Armodafinil in Reducing Cancer-Related Fatigue in Patients with High-Grade Glioma

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIISupportive careActive18 and overA221101
NCI-2012-02020, N10C3, NCT01781468

Trial Description

Summary

This randomized phase III trial studies how well armodafinil works in reducing cancer-related fatigue in patients with high-grade glioma. Armodafinil may help relieve fatigue in patients with high-grade glioma.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine preliminary efficacy measured by patient reported fatigue using the Brief Fatigue Inventory (BFI) at 8 weeks of two doses (150 mg and 250 mg) of armodafinil in treating moderate fatigue compared to placebo in patients with high grade glioma.

SECONDARY OBJECTIVES:

I. To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population.

II. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with high grade glioma.

III. To assess the impact of armodafinil on global quality of life and other fatigue endpoints in this patient population with high grade glioma.

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 4 weeks for 2 courses.

Eligibility Criteria

Inclusion Criteria:

Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have completed radiation therapy > 21 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, question 3); it is not required for the patient to complete the entire BFI to meet this criterion

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, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma patients; Note: radiation must be completed, but chemotherapy is allowed

Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician

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)

Stable dose of corticosteroid >= 14 days prior to registration

Exclusion Criteria:

Any of the following:

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 prior to registration and plans to continue for the duration of the trial; erythropoietin agents to treat anemia are allowed; exercise is allowed

Anticipating surgery, laboratory evidence of hypothyroidism with an elevated thyroid-stimulating hormone (TSH) concentration in the blood > 5.0 mlU/L, profound anemia (hemoglobin level of < 10 g/dL =< 28 days prior to registration), or 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

Any of the following 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:

History of myocardial infarction

Unstable angina

Left ventricular hypertrophy

Mitral valve prolapse syndrome

Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (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 (Carbatro, Epitol, Equetro, Tegretol, Tegretol-XR)
  • Modafinil (Provigil)
  • Phenobarbital (Luminal)
  • Phenytoin (Dilantin, Phenytek)
  • Pioglitazone (Acto)
  • Rifabutin (Mycobutin)
  • Rifampin (Rifadin)
  • St. John’s wort

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Alliance for Clinical Trials in Oncology

  • National Cancer Institute
Alyx B. Porter Umphrey, Principal Investigator

Trial Sites

U.S.A.

Alaska
Anchorage

Alaska Breast Care and Surgery LLC

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Alaska Women's Cancer Care

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Anchorage Oncology Centre

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Katmai Oncology Group

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Providence Alaska Medical Center

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Arizona
Phoenix

Saint Joseph's Hospital and Medical Center

David G. Brachman
Ph: 800-360-6371

David G. Brachman
Principal Investigator

Scottsdale

Arizona Oncology Services Foundation

David G. Brachman
Ph: 800-360-6371

David G. Brachman
Principal Investigator

Mayo Clinic in Arizona

Alyx B. Porter Umphrey
Ph: 855-776-0015

Alyx B. Porter Umphrey
Principal Investigator

California
Berkeley

Alta Bates Summit Medical Center-Herrick Campus

Milana V. Dolezal
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Milana V. Dolezal
Principal Investigator

Burlingame

Mills - Peninsula Hospitals

Milana V. Dolezal
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Milana V. Dolezal
Principal Investigator

Fresno

California Cancer Center - North Fresno

Uzair Bashir Chaudhary
Ph: 559-256-9680

Uzair Bashir Chaudhary
Principal Investigator

University Oncology Associates

Uzair Bashir Chaudhary
Ph: 559-256-9680

Uzair Bashir Chaudhary
Principal Investigator

Modesto

Memorial Medical Center

Milana V. Dolezal
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Milana V. Dolezal
Principal Investigator

Orange

Saint Joseph Hospital - Orange

Hector Wanhow Ho
Ph: 714-734-6220

Hector Wanhow Ho
Principal Investigator

UC Irvine Health/Chao Family Comprehensive Cancer Center

Jose A. Carrillo
Ph: 877-827-8839
Email: ucstudy@uci.edu

Jose A. Carrillo
Principal Investigator

Colorado
Colorado Springs

Penrose-Saint Francis Healthcare

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Rocky Mountain Cancer Centers-Penrose

