of steroid psychosis

- History of or currently taking medications for attention deficit hyperactivity
disorder, severe anxiety disorder, schizophrenia, or substance abuse by patient
record and/or self report

- Currently using any other pharmacologic agents or nonpharmacologic interventions to
specifically treat fatigue including psychostimulants, antidepressants, acupuncture,
etc. will be excluded; Note: antidepressants used to treat items other than fatigue
(such as hot flashes or depression) are allowed if the patient has been on a stable
dose for ≥ 30 days and plans to continue for the duration of the trial;

erythropoietin agents to treat anemia are allowed; exercise is allowed

- Anticipating surgery, those with hypothyroidism, profound anemia (hemoglobin level of
< 10 g/dL ≤ 28 days prior to registration), and clinical depression per physician
discretion

- Active or a history of Tourette's syndrome or tic disorder

- History of or active glaucoma

- History of intractable epilepsy, or uncontrolled seizure disorder

- Co-morbid systemic illnesses or other severe concurrent disease which, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens

- Receiving any medications or substances that are strong or moderate inhibitors of
cytochrome P450 3A4 (CYP3A4); use of the following strong or moderate inhibitors are
prohibited ≤ 7 days prior to registration:

- Strong Inhibitors of CYP3A4:
 > 5-fold increase in the plasma area under the curve
(AUC) values or more than 80% decrease in clearance
: Indinavir (Crixivan®)

Nelfinavir (Viracept®)
 Atazanavir (Reyataz®)
 Ritonavir (Norvir®)
 Clarithromycin
(Biaxin®, Biaxin XL®)
 Itraconazole (Sporanox®)
 Ketoconazole (Nizoral®)
 Nefazodone
(Serzone®)
 Saquinavir (Fortovase®, Invirase®)
 Telithromycin (Ketek®)


- Moderate Inhibitors of CYP3A4
: > 2-fold increase in the plasma AUC values or 50-80%
decrease in clearance
: Aprepitant (Emend®) Erythromycin (Erythrocin®, E.E.S. ®,
Ery-Tab®, Eryc®, EryPed®, PCE®
 Fluconazole (Diflucan®)
 Grapefruit juice
 Verapamil
(Calan®, Calan SR®, Covera-HS®, Isoptin SR®, Verelan®, Verelan PM®) Diltiazem
(Cardizem®, Cardizem CD®, Cardizem LA®, Cardizem SR®, Cartia XT™) Dilacor XR®, Diltia
XT®, Taztia XT™, Tiazac®)

- Receiving any medications or substances that are inducers of CYP3A4; use of the
following inducers are prohibited ≤ 7 days prior to registration:


- Inducers of CYP3A4: Efavirenz (Sustiva®)
 Nevirapine (Viramune®)
 Carbamazepine
(Carbatrol®, Epitol®, Equetro™, Tegretol®, Tegretol-XR®)
 Modafinil (Provigil®)

Phenobarbital (Luminal®)
 Phenytoin (Dilantin®, Phenytek®)
 Pioglitazone (Actos®)

Rifabutin (Mycobutin®)
 Rifampin (Rifadin®) St. John's Wort

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

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).

Outcome Time Frame:

Up to 8 weeks

Safety Issue:

No

Principal Investigator

Alyx B. Porter Umphrey, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

A221101

NCT ID:

NCT01781468

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Fatigue
  • Fatigue
  • Glioblastoma
  • Gliosarcoma

Name

Location

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