Naloxegol in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/4/2019 |
Start Date: | October 13, 2017 |
End Date: | August 2027 |
Contact: | Pankaj Gupta, MD |
Email: | pankaj.gupta@va.gov |
Phone: | 612-467-4135 |
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer
This randomized pilot clinical trial studies the side effects and best dose of naloxegol and
to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer.
Naloxegol may relieve some of the side effects of opioid pain medication and fight off future
growth in the cancer.
to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer.
Naloxegol may relieve some of the side effects of opioid pain medication and fight off future
growth in the cancer.
PRIMARY OBJECTIVES:
I. To determine feasibility and safety of long-term administration of two doses of a
peripheral opioid receptor antagonist in patients with advanced non-small cell lung cancer
(NSCLC) receiving first-line systemic therapy.
SECONDARY OBJECTIVES:
I. To explore whether patients randomized to one or both of the two study drug arms have less
decline in health-related quality of life (HRQoL) than patients randomized to placebo.
II. To estimate the difference in the pain levels and opioid/non-opioid analgesic
requirements between patients receiving naloxegol or placebo.
III. To estimate the difference in the adverse peripheral effects of opioids (e.g.
constipation, nausea/emesis, dry mouth and urinary retention) between patients receiving
naloxegol or placebo.
IV. To explore whether there is a signal that naloxegol may be associated with longer
progression-free survival (PFS) and overall survival (OS).
V. To evaluate the difference in discontinuation rate of systemic therapy due to adverse
events (AEs) and deaths attributable to systemic therapy.
After completion of study treatment, patients are followed up every 3 months.
I. To determine feasibility and safety of long-term administration of two doses of a
peripheral opioid receptor antagonist in patients with advanced non-small cell lung cancer
(NSCLC) receiving first-line systemic therapy.
SECONDARY OBJECTIVES:
I. To explore whether patients randomized to one or both of the two study drug arms have less
decline in health-related quality of life (HRQoL) than patients randomized to placebo.
II. To estimate the difference in the pain levels and opioid/non-opioid analgesic
requirements between patients receiving naloxegol or placebo.
III. To estimate the difference in the adverse peripheral effects of opioids (e.g.
constipation, nausea/emesis, dry mouth and urinary retention) between patients receiving
naloxegol or placebo.
IV. To explore whether there is a signal that naloxegol may be associated with longer
progression-free survival (PFS) and overall survival (OS).
V. To evaluate the difference in discontinuation rate of systemic therapy due to adverse
events (AEs) and deaths attributable to systemic therapy.
After completion of study treatment, patients are followed up every 3 months.
Inclusion Criteria:
- Advanced (stage IIIB or IV) non-small cell lung cancer diagnosed by biopsy of the
primary or metastatic site (American Joint Committee on Cancer 7.0)
- No known presence of known EGFR or EML4-ALK driver mutations in the tumor
- Initiation of first-line chemotherapy with a platinum-pemetrexed-based regimen within
14 days of registration or planning to initiate within 14 days after registration; no
planned initiation of definitive (potentially curative) concurrent chemo-radiation
- No prior systemic therapy for advanced NSCLC, including chemotherapy, targeted therapy
or immunotherapy; prior palliative radiation permitted; prior adjuvant
chemotherapy/radiation is permitted
- No past or current use of mixed opioid agonist/opioid antagonists or other opioid
antagonists
- No methadone within 4 weeks prior to registration
- Patients must have used opioid medication(s) for pain at some time in the 4 weeks
prior to registration; current use of opioids (at the time of registration) and/or
later during the course of the study is permitted but not required
- Expected survival > 3 months
- No concurrently active second invasive malignancies except non-melanoma skin cancer
- No history of gastrointestinal obstruction, or conditions that increase the risk of
gastrointestinal obstruction, perforation, bleeding or impairment of the
gastrointestinal wall; no abdominal surgery within 60 days of registration
- No acute gastrointestinal conditions, such as: obstruction, fecal impaction,
obstipation, acute surgical abdomen, ongoing need for manual maneuvers to induce bowel
movements (such as digital evacuation)
- No conditions that may compromise blood-brain barrier permeability (e.g., multiple
sclerosis, recent brain trauma, Alzheimer's disease, or uncontrolled seizures)
- No symptomatic and untreated brain metastases; patients will be eligible for
study if radiation therapy for brain metastases was completed at least 7 days
prior to registration
- Patients having received stereotactic radiation will be eligible if the radiation
was completed at least 7 days prior to registration
- Patients having undergone surgical resection of brain metastases will be eligible
after they have healed and recovered from the surgical intervention sufficiently
to start systemic treatment for NSCLC, as determined by a neurosurgeon
- No known leptomeningeal carcinomatosis
- No history of myocardial infarction =< 6 months prior to registration; no current
symptomatic congestive heart failure, uncontrolled angina, or uncontrolled cardiac
arrhythmias
- No severe hepatic impairment (Child-Pugh class C) or acute liver disease
- No known serious or severe hypersensitivity reaction to naloxegol or any of its
excipients
- No concurrent use of moderate/strong CYP3A4 inhibitors, or strong CYP3A4 inducers
- Not pregnant and not nursing; for women of childbearing potential only, a negative
pregnancy test done =< 7 days prior to registration is required; a female of
childbearing potential is a sexually mature female who: 1) has not undergone a
hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal
for at least 12 consecutive months (i.e., has had menses at any time in the preceding
12 consecutive months)
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Calculated (calc.) creatinine clearance >= 60 mL/min calculated using the
Cockcroft-Gault formula
