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Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil (Remember)

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ClinicalTrials.gov Identifier: NCT02822573
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
This study is to compare the safety and effects of donepezil (Aricept) for patients reporting cognitive or memory issues after receiving chemotherapy for breast cancer. Patients will receive either donepezil or placebo for 24 weeks. The primary objective is to see if memory improves with the use of donepezil during the study.

Condition or disease Intervention/treatment Phase
Cognitive Dysfunction Memory Impairment Drug: Donepezil 5 mg Drug: Placebo Phase 3

Detailed Description:

Randomized, double-blind, placebo-controlled study with 24 weeks of exposure to drug or placebo followed by a 12 week wash-out period. Patients who meet the eligibility criteria will be stratified by age (<50, 50-59, 60-69, ≥70) and randomized to donepezil or placebo with equal probability. A total of 276 patients will be enrolled (138 per arm). We expect an accrual rate of 7-10 participants per month based on our prior feasibility study. We expect the study to be complete within 40 months.

Participants will be asked to take one 5mg tablet of donepezil or one tablet of matching placebo orally once a day for 6 weeks followed by two 5mg tablets (10mg total) of donepezil or two placebo tablets orally once a day for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Time points for performing study assessments. Participants will be administered the cognitive battery of tests and questionnaires at baseline, week 12, week 24 and week 36. In addition, a single vial of blood will be drawn at baseline for APOE genotyping and subsequent bioassays (pending supplemental funding).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil in Chemotherapy Exposed Breast Cancer Survivors With Cognitive Impairment
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : October 12, 2020
Estimated Study Completion Date : October 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: Donepezil
Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5 mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
Drug: Donepezil 5 mg
Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
Other Name: Aricept

Placebo Comparator: Placebo
Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
Drug: Placebo
Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
Other Name: Sugar Pill




Primary Outcome Measures :
  1. Changes in Hopkins Verbal Learning Test-Revised (HVLT-R) Results [ Time Frame: Baseline and Week 24 ]
    The HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R.


Secondary Outcome Measures :
  1. Changes in Digit Symbol Coding Results [ Time Frame: Baseline and Week 24 ]
    The DSC test measures processing speed. It requires respondents to transcribe symbols (e.g., >) associated with a number (0-9) into empty boxes beneath a series of randomly ordered numbers. Total score is number of correctly transcribed symbols in 2 minutes. Scores range from 0-133.

  2. Changes in PROMIS 7-item Fatigue Scale Results [ Time Frame: Baseline and Week 24 ]
    This self-report scale assesses fatigue. Scale ranges from 7 to 35, with higher scores representing more fatigue.

  3. Changes in FACT-Cognition (Version 3) Results [ Time Frame: Baseline and Week 24 ]
    This is a validated self-report questionnaire that assesses patients' perceptions of their cognitive function and the impact of cognitive problems on overall quality of life over the prior 7 days. Higher scores reflect better cognitive functioning and less impairment.

  4. Changes in Controlled Oral Word Association Test (COWA) Results [ Time Frame: Baseline and Week 24 ]
    The COWA measures speed of mental processing, verbal fluency, and executive function. Subjects are asked to name as many words as possible all beginning with a specified letter. A total of three trials are administered, each with a different letter (F-A-S). The score on the COWA is the total number of words named across the three trials minus repetitions.

  5. Changes in Trail Making Test, Parts A & B (TMT-A, TMT-B) Results [ Time Frame: Baseline and Week 24 ]
    Part A of the TMT measures attention and visual motor skills and processing speed and requires subjects to connect 25 numbered circles in the proper sequence (1-2-3-…) as quickly as possible. TMT-B is similar except subjects are required to connect dots in an alternating numerical and alphabetical sequence (1-A-2-B-…). TMT-B with its added complexity and set shifting requirements is a widely used measure of executive function. The score for TMT-A and TMT-B is the total time in seconds required to complete the task. Scores can also be generated for number of errors and number of circles correctly connected.