Keren Sturtz
Ph: 303-777-2663
Email: kgeisen@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Wheat Ridge

SCL Health Lutheran Medical Center

Keren Sturtz
Ph: 303-777-2663
Email: kgeisen@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Delaware
Newark

Christiana Care Health System-Christiana Hospital

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Helen F Graham Cancer Center

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Medical Oncology Hematology Consultants PA

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Regional Hematology and Oncology PA

Gregory Andrew Masters
Ph: 302-733-6227

Gregory Andrew Masters
Principal Investigator

Florida
Lakeland

Lakeland Regional Cancer Center

Madhavi L. Venigalla
Ph: 863-904-1900

Madhavi L. Venigalla
Principal Investigator

Miami

University of Miami Miller School of Medicine-Sylvester Cancer Center

Deborah Olin (Beck) Heros
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Deborah Olin (Beck) Heros
Principal Investigator

Pensacola

Sacred Heart Hospital

Thomas Dean Sunnenberg
Ph: 850-416-4611

Thomas Dean Sunnenberg
Principal Investigator

Sacred Heart Medical Oncology Group - Davis Highway

Thomas Dean Sunnenberg
Ph: 850-416-4611

Thomas Dean Sunnenberg
Principal Investigator

Georgia
Atlanta

Piedmont Hospital

Erin M. Dunbar
Ph: 404-425-7943
Email: ORS@piedmont.org

Erin M. Dunbar
Principal Investigator

Idaho
Boise

Saint Alphonsus Cancer Care Center-Boise

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Coeur D'Alene

Kootenai Medical Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Post Falls

Kootenai Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Illinois
Bloomington

Illinois CancerCare-Bloomington

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Canton

Illinois CancerCare-Canton

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Carthage

Illinois CancerCare-Carthage

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Centralia

Centralia Oncology Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Decatur

Cancer Care Center of Decatur

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Decatur Memorial Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Effingham

Crossroads Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Eureka

Illinois CancerCare-Eureka

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Evanston

NorthShore University HealthSystem-Evanston Hospital

Ryan Thomas Merrell
Ph: 847-570-2109

Ryan Thomas Merrell
Principal Investigator

Galesburg

Illinois CancerCare-Galesburg

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Glenview

NorthShore University HealthSystem-Glenbrook Hospital

Ryan Thomas Merrell
Ph: 847-570-2109

Ryan Thomas Merrell
Principal Investigator

Highland Park

NorthShore University HealthSystem-Highland Park Hospital

Ryan Thomas Merrell
Ph: 847-570-2109

Ryan Thomas Merrell
Principal Investigator

Kewanee

Illinois CancerCare-Kewanee Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Macomb

Illinois CancerCare-Macomb

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Moline

Trinity Medical Center

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Ottawa

Illinois CancerCare-Ottawa Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Pekin

Illinois CancerCare-Pekin

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Peoria

Illinois CancerCare-Peoria

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Methodist Medical Center of Illinois

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

OSF Saint Francis Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Peru

Illinois CancerCare-Peru

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Princeton

Illinois CancerCare-Princeton

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Springfield

Memorial Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Southern Illinois University School of Medicine

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Springfield Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Urbana

Carle Cancer Center

Maria T. Grosse-Perdekamp
Ph: 800-446-5532

Maria T. Grosse-Perdekamp
Principal Investigator

Warrenville

Northwestern Medicine Cancer Center Warrenville

Sean A. Grimm
Ph: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org

Sean A. Grimm
Principal Investigator

Indiana
Mishawaka

Memorial Regional Cancer Center Day Road

Thomas Joseph Reid
Ph: 800-284-7370

Thomas Joseph Reid
Principal Investigator

South Bend

Memorial Hospital of South Bend

Thomas Joseph Reid
Ph: 800-284-7370

Thomas Joseph Reid
Principal Investigator

Northern Indiana Cancer Research Consortium

Robin T. Zon
Ph: 574-234-5123

Robin T. Zon
Principal Investigator

Iowa
Cedar Rapids

Mercy Hospital

Deborah Weil Wilbur
Ph: 515-241-3305

Deborah Weil Wilbur
Principal Investigator

Oncology Associates at Mercy Medical Center

Deborah Weil Wilbur
Ph: 515-241-3305

Deborah Weil Wilbur
Principal Investigator

Clive

Medical Oncology and Hematology Associates-West Des Moines

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Mercy Cancer Center-West Lakes