- Total bilirubin =< 1.2 x upper limit of normal (ULN) unless due to Gilbert's disease
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper
limit of normal (ULN)
We found this trial at
584
sites
Plant City, Florida 33563
Principal Investigator: Akm Mosharraf Hossain
Phone: 813-707-2155
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
(484) 884-2200
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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Bremerton, Washington 98310
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Hongbin Chen
Phone: 800-767-9355
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 Hurley Plaza
Flint, Michigan 48503
Flint, Michigan 48503
(810) 262-9000
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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2500 N State St
Jackson, Mississippi 39216
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: John C. Ruckdeschel
Phone: 601-815-6700
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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524 South Park Street
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
(269) 341-7654
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
(269) 382-2500
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
(702) 383-2000
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
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Phone: 503-215-2614
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Seattle, Washington 98104
Principal Investigator: Alison K. Conlin
Phone: 206-215-3086
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'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-487-7447
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-486-6000
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2226 Liliha Street
'Aiea, Hawaii 96701
'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-678-9000
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'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-539-2273
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Aberdeen, Washington 98520
Principal Investigator: Alison K. Conlin
Phone: 360-412-8958
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Allentown, Pennsylvania 18103
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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Ames, Iowa 50010
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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Ames, Iowa 50010
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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Anaconda, Montana 59711
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Anchorage, Alaska 98508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 773-702-9171
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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Anchorage, Alaska 99504
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
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5301 McAuley Drive
Ann Arbor, Michigan 48197
Ann Arbor, Michigan 48197
734-712-3456
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Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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921 North Oak Park Boulevard
Arroyo Grande, California 93420
Arroyo Grande, California 93420
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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1625 Maple Lane
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Ashland, Wisconsin 54806
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Auburn, New York 13021
Principal Investigator: Jeffrey J. Kirshner
Phone: 315-472-7504
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12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
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Phone: 720-848-0650
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Phone: 303-777-2663
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1501 S Potomac St
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Aurora, Colorado 80012
(303) 695-2600
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2000 Ogden Ave
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Aurora, Illinois 60504
(630) 978-6200
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Phone: 630-978-6212
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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3325 Pocahontas Road
Baker City, Oregon 97814
Baker City, Oregon 97814
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Phone: 734-712-3671
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4305 New Shepherdsville Road
Bardstown, Kentucky 40004
Bardstown, Kentucky 40004
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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265 Fremont St
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
(269) 245-8166
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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440 East Main Street
Bay Shore, New York 11706
Bay Shore, New York 11706
Principal Investigator: Nagashree Seetharamu
Phone: 516-734-8896
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3535 Pentagon Boulevard
Beavercreek, Ohio 45431
Beavercreek, Ohio 45431
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Bellingham, Washington 98225
Principal Investigator: Alison K. Conlin
Phone: 360-715-4133
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800 Farson Street
Belpre, Ohio 45714
Belpre, Ohio 45714
(740) 401-0417
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Phone: 800-523-3977
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Bemidji, Minnesota 56601
Principal Investigator: Preston D. Steen
Phone: 218-333-5000
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Bend, Oregon 97701
Principal Investigator: Alison K. Conlin
Phone: 541-706-2909
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Beverly, Massachusetts 01915
Principal Investigator: Shakeeb A. Yunus
Phone: 978-922-3000
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Billings, Montana 59102
Principal Investigator: Keren Sturtz
Phone: 800-648-6274
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1233 North 30th Street
Billings, Montana 59101
Billings, Montana 59101
406-237-7000
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Phone: 406-969-6060
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300 N. Seventh St.