  6. Digit Span Test-Backwards (DST-B) [ Time Frame: Baseline and Week 24 ]
    The DST-B assesses attention and working memory. It requires respondents to repeat back in reverse order spans of numbers. Seven pairs of spans of increasing lengths are presented and repeated. A total score is the number of correctly repeated spans.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women ≥18 years old with history of invasive breast cancer
  • Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to registration (Ongoing herceptin or other chronic HER 2 directed therapies are allowed).
  • Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study registration and plan to continue for the duration of the study (9 months)
  • Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted (patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet) if dose is stable over previous 12 weeks. Patients who were previously on one of these psychotropic medications and have subsequently discontinued the drug must have been off the medication for at least 4 weeks prior to enrollment. Patients who have been on a psychotropic medication for at least 12 weeks but have recently switched to a medicine in the same class (for example, switching from one SSRI antidepressant to a different SSRI antidepressant) need to be on a stable dose of the new medication for at least 4 weeks prior to enrollment to be eligible.
  • Self-reported cognitive problem plus a measured memory deficit (score <7 on single trial of Eligibility Pre-screen HVLT-R Form 3).
  • ECOG performance status 0-2
  • Ability to understand and the willingness to sign a written informed consent document.
  • Must be able to speak English.
  • Patients currently taking a moderate risk QTc prolongation medication (see Appendix A) are allowed if one of the following criteria are met: 1) The moderate risk QTc prolongation medication is stopped. The patient should be off the moderate risk QTc prolongation medication for at least 5 half-lives before starting study drug. 2) Patients that continue using a moderate risk QTc prolongation medication must have a normal QTc interval (≤ 460 milliseconds) on a screening ECG following informed consent and prior to study enrollment. These patients will also be monitored at designated study follow-up visits per Section 7.5 (monitored 3-7 days after initiating study drug, at week 3, and 3-7 days after the study drug dose increase with ECG's to assess the QTc interval; the QTc level must be ≤ 500 milliseconds at these time points in order to continue on the study drug). 3) Moderate risk QTc prolongation medications that are only taken occasionally may be stopped at the discretion of the treating site physician. Patients must be off medication for at least 5 half-lives prior to starting study drug to be eligible.
  • Patients currently taking a moderate risk bradycardia-causing agent (see Appendix B) are allowed if one of the following criteria are met: 1) The moderate risk bradycardia-causing agent is stopped. The patient should be off the moderate risk bradycardia-causing agent for at least 5 half-lives before starting study drug. 2) Patients that continue using a moderate risk bradycardia-causing agent must have a resting heart rate ≥ 55 beats per minute at screening following informed consent. These patients' resting heart rate will be monitored 3-7 days after initiating study drug, at week 3, and 3-7 days after the study drug dose increase per Section 7.5. 3) Moderate risk bradycardia-causing agents that are only taken occasionally may be stopped at the discretion of the treating site physician. Patients must be off medication for at least 5 half-lives prior to starting study drug to be eligible.

Exclusion Criteria:

  • Evidence or suspected recurrent or metastatic disease.
  • Prior brain irradiation is not allowed.
  • Planned therapy (surgery, radiation, chemotherapy, or immunotherapy) while on the study for brain and/or extracranial primary/metastatic disease.
  • Hypersensitivity to donepezil or piperidine derivatives
  • Current use of ceritinib
  • Current use of Succinylcholine/Acetylcholinesterase Inhibitors(as listed in Appendix C). For patients who have used these medications, they must not have used them within 4 weeks prior to enrollment.
  • Current use of high-risk QTc prolonging medication(s). See Appendix D
  • Current use of quinidine or systemic ketoconazole (topical ketoconazole is acceptable to use while on study).
  • History of dementia, Alzheimer's disease, multi-infarct dementia or clinically significant Cerebrovascular Accident (history of transient ischemic attack (TIA) is allowed).
  • Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drug(s). For patients who have used these medications, they must not have used them within 4 weeks prior to pre-screening. Patients who plan to start taking a cognition enhancing drug while on this study are also excluded.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to donepezil. Hypersensitivity to donepezil.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia.
  • Major medical conditions that affect cognition, traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia.
  • Psychiatric illness/social situations that would limit compliance with study requirements including but not limited to a history of schizophrenia, psychosis or substance abuse.
  • Untreated current severe depression. Currently treated depression is permitted if treatment is stable.
  • Patients with a resting heart rate less than 55 beats per minute, seizure disorder or peptic ulcer disease (PUD).
  • History of congenital long QT syndrome or torsades de pointes.
  • Screening QTc of > 460 milliseconds will make the patient ineligible.
  • Pregnant women are excluded from this study. Following informed consent, women of child-bearing potential will be screened with a serum or urine pregnancy test within 10 days of enrollment. The effects of donepezil on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because donepezil is known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.
  • It is unknown whether donepezil is excreted in breast milk, for this reason women who are currently breast-feeding are not eligible for this study.
  • On another intervention study involving medication at the time of enrollment or during participation in this study. (Exception: Patients will remain eligible for this study if they are also enrolled on the Alliance for Clinical Trials in Oncology study (NCT02927249): Aspirin in Preventing Recurrence of Cancer in Patients with HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy. Studies that involve only blood draws or questionnaires are also permitted.)
  • Use of investigational drugs likely to affect cognition within 30 days prior to pre-screening visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822573