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Creston

Greater Regional Medical Center

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Des Moines

Medical Oncology and Hematology Associates-Laurel

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Mercy Medical Center - Des Moines

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Mason City

Mercy Medical Center - North Iowa

Joginder (Joe) Singh
Ph: 800-433-3883

Joginder (Joe) Singh
Principal Investigator

Sioux City

Siouxland Regional Cancer Center

Donald B. Wender
Ph: 712-252-0088

Donald B. Wender
Principal Investigator

West Des Moines

Mercy Medical Center-West Lakes

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Kansas
Chanute

Cancer Center of Kansas - Chanute

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Dodge City

Cancer Center of Kansas - Dodge City

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

El Dorado

Cancer Center of Kansas - El Dorado

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Fort Scott

Cancer Center of Kansas - Fort Scott

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Independence

Cancer Center of Kansas-Independence

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Kingman

Cancer Center of Kansas-Kingman

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Lawrence

Lawrence Memorial Hospital

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Liberal

Cancer Center of Kansas-Liberal

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Newton

Cancer Center of Kansas - Newton

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Parsons

Cancer Center of Kansas - Parsons

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Pratt

Cancer Center of Kansas - Pratt

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Salina

Cancer Center of Kansas - Salina

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Wellington

Cancer Center of Kansas - Wellington

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Wichita

Associates In Womens Health

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas - Wichita

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas-Wichita Medical Arts Tower

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Via Christi Regional Medical Center

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Winfield

Cancer Center of Kansas - Winfield

Shaker R. Dakhil
Ph: 316-268-5374

Shaker R. Dakhil
Principal Investigator

Kentucky
Corbin

Baptist Health Corbin

Firas B. Badin
Ph: 859-260-6425

Firas B. Badin
Principal Investigator

Elizabethtown

Hardin Memorial Hospital

Firas B. Badin
Ph: 859-260-6425

Firas B. Badin
Principal Investigator

Lexington

Baptist Health Lexington

Firas B. Badin
Ph: 859-260-6425

Firas B. Badin
Principal Investigator

University of Kentucky/Markey Cancer Center

John Lee Villano
Ph: 859-257-3379

John Lee Villano
Principal Investigator

Louisville

Baptist Health Louisville

Firas B. Badin
Ph: 859-260-6425

Firas B. Badin
Principal Investigator

Madisonville

Baptist Health Madisonville/Merle Mahr Cancer Center

Firas B. Badin
Ph: 859-260-6425

Firas B. Badin
Principal Investigator

Paducah

Baptist Health Paducah

Firas B. Badin
Ph: 859-260-6425

Firas B. Badin
Principal Investigator

Louisiana
Baton Rouge

The NeuroMedical Center-Clinic

Augusto C. Ochoa
Ph: 504-568-2428
Email: emede1@lsuhsc.edu

Augusto C. Ochoa
Principal Investigator

Maine
Lewiston

Central Maine Medical Center

Daniel Cary Rausch
Ph: 207-795-8250
Email: benderli@cmhc.org

Daniel Cary Rausch
Principal Investigator

Maryland
Rockville

Unspecified Site

Alyx B. Porter Umphrey
Ph: 507-266-5230
Email: porter.alyx@mayo.edu

Alyx B. Porter Umphrey
Principal Investigator

Massachusetts
Boston

Tufts Medical Center

Suriya Jeyapalan
Ph: 617-636-5000
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

Suriya Jeyapalan
Principal Investigator

Michigan
Ann Arbor

Saint Joseph Mercy Hospital

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Battle Creek

Bronson Battle Creek

Kathleen J. Yost
Ph: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Kathleen J. Yost
Principal Investigator

Detroit

Saint John Hospital and Medical Center

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Grand Rapids

Mercy Health Saint Mary's

Kathleen J. Yost
Ph: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Kathleen J. Yost
Principal Investigator