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
(701) 323-6000
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Phone: 701-323-5760
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1505 Eastland Drive
Bloomington, Illinois 61701
Bloomington, Illinois 61701
309-662-2102
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Phone: 330-629-7500
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Boise, Idaho 83706
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Phone: 734-712-3671
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100 E Idaho St
Boise, Idaho 83712
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(208) 381-2711
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Bonne Terre, Missouri 63628
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Phone: 314-996-5569
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Boone, Iowa 50036
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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1100 Balsam Ave
Boulder, Colorado 80304
Boulder, Colorado 80304
(303) 440-2273
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Phone: 303-777-2663
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Boulder, Colorado 80303
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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915 Highland Blvd
Bozeman, Montana 59715
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Brainerd, Minnesota 56401
Principal Investigator: Bret E. Friday
Phone: 773-702-9171
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Bremerton, Washington 98310
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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7575 Grand River Avenue
Brighton, Michigan 48114
Brighton, Michigan 48114
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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7575 Grand River Avenue
Brighton, Michigan 48114
Brighton, Michigan 48114
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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Bryan, Texas 77802
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Buffalo, New York 14215
Principal Investigator: Lynn M. Steinbrenner
Phone: 716-862-3191
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Burbank, California
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Phone: 818-847-4793
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Burien, Washington 98166
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Burlington, Wisconsin 53105
Principal Investigator: Shamsuddin Virani
Phone: 414-302-2304
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
(952) 892-2000
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Phone: 952-993-1517
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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400 South Clark Street
Butte, Montana 59701
Butte, Montana 59701
406-723-2500
Principal Investigator: Keren Sturtz
Phone: 406-723-2621
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3123 Medical Dr
Caldwell, Idaho 83605
Caldwell, Idaho 83605
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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210 W Walnut St
Canton, Illinois 61520
Canton, Illinois 61520
309-647-5240
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
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1600 South Canton Center Road
Canton, Michigan 48188
Canton, Michigan 48188
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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1600 South Canton Center Road
Canton, Michigan 48188
Canton, Michigan 48188
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
573-331-3000
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Phone: 573-334-2230
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
(573) 519-4725
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Phone: 573-651-5550
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Carbondale, Illinois 62902
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Phone: 618-457-5200
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401 North Hooper Street
Caro, Michigan 48723
Caro, Michigan 48723
Principal Investigator: Tareq Al Baghdadi
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Carson City, Nevada 89703
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Phone: 702-384-0013
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Carterville, Illinois 62918
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Phone: 618-985-3333
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160 S Adams St
Carthage, Illinois 62321
Carthage, Illinois 62321
(217) 357-6877
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Phone: 309-243-3605
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Phone: 937-775-1350
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Centerville, Ohio 45459
Principal Investigator: Howard M. Gross
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Centralia, Illinois 62801
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Phone: 217-876-4740
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Chadds Ford, Pennsylvania 19317
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Phone: 302-623-4450
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505 S Plummer Ave
Chanute, Kansas 66720
Chanute, Kansas 66720
(620) 431-7580
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Phone: 316-268-5374
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Phone: 308-398-6518
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14650 East Old US Highway 12
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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775 South Main Street
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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Cheyenne, Wyoming 82001
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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1200 West Harrison Stree
Chicago, Illinois 60607
Chicago, Illinois 60607
(312) 996-4350
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Phone: 312-355-3046
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272 Hospital Rd
Chillicothe, Ohio 45601
Chillicothe, Ohio 45601
740-779-7500
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Phone: 877-779-7585
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Cincinnati, Ohio 45220
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Phone: 308-398-6518
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Cincinnati, Ohio 45236
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, Ohio 45242
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Cincinnati, Ohio 45247
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Cincinnati, Ohio 45255
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Clackamas, Oregon 97015
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
Clackamas, Oregon 97015
(503) 513-3300
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Phone: 503-215-2614
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