Contacts
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Contact: Karen Craver (336) 716-0891 NCORP@wakehealth.edu

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Locations
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United States, California
Kaiser Permanente-Anaheim Recruiting
Anaheim, California, United States, 92806
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
Kaiser Permanente-Deer Valley Medical Center Recruiting
Antioch, California, United States, 94531
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-Baldwin Park Recruiting
Baldwin Park, California, United States, 91706
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
Kaiser Permanente-Bellflower Recruiting
Bellflower, California, United States, 90706
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
Kaiser Permanente-Fontana Recruiting
Fontana, California, United States, 92335
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
Kaiser Permanente-Fremont Recruiting
Fremont, California, United States, 94538
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-Fresno Recruiting
Fresno, California, United States, 93720
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente - Harbor City Recruiting
Harbor City, California, United States, 90710
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
Kaiser Permanente-Irvine Recruiting
Irvine, California, United States, 92618
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
Kaiser Permanente Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90027
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
Kaiser Permanente-Cadillac Recruiting
Los Angeles, California, United States, 90034
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
Kaiser Permanente-Modesto Recruiting
Modesto, California, United States, 95356
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente - Panorama City Recruiting
Panorama City, California, United States, 91402
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
Kaiser Permanente-Rancho Cordova Cancer Center Recruiting
Rancho Cordova, California, United States, 95670
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-Richmond Recruiting
Richmond, California, United States, 94801
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-Riverside Recruiting
Riverside, California, United States, 92505
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
Kaiser Permanente-Roseville Recruiting
Roseville, California, United States, 95661
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
The Permanente Medical Group-Roseville Radiation Oncology Recruiting
Roseville, California, United States, 95678
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente Downtown Commons Recruiting
Sacramento, California, United States, 95814
Contact: Site Public Contact    877-642-4691    kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-South Sacramento Recruiting
Sacramento, California, United States, 95823
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
South Sacramento Cancer Center Recruiting
Sacramento, California, United States, 95823
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente - Sacramento Recruiting
Sacramento, California, United States, 95825
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-San Diego Zion Recruiting
San Diego, California, United States, 92120
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
Kaiser Permanente-San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-Santa Teresa-San Jose Recruiting
San Jose, California, United States, 95119
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente San Leandro Recruiting
San Leandro, California, United States, 94577
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-San Marcos Recruiting
San Marcos, California, United States, 92078
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
Kaiser Permanente-San Rafael Recruiting
San Rafael, California, United States, 94903
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser San Rafael-Gallinas Recruiting
San Rafael, California, United States, 94903
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente Medical Center - Santa Clara Recruiting
Santa Clara, California, United States, 95051
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-Santa Rosa Recruiting
Santa Rosa, California, United States, 95403
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-South San Francisco Recruiting
South San Francisco, California, United States, 94080
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-Stockton Recruiting
Stockton, California, United States, 95210
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente Medical Center-Vacaville Recruiting
Vacaville, California, United States, 95688
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-Vallejo Recruiting
Vallejo, California, United States, 94589
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-Walnut Creek Recruiting
Walnut Creek, California, United States, 94596
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Samantha A. Seaward         
Kaiser Permanente-Woodland Hills Recruiting
Woodland Hills, California, United States, 91367
Contact: Site Public Contact    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Jonathan A. Polikoff         
United States, Colorado
Kaiser Permanente-Franklin Recruiting
Denver, Colorado, United States, 80205
Contact: Site Public Contact    303-764-5056    josh.b.gordon@nsmtp.kp.org   
Principal Investigator: Alexander Menter         
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Kaiser Permanente-Rock Creek Recruiting
Lafayette, Colorado, United States, 80026
Contact: Site Public Contact    303-764-5056    josh.b.gordon@nsmtp.kp.org   