Spectrum Health at Butterworth Campus

Kathleen J. Yost
Ph: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Kathleen J. Yost
Principal Investigator

Kalamazoo

West Michigan Cancer Center

Kathleen J. Yost
Ph: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Kathleen J. Yost
Principal Investigator

Marquette

Marquette General Hematology Oncology

Philip Andrew Lowry
Ph: 508-856-3216
Email: cancer.research@umassmed.edu

Philip Andrew Lowry
Principal Investigator

Marquette General Hospital

Philip Andrew Lowry
Ph: 508-856-3216
Email: cancer.research@umassmed.edu

Philip Andrew Lowry
Principal Investigator

Royal Oak

William Beaumont Hospital-Royal Oak

John M. Robertson
Ph: 248-551-7695

John M. Robertson
Principal Investigator

Saginaw

Saint Mary's of Michigan

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Southfield

Providence Hospital-Southfield Cancer Center

Susan Elizabeth Lyons
Ph: 248-849-5337
Email: jaswinder.grewal@stjohn.org

Susan Elizabeth Lyons
Principal Investigator

Troy

William Beaumont Hospital - Troy

John M. Robertson
Ph: 248-551-7695

John M. Robertson
Principal Investigator

Warren

Saint John Macomb-Oakland Hospital

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Minnesota
Burnsville

Fairview Ridges Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Coon Rapids

Mercy Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Duluth

Essentia Health Cancer Center

Bret E.B. Friday
Ph: 888-203-7267

Bret E.B. Friday
Principal Investigator

Edina

Fairview-Southdale Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Fridley

Unity Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Maplewood

Minnesota Oncology Hematology PA-Maplewood

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Saint John's Hospital - Healtheast

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Minneapolis

Abbott-Northwestern Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Health Partners Inc

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Hennepin County Medical Center

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Robbinsdale

North Memorial Medical Health Center

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Rochester

Mayo Clinic

Alyx B. Porter Umphrey
Ph: 855-776-0015

Alyx B. Porter Umphrey
Principal Investigator

Saint Louis Park

Park Nicollet Clinic - Saint Louis Park

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Saint Paul

Regions Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

United Hospital

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Woodbury

Minnesota Oncology Hematology PA-Woodbury

Joseph W. Leach
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Joseph W. Leach
Principal Investigator

Missouri
Bolivar

Central Care Cancer Center-Carrie J Babb Cancer Center

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Chesterfield

Saint Luke's Hospital

Donald F. Busiek
Ph: 314-205-6936

Donald F. Busiek
Principal Investigator

Joplin

Freeman Health System

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Kansas City

Saint Luke's Hospital of Kansas City

Rakesh Gaur
Ph: 913-948-5588
Email: aroland@kccop.org

Rakesh Gaur
Principal Investigator

Saint Louis

Washington University School of Medicine

Jian Li Campian
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Jian Li Campian
Principal Investigator

Springfield

Mercy Hospital Springfield

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Montana
Billings

Billings Clinic Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Montana Cancer Consortium NCORP

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Great Falls

Benefis Healthcare- Sletten Cancer Institute

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Nebraska
Kearney

CHI Health Good Samaritan

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Lincoln

Nebraska Cancer Research Center

Gamini S. Soori
Ph: 402-393-3110

Gamini S. Soori
Principal Investigator

Omaha

Alegent Health Lakeside Hospital

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Creighton University Medical Center