Principal Investigator: Alexander Menter         
Littleton Adventist Hospital Recruiting
Littleton, Colorado, United States, 80122
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Kaiser Permanente-Lone Tree Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Site Public Contact    303-764-5056    josh.b.gordon@nsmtp.kp.org   
Principal Investigator: Alexander Menter         
Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Parker Adventist Hospital Recruiting
Parker, Colorado, United States, 80138
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
United States, Delaware
Helen F Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Medical Oncology Hematology Consultants PA Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Regional Hematology and Oncology PA Suspended
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Beebe Health Campus Recruiting
Rehoboth Beach, Delaware, United States, 19971
Contact: Site Public Contact    302-645-3100    Dmiskin@Beebehealthcare.org   
Principal Investigator: Gregory A. Masters         
Nanticoke Memorial Hospital Recruiting
Seaford, Delaware, United States, 19973
Contact: Site Public Contact    302-645-3100    Dmiskin@Beebehealthcare.org   
Principal Investigator: Gregory A. Masters         
United States, Hawaii
Pali Momi Medical Center Recruiting
'Aiea, Hawaii, United States, 96701
Contact: Site Public Contact    808-486-6000      
Principal Investigator: Jeffrey L. Berenberg         
Hawaii Cancer Care Inc-POB II Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-524-6115      
Principal Investigator: Jeffrey L. Berenberg         
Hawaii Oncology Inc-POB I Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-532-0315      
Principal Investigator: Jeffrey L. Berenberg         
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-522-4333      
Principal Investigator: Jeffrey L. Berenberg         
University of Hawaii Cancer Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Hawaii Cancer Care Inc-Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Site Public Contact    808-536-4888      
Principal Investigator: Jeffrey L. Berenberg         
Hawaii Oncology Inc-Kuakini Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Site Public Contact    808-531-8521      
Principal Investigator: Jeffrey L. Berenberg         
Kaiser Permanente Moanalua Medical Center Recruiting
Honolulu, Hawaii, United States, 96819
Contact: Site Public Contact    808-432-5195    shelley.a.clark@kp.org   
Principal Investigator: Samantha A. Seaward         
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Site Public Contact    808-983-6090      
Principal Investigator: Jeffrey L. Berenberg         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Alison K. Conlin         
Saint Luke's Mountain States Tumor Institute - Fruitland Recruiting
Fruitland, Idaho, United States, 83619
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Alison K. Conlin         
Saint Luke's Mountain States Tumor Institute - Meridian Recruiting
Meridian, Idaho, United States, 83642
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Alison K. Conlin         
Saint Luke's Mountain States Tumor Institute - Nampa Recruiting
Nampa, Idaho, United States, 83686
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Alison K. Conlin         
Saint Luke's Mountain States Tumor Institute-Twin Falls Recruiting
Twin Falls, Idaho, United States, 83301
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Alison K. Conlin         
United States, Illinois
Illinois CancerCare-Bloomington Recruiting
Bloomington, Illinois, United States, 61704
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Centralia Oncology Clinic Recruiting
Centralia, Illinois, United States, 62801
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Carle on Vermilion Recruiting
Danville, Illinois, United States, 61832
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Pratima Chalasani         
Cancer Care Specialists of Illinois - Decatur Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740      
Principal Investigator: Bryan A. Faller         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Carle Physician Group-Effingham Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Pratima Chalasani         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Carle Physician Group-Mattoon/Charleston Recruiting
Mattoon, Illinois, United States, 61938
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Pratima Chalasani         
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Pekin Recruiting
Pekin, Illinois, United States, 61554
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Pratima Chalasani         
The Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Pratima Chalasani         
United States, Iowa
Physicians' Clinic of Iowa PC Recruiting
Cedar Rapids, Iowa, United States, 52402
Contact: Site Public Contact    319-297-2900    cetscheidt@pcofiowa.com   
Principal Investigator: William P. Fusselman         
Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact    515-241-6727      
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates-Des Moines Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact    515-282-2921      
Principal Investigator: Robert J. Behrens         
Broadlawns Medical Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Site Public Contact    515-282-2200      
Principal Investigator: Robert J. Behrens         
Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Iowa Lutheran Hospital Recruiting
Des Moines, Iowa, United States, 50316
Contact: Site Public Contact    515-241-8704      
Principal Investigator: Robert J. Behrens         
Methodist West Hospital Recruiting
West Des Moines, Iowa, United States, 50266-7700
Contact: Site Public Contact    515-343-1000      
Principal Investigator: Robert J. Behrens         
United States, Kansas
Cancer Center of Kansas - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Fort Scott Suspended
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Manhattan Recruiting
Manhattan, Kansas, United States, 66502
Contact: Site Public Contact    316-268-5784    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - McPherson Recruiting
McPherson, Kansas, United States, 67460
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Associates In Womens Health Recruiting
Wichita, Kansas, United States, 67208
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Wichita Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Site Public Contact    800-362-0070    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
United States, Kentucky
Flaget Memorial Hospital Recruiting
Bardstown, Kentucky, United States, 40004
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Saint Joseph Radiation Oncology Resource Center Recruiting
Lexington, Kentucky, United States, 40504
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Saint Joseph Hospital East Recruiting
Lexington, Kentucky, United States, 40509
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Saint Joseph London Recruiting
London, Kentucky, United States, 40741
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
United States, Louisiana
Christus Saint Frances Cabrini Hospital Active, not recruiting
Alexandria, Louisiana, United States, 71301
LSU Health Baton Rouge-North Clinic Recruiting
Baton Rouge, Louisiana, United States, 70805
Contact: Site Public Contact    225-215-1353    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
Louisiana Hematology Oncology Associates LLC Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Site Public Contact    225-215-1353    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
Mary Bird Perkins Cancer Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Site Public Contact    225-215-1353    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
Our Lady of the Lake Physicians Group - Medical Oncology Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Site Public Contact    225-757-0343    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Site Public Contact    504-703-8712    Gregory.Johnstone@ochsner.org   
Principal Investigator: John T. Cole         
CHRISTUS Highland Medical Center Recruiting
Shreveport, Louisiana, United States, 71105
Contact: Site Public Contact    318-681-4763    Nancy.hassan@christushealth.org   
Principal Investigator: John T. Cole         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Saint Joseph Mercy Brighton Recruiting
Brighton, Michigan, United States, 48114
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Saint Joseph Mercy Canton Recruiting
Canton, Michigan, United States, 48188
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Caro Cancer Center Recruiting
Caro, Michigan, United States, 48723
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Saint Joseph Mercy Chelsea Recruiting
Chelsea, Michigan, United States, 48118
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Hematology Oncology Consultants-Clarkston Recruiting
Clarkston, Michigan, United States, 48346
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Newland Medical Associates-Clarkston Recruiting
Clarkston, Michigan, United States, 48346
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Beaumont Hospital ? Dearborn Recruiting
Dearborn, Michigan, United States, 48124
Contact: Site Public Contact    313-593-8090      
Principal Investigator: Deepa B. Jagtap         
Green Bay Oncology - Escanaba Recruiting
Escanaba, Michigan, United States, 49829
Contact: Site Public Contact    920-433-8889    Christy.Gilchrist@hshs.org   
Principal Investigator: Anthony J. Jaslowski         
Beaumont Hospital - Farmington Hills Recruiting
Farmington Hills, Michigan, United States, 48336
Contact: Site Public Contact    248-551-7695      
Principal Investigator: Deepa B. Jagtap         
Genesee Cancer and Blood Disease Treatment Center Recruiting
Flint, Michigan, United States, 48503
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Genesee Hematology Oncology PC Recruiting
Flint, Michigan, United States, 48503
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Mercy Health Saint Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Kathleen J. Yost         
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
William Beaumont Hospital-Grosse Point Recruiting
Grosse Pointe, Michigan, United States, 48230
Contact: Site Public Contact    248-551-7695      
Principal Investigator: Deepa B. Jagtap         
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Mercy Health Mercy Campus Recruiting
Muskegon, Michigan, United States, 49444
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Newland Medical Associates-Pontiac Recruiting
Pontiac, Michigan, United States, 48341
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Spectrum Health Reed City Hospital Recruiting
Reed City, Michigan, United States, 49677
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
William Beaumont Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Site Public Contact    248-551-7695      
Principal Investigator: Deepa B. Jagtap         
Ascension Saint Mary's Hospital Recruiting
Saginaw, Michigan, United States, 48601
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Tareq Al Baghdadi         
Oncology Hematology Associates of Saginaw Valley PC Recruiting