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Nevada
Las Vegas

Nevada Cancer Research Foundation CCOP

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

New Hampshire
Concord

New Hampshire Oncology Hematology PA-Concord

Douglas J. Weckstein
Ph: 603-224-2556

Douglas J. Weckstein
Principal Investigator

Hooksett

New Hampshire Oncology Hematology PA-Hooksett

Douglas J. Weckstein
Ph: 603-224-2556

Douglas J. Weckstein
Principal Investigator

Lebanon

Dartmouth Hitchcock Medical Center

Paula K. Rauschkolb
Ph: 217-545-7929

Paula K. Rauschkolb
Principal Investigator

New York
East Syracuse

Hematology Oncology Associates of Central New York-East Syracuse

Jeffrey J. Kirshner
Ph: 315-472-7504

Jeffrey J. Kirshner
Principal Investigator

Rochester

Highland Hospital

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

University of Rochester

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

University Radiation Oncology

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

North Carolina
Clinton

Southeastern Medical Oncology Center-Clinton

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Goldsboro

Southeastern Medical Oncology Center-Goldsboro

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Wayne Memorial Hospital

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Jacksonville

Southeastern Medical Oncology Center-Jacksonville

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Kinston

Kinston Medical Specialists PA

Peter Robins Watson
Ph: 252-559-2200

Peter Robins Watson
Principal Investigator

Wilson

Southeastern Medical Oncology Center-Wilson

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

North Dakota
Grand Forks

Altru Cancer Center

Grant Richard Seeger
Ph: 701-780-6520

Grant Richard Seeger
Principal Investigator

Ohio
Akron

Akron General Medical Center

Esther Hoogland Rehmus
Ph: 330-344-6348

Esther Hoogland Rehmus
Principal Investigator

Columbus

Riverside Methodist Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Maumee

Toledo Clinic Cancer Centers-Maumee

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Oregon

Saint Charles Hospital

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Toledo

Mercy Saint Anne Hospital

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Toledo Clinic Cancer Centers-Toledo

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

University of Toledo

Krishna Reddy
Ph: 419-383-6583

Krishna Reddy
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

James Douglas Battiste
Ph: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

James Douglas Battiste
Principal Investigator

Oregon
Clackamas

Clackamas Radiation Oncology Center

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Gresham

Legacy Mount Hood Medical Center

Regan Mon Look
Ph: 503-280-1223

Regan Mon Look
Principal Investigator

Newberg

Providence Newberg Medical Center

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Oregon City

Providence Willamette Falls Medical Center

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Portland

Kaiser Permanente Northwest

Sandeep Hashmukh Mashru
Ph: 503-335-2400

Sandeep Hashmukh Mashru
Principal Investigator

Legacy Good Samaritan Hospital and Medical Center

Regan Mon Look
Ph: 503-280-1223

Regan Mon Look
Principal Investigator

Providence Portland Medical Center

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Providence Saint Vincent Medical Center

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Tualatin

Legacy Meridian Park Hospital

Regan Mon Look
Ph: 503-280-1223

Regan Mon Look
Principal Investigator

Pennsylvania
Allentown

Lehigh Valley Hospital-Cedar Crest

Suresh G. Nair
Ph: 610-402-2273

Suresh G. Nair
Principal Investigator

Danville

Geisinger Medical Center

Scott G. Turner
Ph: 570-271-5251

Scott G. Turner
Principal Investigator

Wilkes-Barre

Geisinger Wyoming Valley/Henry Cancer Center

Scott G. Turner
Ph: 570-271-5251

Scott G. Turner
Principal Investigator

South Carolina
Easley

Greenville Health System Cancer Institute-Easley

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Gaffney

Gibbs Cancer Center-Gaffney

James Dewitt Bearden
Ph: 800-486-5941

James Dewitt Bearden
Principal Investigator

Greenville

Greenville Health System Cancer Institute-Butternut

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greenville Health System Cancer Institute-Eastside

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greenville Health System Cancer Institute-Faris

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greer

Gibbs Cancer Center-Pelham

James Dewitt Bearden
Ph: 800-486-5941

James Dewitt Bearden
Principal Investigator

Greenville Health System Cancer Institute-Greer

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Seneca

Greenville Health System Cancer Institute-Seneca

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Spartanburg

Greenville Health System Cancer Institute-Spartanburg

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Spartanburg Medical Center

James Dewitt Bearden
Ph: 800-486-5941

James Dewitt Bearden
Principal Investigator

South Dakota
Aberdeen

Avera Cancer Institute-Aberdeen

Amy K. Krie
Ph: 888-634-7268
Email: oncregulatory@avera.org

Amy K. Krie
Principal Investigator

Rapid City

Rapid City Regional Hospital

Joshua Cole Lukenbill
Ph: 605-716-3982
Email: research@rcrh.org

Joshua Cole Lukenbill
Principal Investigator

Sioux Falls

Avera Cancer Institute

Amy K. Krie
Ph: 888-634-7268
Email: oncregulatory@avera.org

Amy K. Krie
Principal Investigator

Texas
Austin

Austin Cancer Centers-Central Austin

Brian David Vaillant
Ph: 952-993-1517

Brian David Vaillant
Principal Investigator

Austin Cancer Centers-North

Brian David Vaillant
Ph: 952-993-1517

Brian David Vaillant
Principal Investigator

University Medical Center Brackenridge

Brian David Vaillant
Ph: 952-993-1517

Brian David Vaillant
Principal Investigator

San Antonio

University of Texas Health Science Center at San Antonio

Andrew Jacob Brenner
Ph: 210-450-3800

Andrew Jacob Brenner
Principal Investigator

Washington
Aberdeen

Providence Regional Cancer System-Aberdeen

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Auburn

MultiCare Auburn Medical Center

John A. Keech
Ph: 253-403-2394

John A. Keech
Principal Investigator

Bellingham

PeaceHealth Saint Joseph Medical Center

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Burien

Highline Medical Center-Main Campus

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Centralia

Providence Regional Cancer System-Centralia

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Gig Harbor

MultiCare Gig Harbor Medical Park

John A. Keech
Ph: 253-403-2394

John A. Keech
Principal Investigator

Lacey

Providence Regional Cancer System-Lacey

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Longview

PeaceHealth Saint John Medical Center

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Puyallup

MultiCare Good Samaritan Hospital

John A. Keech
Ph: 253-403-2394

John A. Keech
Principal Investigator

Shelton

Providence Regional Cancer System-Shelton

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Tacoma

Multicare Health System

John A. Keech
Ph: 253-403-2394

John A. Keech
Principal Investigator

MultiCare Tacoma General Hospital

John A. Keech
Ph: 253-403-2394

John A. Keech
Principal Investigator

Vancouver

Legacy Salmon Creek Hospital

Regan Mon Look
Ph: 503-280-1223

Regan Mon Look
Principal Investigator

PeaceHealth Southwest Medical Center

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

Yelm

Providence Regional Cancer System-Yelm

Keith S. Lanier
Ph: 503-215-2614
Email: CanRsrchStudies@providence.org

Keith S. Lanier
Principal Investigator

West Virginia
Morgantown

West Virginia University Healthcare

Javier Gonzalez
Ph: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu

Javier Gonzalez
Principal Investigator

Wisconsin
Green Bay

Aurora BayCare Medical Center

George Corneliu Bobustuc
Ph: 414-649-5717

George Corneliu Bobustuc
Principal Investigator

Green Bay Oncology at Saint Vincent Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Green Bay Oncology Limited at Saint Mary's Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Saint Vincent Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

La Crosse

Gundersen Lutheran Medical Center

Michael O Ojelabi
Ph: 608-775-2385
Email: cancerctr@gundersenhealth.org

Michael O Ojelabi
Principal Investigator

Manitowoc

Holy Family Memorial Hospital

Anthony John Jaslowski
Ph: 800-432-6049

Anthony John Jaslowski
Principal Investigator

Milwaukee

Aurora Saint Luke's Medical Center

George Corneliu Bobustuc
Ph: 414-649-5717

George Corneliu Bobustuc
Principal Investigator

Mukwonago

D N Greenwald Center

Timothy Robert Wassenaar
Ph: 262-928-5539
Email: Chanda.miller@phci.org

Timothy Robert Wassenaar
Principal Investigator

Oconomowoc

Oconomowoc Memorial Hospital-ProHealth Care Inc

Timothy Robert Wassenaar
Ph: 262-928-5539
Email: Chanda.miller@phci.org

Timothy Robert Wassenaar
Principal Investigator

Waukesha

UW Cancer Center at ProHealth Care

Timothy Robert Wassenaar
Ph: 262-928-5539
Email: Chanda.miller@phci.org

Timothy Robert Wassenaar
Principal Investigator

Waukesha Memorial Hospital

Timothy Robert Wassenaar
Ph: 262-928-5539
Email: Chanda.miller@phci.org

Timothy Robert Wassenaar
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01781468

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.