Saginaw, Michigan, United States, 48604
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Ascension Saint Joseph Hospital Recruiting
Tawas City, Michigan, United States, 48764
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
William Beaumont Hospital - Troy Recruiting
Troy, Michigan, United States, 48085
Contact: Site Public Contact    248-551-7695      
Principal Investigator: Deepa B. Jagtap         
Saint Mary's Oncology/Hematology Associates of West Branch Recruiting
West Branch, Michigan, United States, 48661
Contact: Site Public Contact    989-343-2487      
Principal Investigator: Tareq Al Baghdadi         
Metro Health Hospital Recruiting
Wyoming, Michigan, United States, 49519
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Fairview Maple Grove Medical Center Recruiting
Maple Grove, Minnesota, United States, 55369
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Minnesota Oncology Hematology PA-Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Saint John's Hospital - Healtheast Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Pamala A. Pawloski         
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Health Partners Inc Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
New Ulm Medical Center Recruiting
New Ulm, Minnesota, United States, 56073
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
North Memorial Medical Health Center Recruiting
Robbinsdale, Minnesota, United States, 55422
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Saint Francis Regional Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Minnesota Oncology Hematology PA-Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Fairview Lakes Medical Center Recruiting
Wyoming, Minnesota, United States, 55092
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
United States, Mississippi
Baptist Memorial Hospital and Cancer Center-Golden Triangle Recruiting
Columbus, Mississippi, United States, 39705
Contact: Site Public Contact    901-226-1366    BCCclintrials@bmhcc.org   
Principal Investigator: Drew S. Dill         
Baptist Memorial Hospital and Cancer Center-Union County Recruiting
New Albany, Mississippi, United States, 38652
Contact: Site Public Contact    901-226-1366    BCCclintrials@bmhcc.org   
Principal Investigator: Drew S. Dill         
Baptist Memorial Hospital and Cancer Center-Oxford Recruiting
Oxford, Mississippi, United States, 38655
Contact: Site Public Contact    901-226-1366    BCCclintrials@bmhcc.org   
Principal Investigator: Drew S. Dill         
Baptist Memorial Hospital and Cancer Center-Desoto Recruiting
Southhaven, Mississippi, United States, 38671
Contact: Site Public Contact    901-226-1366    BCCclintrials@bmhcc.org   
Principal Investigator: Drew S. Dill         
United States, Missouri
Capital Region Southwest Campus Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Site Public Contact    573-632-4814    swooden@mail.crmc.org   
Principal Investigator: Bryan A. Faller         
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Site Public Contact    417-269-4520      
Principal Investigator: Jay W. Carlson         
United States, Nebraska
CHI Health Good Samaritan Recruiting
Kearney, Nebraska, United States, 68847
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
United States, North Carolina
Mission Hospital Inc-Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Site Public Contact    828-213-4150    leslie.verner@msj.org   
Principal Investigator: Christopher H. Chay         
AdventHealth Infusion Center Asheville Recruiting
Asheville, North Carolina, United States, 28803
Contact: Site Public Contact    828-650-8037    Heather.M.Duncan@AdventHealth.com   
Principal Investigator: Raymond Thertulien         
Gaston Hematology and Oncology Associates-Belmont Suspended
Belmont, North Carolina, United States, 28012
Southeastern Medical Oncology Center-Clinton Recruiting
Clinton, North Carolina, United States, 28328
Contact: Site Public Contact    919-587-9077    ecooke@cancersmoc.com   
Principal Investigator: Nagesh H. Jayaram         
CaroMont Regional Medical Center Recruiting
Gastonia, North Carolina, United States, 28054
Contact: Site Public Contact    704-834-2810    tammy.cozad@caromonthealth.org   
Principal Investigator: Eun-mi Yu         
Gaston Hematology and Oncology Associates Suspended
Gastonia, North Carolina, United States, 28054
Southeastern Medical Oncology Center-Goldsboro Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: Site Public Contact    919-587-9077    ecooke@cancersmoc.com   
Principal Investigator: Nagesh H. Jayaram         
Cone Health Cancer Center Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Site Public Contact    336-832-0821    vivian.sheidler@conehealth.com   
Principal Investigator: Vinay K. Gudena         
Margaret R Pardee Memorial Hospital Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: Site Public Contact    828-696-4716    karen.morris@unchealth.unc.edu   
Principal Investigator: James E. Radford         
AdventHealth Hendersonville Recruiting
Hendersonville, North Carolina, United States, 28792
Contact: Site Public Contact    828-650-8037    Heather.M.Duncan@AdventHealth.com   
Principal Investigator: Raymond Thertulien         
Southeastern Medical Oncology Center-Jacksonville Recruiting
Jacksonville, North Carolina, United States, 28546
Contact: Site Public Contact    910-353-0824    ecooke@cancersmoc.com   
Principal Investigator: Nagesh H. Jayaram         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Site Public Contact    336-713-6771      
Principal Investigator: Heidi D. Klepin         
United States, North Dakota
Sanford Bismarck Medical Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Site Public Contact    701-323-5760    OncologyClinicalTrialsFargo@sanfordhealth.org   
Principal Investigator: Preston D. Steen         
Sanford Broadway Medical Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Site Public Contact    701-323-5760    OncologyClinicalTrialsFargo@sanfordhealth.org   
Principal Investigator: Preston D. Steen         
Sanford Roger Maris Cancer Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Site Public Contact    701-234-6161    OncologyClinicalTrialsFargo@sanfordhealth.org   
Principal Investigator: Preston D. Steen         
United States, Ohio
Good Samaritan Hospital - Cincinnati Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Bethesda North Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
TriHealth Cancer Institute-Westside Recruiting
Cincinnati, Ohio, United States, 45247
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
TriHealth Cancer Institute-Anderson Recruiting
Cincinnati, Ohio, United States, 45255
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Site Public Contact    614-566-4475    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
Armes Family Cancer Center Recruiting
Findlay, Ohio, United States, 45840
Contact: Site Public Contact    937-775-1350    som_dcop@wright.edu   
Principal Investigator: Howard M. Gross         
Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: Site Public Contact    740-348-4000    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
United States, Oregon
Kaiser Permanente Northwest Recruiting
Portland, Oregon, United States, 97227
Contact: Site Public Contact    503-335-2400    information@kpchr.org   
Principal Investigator: Sandeep H. Mashru         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Site Public Contact    570-271-5251    HemonCCTrials@geisinger.edu   
Principal Investigator: Victor G. Vogel         
Geisinger Medical Center-Cancer Center Hazleton Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Site Public Contact    570-459-2901    HemonCCTrials@geisinger.edu   
Principal Investigator: Victor G. Vogel         
Geisinger Cancer Services-Pottsville Recruiting
Pottsville, Pennsylvania, United States, 17901
Contact: Site Public Contact    800-275-6401    HemonCCTrials@geisinger.edu   
Principal Investigator: Victor G. Vogel         
Community Medical Center Recruiting
Scranton, Pennsylvania, United States, 18510
Contact: Site Public Contact    570-703-4768    HemonCCTrials@geisinger.edu   
Principal Investigator: Victor G. Vogel         
Geisinger Wyoming Valley/Henry Cancer Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Site Public Contact    570-271-5251    HemonCCTrials@geisinger.edu   
Principal Investigator: Victor G. Vogel         
United States, South Carolina
AnMed Health Cancer Center Recruiting
Anderson, South Carolina, United States, 29621
Contact: Site Public Contact    864-512-4651    rhonda.ballew@anmedhealth.org   
Principal Investigator: John E. Doster         
Greenville Health System Cancer Institute-Easley Recruiting
Easley, South Carolina, United States, 29640
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Gibbs Cancer Center-Gaffney Recruiting
Gaffney, South Carolina, United States, 29341
Contact: Site Public Contact    864-560-6104    kmertz-rivera@gibbscc.org   
Principal Investigator: Amarinthia (Amy) Curtis         
Tidelands Georgetown Memorial Hospital Recruiting
Georgetown, South Carolina, United States, 29440
Contact: Site Public Contact    843-545-5600    broe@tidelandshealth.org   
Principal Investigator: Frank J. Brescia         
Greenville Health System Cancer Institute-Butternut Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Self Regional Healthcare Recruiting
Greenwood, South Carolina, United States, 29646
Contact: Site Public Contact    864-725-4771    nmcgaha@selfregional.org   
Principal Investigator: Frank J. Brescia         
Greenville Health System Cancer Institute-Greer Recruiting
Greer, South Carolina, United States, 29650
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Gibbs Cancer Center-Pelham Recruiting
Greer, South Carolina, United States, 29651
Contact: Site Public Contact    864-560-6104    kmertz-rivera@gibbscc.org   
Principal Investigator: Amarinthia (Amy) Curtis         
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Spartanburg Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Site Public Contact    864-560-6104    kmertz-rivera@gibbscc.org   
Principal Investigator: Amarinthia (Amy) Curtis         
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
MGC Hematology Oncology-Union Recruiting
Union, South Carolina, United States, 29379
Contact: Site Public Contact    864-560-6104    kmertz-rivera@gibbscc.org   
Principal Investigator: Amarinthia (Amy) Curtis         
United States, South Dakota
Sanford Cancer Center Oncology Clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Site Public Contact    605-312-3320    OncologyClinicTrialsSF@sanfordhealth.org   
Principal Investigator: Preston D. Steen         
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Site Public Contact    605-312-3320    OncologyClinicalTrialsSF@SanfordHealth.org   
Principal Investigator: Preston D. Steen         
United States, Tennessee
Baptist Memorial Hospital and Cancer Center-Memphis Recruiting
Memphis, Tennessee, United States, 38120
Contact: Site Public Contact    901-226-1366    BCCclintrials@bmhcc.org   
Principal Investigator: Drew S. Dill         
Baptist Memorial Hospital for Women Recruiting
Memphis, Tennessee, United States, 38120
Contact: Site Public Contact    901-226-1366    BCCclintrials@bmhcc.org   
Principal Investigator: Drew S. Dill         
Family Cancer Center-Memphis Suspended
Memphis, Tennessee, United States, 38120
United States, Wisconsin
Aurora Cancer Care-Southern Lakes VLCC Recruiting
Burlington, Wisconsin, United States, 53105
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Marshfield Clinic-Chippewa Center Recruiting
Chippewa Falls, Wisconsin, United States, 54729
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Arlene A. Gayle         
Marshfield Medical Center-EC Cancer Center Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Arlene A. Gayle         
Aurora Health Center-Fond du Lac Recruiting
Fond Du Lac, Wisconsin, United States, 54937
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Aurora Health Care Germantown Health Center Recruiting
Germantown, Wisconsin, United States, 53022
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Aurora Cancer Care-Grafton Recruiting
Grafton, Wisconsin, United States, 53024
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Saint Vincent Hospital Cancer Center Green Bay Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Site Public Contact    920-433-8889    Christy.Gilchrist@hshs.org   
Principal Investigator: Anthony J. Jaslowski         
Saint Vincent Hospital Cancer Center at Saint Mary's Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Anthony J. Jaslowski         
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Aurora Cancer Care-Kenosha South Recruiting
Kenosha, Wisconsin, United States, 53142
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Gundersen Lutheran Medical Center Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Site Public Contact    608-775-2385    cancerctr@gundersenhealth.org   
Principal Investigator: Collin D. Driscoll         
Marshfield Clinic - Ladysmith Center Recruiting
Ladysmith, Wisconsin, United States, 54848
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Arlene A. Gayle         
Holy Family Memorial Hospital Recruiting
Manitowoc, Wisconsin, United States, 54221
Contact: Site Public Contact    920-320-2749      
Principal Investigator: Anthony J. Jaslowski         
Aurora Bay Area Medical Group-Marinette Suspended
Marinette, Wisconsin, United States, 54143
Saint Vincent Hospital Cancer Center at Marinette Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Site Public Contact    920-433-8889    Christy.Gilchrist@hshs.org   
Principal Investigator: Anthony J. Jaslowski         
Marshfield Medical Center-Marshfield Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Arlene A. Gayle         
Aurora Cancer Care-Milwaukee Recruiting
Milwaukee, Wisconsin, United States, 53209
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Thomas J. Saphner         
Aurora Sinai Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Marshfield Clinic-Minocqua Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Arlene A. Gayle         
Cancer Center of Western Wisconsin Recruiting
New Richmond, Wisconsin, United States, 54017
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: Pamala A. Pawloski         
Saint Vincent Hospital Cancer Center at Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Site Public Contact    920-433-8889    Christy.Gilchrist@hshs.org   
Principal Investigator: Anthony J. Jaslowski         
Vince Lombardi Cancer Clinic - Oshkosh Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Aurora Cancer Care-Racine Recruiting
Racine, Wisconsin, United States, 53406
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Marshfield Medical Center-Rice Lake Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Arlene A. Gayle         
Vince Lombardi Cancer Clinic-Sheboygan Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Marshfield Clinic Stevens Point Center Recruiting
Stevens Point, Wisconsin, United States, 54482
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Arlene A. Gayle         
Saint Vincent Hospital Cancer Center at Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235-1495
Contact: Site Public Contact    920-433-8889    Christy.Gilchrist@hshs.org   
Principal Investigator: Anthony J. Jaslowski         
Aurora Medical Center in Summit Recruiting
Summit, Wisconsin, United States, 53066
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Vince Lombardi Cancer Clinic-Two Rivers Recruiting
Two Rivers, Wisconsin, United States, 54241
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Marshfield Clinic-Wausau Center Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Arlene A. Gayle         
Aurora Cancer Care-Milwaukee West Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Aurora West Allis Medical Center Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Thomas J. Saphner         
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Arlene A. Gayle         
Marshfield Clinic - Wisconsin Rapids Center Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Arlene A. Gayle         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Stephen R Rapp, PhD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02822573     History of Changes
Other Study ID Numbers: IRB00041707
3UG1CA189824-04S1 ( U.S. NIH Grant/Contract )
WF-97116 ( Other Identifier: NCI )
NCI-2016-01050 ( Registry Identifier: NCI CTRP Trial ID )
IRB00041707 ( Other Identifier: Wake Forest IRB ID )
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide.
Time Frame: See NIH Policy
Access Criteria: request using URL below
URL: https://nctn-data-archive.nci.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Donepezil
Cognition
Breast Cancer
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents