- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00550836
Erlotinib and Gemcitabine With or Without Panitumumab in Treating Patients With Metastatic Pancreatic Cancer
Randomized Phase II Trial of Panitumumab, Erlotinib and Gemcitabine vs. Erlotinib and Gemcitabine in Patients With Untreated, Metastatic Pancreatic Adenocarcinoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying how well giving panitumumab together with gemcitabine and erlotinib works compared to giving gemcitabine and erlotinib alone in treating patients with metastatic pancreatic cancer.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
OBJECTIVES:
Primary
- To assess whether the addition of panitumumab (a dual-epidermal growth factor receptor inhibitor) to standard chemotherapy comprising gemcitabine hydrochloride and erlotinib hydrochloride results in an improvement in overall survival of patients with previously untreated, metastatic adenocarcinoma of the pancreas.
Secondary
- To compare objective response rates, progression-free survival, time to treatment failure, quality of life, and adverse event rates in patients treated with these regimens.
- To evaluate the downstream marker, KRAS, in stool specimens.
OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and prior adjuvant chemotherapy (yes vs no). The first 6 patients are assigned to arm II. Subsequent patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above in the absence of disease progression or unacceptable toxicity. Patients achieving a CR after 4 courses of treatment receive maintenance therapy comprising erlotinib hydrochloride daily until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression (using the first progression tumor measurements as the new baseline reference).
- Arm II: Patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in arm I and panitumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above in the absence of disease progression or unacceptable toxicity. Patients achieving a CR after 4 courses of treatment receive maintenance therapy comprising erlotinib hydrochloride daily and panitumumab every 2 weeks until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression (using the first progression tumor measurements as the new baseline reference).
Stool samples are collected at baseline and analyzed for KRAS mutations via protein analyses.
Quality of life will be assessed at baseline, every 2 courses during treatment, and at the end of treatment.
After the second progression, patients are followed every 3-6 months for 2 years.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Stany Zjednoczone, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Stany Zjednoczone, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Stany Zjednoczone, 80210
- Porter Adventist Hospital
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Denver, Colorado, Stany Zjednoczone, 80220
- Rose Medical Center
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Denver, Colorado, Stany Zjednoczone, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Stany Zjednoczone, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Stany Zjednoczone, 80218
- St. Joseph Hospital
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Denver, Colorado, Stany Zjednoczone, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Stany Zjednoczone, 80110
- Swedish Medical Center
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Fort Collins, Colorado, Stany Zjednoczone, 80528
- Front Range Cancer Specialists
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Grand Junction, Colorado, Stany Zjednoczone, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Stany Zjednoczone, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Stany Zjednoczone, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Stany Zjednoczone, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Stany Zjednoczone, 80539
- McKee Medical Center
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Thornton, Colorado, Stany Zjednoczone, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Stany Zjednoczone, 80033
- Exempla Lutheran Medical Center
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Connecticut
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Hartford, Connecticut, Stany Zjednoczone, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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Florida
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Jacksonville, Florida, Stany Zjednoczone, 32224
- Mayo Clinic - Jacksonville
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Hawaii
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Aiea, Hawaii, Stany Zjednoczone, 96701
- Kapiolani Medical Center at Pali Momi
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Stany Zjednoczone, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- OnCare Hawaii, Incorporated - Lusitana
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- Queen's Cancer Institute at Queen's Medical Center
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- Straub Clinic and Hospital, Incorporated
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Honolulu, Hawaii, Stany Zjednoczone, 96817
- Hawaii Medical Center - East
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Honolulu, Hawaii, Stany Zjednoczone, 96817
- OnCare Hawaii, Incorporated - Kuakini
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Wailuku, Hawaii, Stany Zjednoczone, 96793
- Pacific Cancer Institute - Maui
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Illinois
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Bloomington, Illinois, Stany Zjednoczone, 61701
- St. Joseph Medical Center
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Bloomington%, Illinois, Stany Zjednoczone, 61701
- Illinois CancerCare - Bloomington
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Canton, Illinois, Stany Zjednoczone, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Stany Zjednoczone, 61520
- Graham Hospital
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Carthage, Illinois, Stany Zjednoczone, 62321
- Memorial Hospital
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Carthage, Illinois, Stany Zjednoczone, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Stany Zjednoczone, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Stany Zjednoczone, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Stany Zjednoczone, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, Stany Zjednoczone, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Stany Zjednoczone, 62644
- Mason District Hospital
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Havana, Illinois, Stany Zjednoczone, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Stany Zjednoczone, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Stany Zjednoczone, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Stany Zjednoczone, 61455
- Mcdonough District Hospital
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Moline, Illinois, Stany Zjednoczone, 61265
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Moline, Illinois, Stany Zjednoczone, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Stany Zjednoczone, 61462
- Illinois CancerCare - Monmouth
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Normal, Illinois, Stany Zjednoczone, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Stany Zjednoczone, 61761
- Community Cancer Center
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Normal, Illinois, Stany Zjednoczone, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Stany Zjednoczone, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Stany Zjednoczone, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Stany Zjednoczone, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Stany Zjednoczone, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Stany Zjednoczone, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Stany Zjednoczone, 61614
- Proctor Hospital
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Peoria, Illinois, Stany Zjednoczone, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Stany Zjednoczone, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Stany Zjednoczone, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Stany Zjednoczone, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Stany Zjednoczone, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Stany Zjednoczone, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Stany Zjednoczone, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Stany Zjednoczone, 61362
- Illinois CancerCare - Spring Valley
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Indiana
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Beech Grove, Indiana, Stany Zjednoczone, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Elkhart, Indiana, Stany Zjednoczone, 46515
- Elkhart General Hospital
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Elkhart, Indiana, Stany Zjednoczone, 46514-2098
- Elkhart Clinic, LLC
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Kokomo, Indiana, Stany Zjednoczone, 46904
- Howard Community Hospital
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La Porte, Indiana, Stany Zjednoczone, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Richmond, Indiana, Stany Zjednoczone, 47374
- Reid Hospital & Health Care Services
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South Bend, Indiana, Stany Zjednoczone, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Stany Zjednoczone, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Stany Zjednoczone, 46617
- Saint Joseph Regional Medical Center
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South Bend, Indiana, Stany Zjednoczone, 46617
- South Bend Clinic
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South Bend, Indiana, Stany Zjednoczone, 46601
- Michiana Hematology-Oncology, PC - South Bend
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Iowa
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Ames, Iowa, Stany Zjednoczone, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, Stany Zjednoczone, 52722
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Cedar Rapids, Iowa, Stany Zjednoczone, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Stany Zjednoczone, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Clive, Iowa, Stany Zjednoczone, 50325
- Medical Oncology and Hematology Associates - West Des Moines
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Des Moines, Iowa, Stany Zjednoczone, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Stany Zjednoczone, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Stany Zjednoczone, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Stany Zjednoczone, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Stany Zjednoczone, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stany Zjednoczone, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, Stany Zjednoczone, 50307
- Mercy Capitol Hospital
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Sioux City, Iowa, Stany Zjednoczone, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Stany Zjednoczone, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Stany Zjednoczone, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Chanute, Kansas, Stany Zjednoczone, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Stany Zjednoczone, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Stany Zjednoczone, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Stany Zjednoczone, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Stany Zjednoczone, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Stany Zjednoczone, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Stany Zjednoczone, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Stany Zjednoczone, 67905
- Cancer Center of Kansas, PA - Liberal
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Newton, Kansas, Stany Zjednoczone, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Stany Zjednoczone, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Stany Zjednoczone, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Stany Zjednoczone, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Stany Zjednoczone, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Stany Zjednoczone, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Stany Zjednoczone, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Stany Zjednoczone, 67214
- CCOP - Wichita
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Wichita, Kansas, Stany Zjednoczone, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Stany Zjednoczone, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Stany Zjednoczone, 67156
- Cancer Center of Kansas, PA - Winfield
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Louisiana
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Baton Rouge, Louisiana, Stany Zjednoczone, 70809
- Ochsner Health Center - Bluebonnet
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Covington, Louisiana, Stany Zjednoczone, 70433
- Ochsner Health Center - Covington
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New Orleans, Louisiana, Stany Zjednoczone, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Stany Zjednoczone, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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Michigan
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Adrian, Michigan, Stany Zjednoczone, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Stany Zjednoczone, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Stany Zjednoczone, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, Stany Zjednoczone, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Stany Zjednoczone, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Stany Zjednoczone, 48503
- Hurley Medical Center
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Flint, Michigan, Stany Zjednoczone, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, Stany Zjednoczone, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Stany Zjednoczone, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Stany Zjednoczone, 49201
- Foote Memorial Hospital
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Lambertville, Michigan, Stany Zjednoczone, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Lansing, Michigan, Stany Zjednoczone, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Stany Zjednoczone, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, Stany Zjednoczone, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Stany Zjednoczone, 48162
- Mercy Memorial Hospital - Monroe
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Pontiac, Michigan, Stany Zjednoczone, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Stany Zjednoczone, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Stany Zjednoczone, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Saint Joseph, Michigan, Stany Zjednoczone, 49085
- Lakeside Cancer Specialists, PLLC
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St. Joseph, Michigan, Stany Zjednoczone, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Warren, Michigan, Stany Zjednoczone, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, Stany Zjednoczone, 56308
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Bemidji, Minnesota, Stany Zjednoczone, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Stany Zjednoczone, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Stany Zjednoczone, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Edina, Minnesota, Stany Zjednoczone, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Stany Zjednoczone, 56537
- Fergus Falls Medical Group, PA
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Fridley, Minnesota, Stany Zjednoczone, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Stany Zjednoczone, 55350
- Hutchinson Area Health Care
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Maplewood, Minnesota, Stany Zjednoczone, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Stany Zjednoczone, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Stany Zjednoczone, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Stany Zjednoczone, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, Stany Zjednoczone, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Stany Zjednoczone, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Stany Zjednoczone, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Stany Zjednoczone, 55102
- United Hospital
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Shakopee, Minnesota, Stany Zjednoczone, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St. Paul, Minnesota, Stany Zjednoczone, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, Stany Zjednoczone, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Stany Zjednoczone, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Montana
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Billings, Montana, Stany Zjednoczone, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Stany Zjednoczone, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Stany Zjednoczone, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Stany Zjednoczone, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Stany Zjednoczone, 59107-7000
- Billings Clinic - Downtown
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Bozeman, Montana, Stany Zjednoczone, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Stany Zjednoczone, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Stany Zjednoczone, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Stany Zjednoczone, 59405
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Great Falls, Montana, Stany Zjednoczone, 59405-5309
- Big Sky Oncology
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Great Falls, Montana, Stany Zjednoczone, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Havre, Montana, Stany Zjednoczone, 59501
- Northern Montana Hospital
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Helena, Montana, Stany Zjednoczone, 59601
- St. Peter's Hospital
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Kalispell, Montana, Stany Zjednoczone, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Stany Zjednoczone, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Stany Zjednoczone, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Stany Zjednoczone, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Stany Zjednoczone, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Lincoln, Nebraska, Stany Zjednoczone, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Stany Zjednoczone, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Stany Zjednoczone, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Stany Zjednoczone, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Stany Zjednoczone, 68131-2197
- Creighton University Medical Center
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North Carolina
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Rutherfordton, North Carolina, Stany Zjednoczone, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, Stany Zjednoczone, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Stany Zjednoczone, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Stany Zjednoczone, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Stany Zjednoczone, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Stany Zjednoczone, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Stany Zjednoczone, 58122
- MeritCare Broadway
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Grand Forks, North Dakota, Stany Zjednoczone, 58201
- Altru Cancer Center at Altru Hospital
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Ohio
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Bowling Green, Ohio, Stany Zjednoczone, 43402
- Wood County Oncology Center
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Clyde, Ohio, Stany Zjednoczone, 43410
- North Coast Cancer Care - Clyde
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Dayton, Ohio, Stany Zjednoczone, 45405
- Grandview Hospital
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Dayton, Ohio, Stany Zjednoczone, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Stany Zjednoczone, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Stany Zjednoczone, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, Stany Zjednoczone, 45420
- CCOP - Dayton
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Elyria, Ohio, Stany Zjednoczone, 44035
- Community Cancer Center
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Elyria, Ohio, Stany Zjednoczone, 44035
- Hematology Oncology Center
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Findlay, Ohio, Stany Zjednoczone, 45840
- Blanchard Valley Medical Associates
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Franklin, Ohio, Stany Zjednoczone, 45005-1066
- Middletown Regional Hospital
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Greenville, Ohio, Stany Zjednoczone, 45331
- Wayne Hospital
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Kettering, Ohio, Stany Zjednoczone, 45429
- Charles F. Kettering Memorial Hospital
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Lima, Ohio, Stany Zjednoczone, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Stany Zjednoczone, 43537
- St. Luke's Hospital
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Maumee, Ohio, Stany Zjednoczone, 43537-1839
- Northwest Ohio Oncology Center
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Norwalk, Ohio, Stany Zjednoczone, 44857
- Fisher-Titus Medical Center
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Oregon, Ohio, Stany Zjednoczone, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Stany Zjednoczone, 43616
- Toledo Clinic - Oregon
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Sandusky, Ohio, Stany Zjednoczone, 44870
- North Coast Cancer Care, Incorporated
-
Sylvania, Ohio, Stany Zjednoczone, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, Stany Zjednoczone, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Stany Zjednoczone, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Stany Zjednoczone, 43606
- Toledo Hospital
-
Toledo, Ohio, Stany Zjednoczone, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Stany Zjednoczone, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Stany Zjednoczone, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, Stany Zjednoczone, 43623
- St. Anne Mercy Hospital
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Troy, Ohio, Stany Zjednoczone, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wauseon, Ohio, Stany Zjednoczone, 43567
- Fulton County Health Center
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Wilmington, Ohio, Stany Zjednoczone, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, Stany Zjednoczone, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Oklahoma
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Tulsa, Oklahoma, Stany Zjednoczone, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Oregon
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Milwaukie, Oregon, Stany Zjednoczone, 97222
- Providence Milwaukie Hospital
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Portland, Oregon, Stany Zjednoczone, 97216
- Adventist Medical Center
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Portland, Oregon, Stany Zjednoczone, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
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Portland, Oregon, Stany Zjednoczone, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Stany Zjednoczone, 97225
- Providence St. Vincent Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Stany Zjednoczone, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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Danville, Pennsylvania, Stany Zjednoczone, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hazleton, Pennsylvania, Stany Zjednoczone, 18201
- Geisinger Hazleton Cancer Center
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Sayre, Pennsylvania, Stany Zjednoczone, 18840
- Guthrie Cancer Center at Guthrie Clinic Sayre
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State College, Pennsylvania, Stany Zjednoczone, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, Stany Zjednoczone, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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South Carolina
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Anderson, South Carolina, Stany Zjednoczone, 29621
- AnMed Cancer Center
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Spartanburg, South Carolina, Stany Zjednoczone, 29303
- CCOP - Upstate Carolina
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Spartanburg, South Carolina, Stany Zjednoczone, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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South Dakota
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Rapid City, South Dakota, Stany Zjednoczone, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Stany Zjednoczone, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Stany Zjednoczone, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Virginia
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Fredericksburg, Virginia, Stany Zjednoczone, 22401
- Fredericksburg Oncology, Incorporated
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Washington
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Vancouver, Washington, Stany Zjednoczone, 98668
- Southwest Washington Medical Center Cancer Center
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Wisconsin
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Chippewa Falls, Wisconsin, Stany Zjednoczone, 54729
- Marshfield Clinic - Chippewa Center
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Eau Claire, Wisconsin, Stany Zjednoczone, 54701
- Marshfield Clinic Cancer Care at Regional Cancer Center
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Eau Claire, Wisconsin, Stany Zjednoczone, 54703-1510
- Midelfort Clinic - Luther
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Eau Claire, Wisconsin, Stany Zjednoczone, 54702
- Luther Midlelfort Hospital
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Green Bay, Wisconsin, Stany Zjednoczone, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Stany Zjednoczone, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Stany Zjednoczone, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Stany Zjednoczone, 54303
- St. Mary's Hospital Medical Center - Green Bay
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Manitowoc, Wisconsin, Stany Zjednoczone, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
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Marinette, Wisconsin, Stany Zjednoczone, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Marshfield, Wisconsin, Stany Zjednoczone, 54449
- Marshfield Clinic - Marshfield Center
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Minocqua, Wisconsin, Stany Zjednoczone, 54548
- Marshfield Clinic - Lakeland Center
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Oconto Falls, Wisconsin, Stany Zjednoczone, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Rhinelander, Wisconsin, Stany Zjednoczone, 54501
- Ministry Medical Group at Saint Mary's Hospital
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Rice Lake, Wisconsin, Stany Zjednoczone, 54868
- Marshfield Clinic - Indianhead Center
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Stevens Point, Wisconsin, Stany Zjednoczone, 54481
- Marshfield Clinic at Saint Michael's Hospital
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Sturgeon Bay, Wisconsin, Stany Zjednoczone, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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Wausau, Wisconsin, Stany Zjednoczone, 54401
- Marshfield Clinic - Wausau Center
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Weston, Wisconsin, Stany Zjednoczone, 54476
- Marshfield Clinic - Weston Center
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Wisconsin Rapids, Wisconsin, Stany Zjednoczone, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Wyoming
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Casper, Wyoming, Stany Zjednoczone, 82609
- Rocky Mountain Oncology
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Sheridan, Wyoming, Stany Zjednoczone, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas (ductal or undifferentiated)
- Metastatic disease
- No islet cell, acinar cell, or cystadenocarcinomas
- No locally advanced disease
- No history or known presence of CNS metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 2 times upper limit of normal (ULN) (patients may be stented)
- AST ≤ 2.5 times ULN
- Creatinine ≤ 2.0 times ULN
- Magnesium ≥ lower limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to provide a stool specimen
- No malignancy diagnosed within the past 3 years except basal cell or squamous cell skin cancer, prostate cancer (Gleason < 7), or carcinoma in situ of the cervix
- No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- No clinically significant cardiovascular disease (i.e., myocardial infarction, unstable angina, symptomatic congestive heart failure, or serious uncontrolled cardiac arrhythmia) within the past year
- No known positive test(s) for HIV infection, hepatitis C virus, or acute or chronic active hepatitis B infection
- No liver dysfunction from cirrhosis or viral hepatitis
- No enteral hyperalimentation
- No grapefruit or grapefruit juice during the study
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- More than 4 months since prior radiotherapy, immunotherapy, or biologic therapy
- More than 4 weeks since prior and no elective or planned major surgery
- More than 2 weeks since prior minor and no elective or planned surgery
No prior cytotoxic chemotherapy for metastatic disease
Adjuvant chemotherapy for completely resected disease or chemoradiotherapy for locally advanced disease is allowed, provided it was administered > 6 months prior to study entry
- Adjuvant chemotherapy must not have contained an EGFR inhibitor
- Gemcitabine hydrochloride used as either a radiosensitizer or as maintenance therapy is allowed, provided more than 6 months have elapsed since the last day of treatment
- No prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule EGFR inhibitors (e.g., gefitinib hydrochloride, erlotinib hydrochloride, or lapatinib)
- No concurrent immunotherapy or radiotherapy
- No other concurrent chemotherapy
- No concurrent colony-stimulating factors during the first course of study therapy
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Aktywny komparator: Arm A: GE
Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28.
Treatment repeats every 28 days for 2 courses.
Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above.
Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression.
After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
|
Biorąc pod uwagę IV
Podany doustnie
|
Eksperymentalny: Arm B: PGE
Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15.
Treatment repeats every 28 days for 2 courses.
Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above.
Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression.
After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
|
Biorąc pod uwagę IV
Podany doustnie
Biorąc pod uwagę IV
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Overall Survival
Ramy czasowe: Up to 2 years
|
Overall Survival is defined as the time from registration to death due to any cause.
The estimate will be done using the Kaplan-Meier method.
The primary goal of this trial is to compare the experimental arm (Arm B) to the standard arm (Arm A).
The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves.
|
Up to 2 years
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Confirmed Response Rate
Ramy czasowe: Up to 2 years
|
Evaluated using RECIST version 1.0.
Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart.
CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD.
The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.
|
Up to 2 years
|
Progression-free Survival
Ramy czasowe: Up to 2 years
|
Progression-free survival is defined as the time from randomization to documentation of disease progression or death, whichever comes first.
Progression is defined as at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
The progression-free survival curves will be compared between the 2 arms using a log-rank test.
|
Up to 2 years
|
Time to Treatment Failure
Ramy czasowe: Up to 2 years
|
Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.
If the patient is considered to be a major treatment violation or is taken off study as a nonprotocol failure, the patient will be censored on the date they are removed from treatment.
The time to treatment failure will be estimated using the method of Kaplan-Meier.
|
Up to 2 years
|
Frequency and Severity of Observed Adverse Effects
Ramy czasowe: Up to 2 years
|
Patients are assessed for Adverse events each cycle using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). The maximum grade for each type of adverse event will be recorded for each patient, and tables will be reviewed to determine adverse event patterns. The number of patients in each arm that reported a grade 3 or higher adverse event and a grade 4 or higher adverse event are reported. A complete listing of all adverse events is reported in the Adverse Events section. |
Up to 2 years
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Krzesło do nauki: George P. Kim, MD, Mayo Clinic
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby Układu Pokarmowego
- Nowotwory
- Nowotwory według lokalizacji
- Choroby układu hormonalnego
- Nowotwory Układu Pokarmowego
- Nowotwory gruczołów dokrewnych
- Choroby trzustki
- Nowotwory trzustki
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Środki przeciwinfekcyjne
- Środki przeciwwirusowe
- Inhibitory enzymów
- Antymetabolity, przeciwnowotworowe
- Antymetabolity
- Środki przeciwnowotworowe
- Środki immunosupresyjne
- Czynniki immunologiczne
- Środki przeciwnowotworowe, immunologiczne
- Inhibitory kinazy białkowej
- Gemcytabina
- Chlorowodorek erlotynibu
- Panitumumab
Inne numery identyfikacyjne badania
- NCCTG-N064B
- NCI-2009-01089 (Identyfikator rejestru: CTRP (Clinical Trials Reporting System))
- CDR0000571863 (Identyfikator rejestru: PDQ (Physician Data Query))
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Rak trzustki
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Aktywny, nie rekrutującyGruczolakorak gruczołu krokowego III stopnia AJCC v7 | Gruczolakorak gruczołu krokowego II stopnia AJCC v7 | Stopień I gruczolakoraka gruczołu krokowego American Joint Committee on Cancer (AJCC) v7Stany Zjednoczone
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Emory UniversityNational Cancer Institute (NCI)WycofanePrognostyczny rak piersi IV stopnia AJCC v8 | Przerzutowy nowotwór złośliwy w mózgu | Przerzutowy rak piersi | Anatomiczny IV stopień raka piersi American Joint Committee on Cancer (AJCC) v8
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Jonsson Comprehensive Cancer CenterZakończonyRak prostaty oporny na kastrację | Przerzutowy rak prostaty | Stadium IVA raka prostaty AJCC v8 | Rak prostaty w stadium IVB AJCC v8 | Rak prostaty w stadium IV American Joint Committee on Cancer (AJCC) v8Stany Zjednoczone
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Jonsson Comprehensive Cancer CenterZakończonyBiochemicznie nawracający rak prostaty | Przerzutowy rak prostaty | Nowotwór złośliwy z przerzutami w kości | Stadium IVA raka prostaty AJCC v8 | Rak prostaty w stadium IVB AJCC v8 | Rak prostaty w stadium IV American Joint Committee on Cancer (AJCC) v8Stany Zjednoczone
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Jonsson Comprehensive Cancer CenterEli Lilly and Company; Genentech, Inc.RekrutacyjnyNiedrobnokomórkowy rak płuc z przerzutami | Oporny na leczenie niedrobnokomórkowy rak płuc | Rak płuca w stadium IV American Joint Committee on Cancer (AJCC) v8 | Rak płuc w stadium IVA AJCC v8 | Rak płuc w stadium IVB AJCC v8Stany Zjednoczone
-
Jonsson Comprehensive Cancer CenterRekrutacyjnyRak prostaty oporny na kastrację | Przerzutowy rak prostaty | Stadium IVA raka prostaty AJCC v8 | Rak prostaty w stadium IVB AJCC v8 | Rak prostaty w stadium IV American Joint Committee on Cancer (AJCC) v8Stany Zjednoczone
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NRG OncologyNational Cancer Institute (NCI)Aktywny, nie rekrutującyAnatomiczny rak piersi IV stadium AJCC v8 | Prognostyczny rak piersi IV stopnia AJCC v8 | Nowotwór złośliwy z przerzutami w kości | Przerzutowy nowotwór złośliwy w węzłach chłonnych | Przerzutowy nowotwór złośliwy w wątrobie | Przerzutowy rak piersi | Przerzutowy nowotwór złośliwy w płucach | Nowotwór... i inne warunkiStany Zjednoczone, Kanada, Arabia Saudyjska, Republika Korei
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National Cancer Institute (NCI)ZakończonyOporny na leczenie złośliwy nowotwór lity | Nawracający złośliwy nowotwór lity | Przerzutowy złośliwy nowotwór lity | Nieoperacyjny lity nowotwór | Nawracający rak drobnokomórkowy płuca | Stopień IIIA Rak drobnokomórkowy płuca AJCC v7 | Etap IIIB Rak drobnokomórkowy płuca AJCC v7 | Rak drobnokomórkowy... i inne warunkiStany Zjednoczone
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Jonsson Comprehensive Cancer CenterBeiGene; Driven To CureWycofanePrzerzutowy rak nerkowokomórkowy | Rak nerkowokomórkowy IV stopnia AJCC v8 | Rak brodawkowaty nerki | Zbieranie raka przewodów | Nieoperacyjny rak nerki | Dziedziczna leiomyomatoza i rak nerkowokomórkowy | Jasnokomórkowy brodawkowaty nowotwór nerki | Dziedziczny rak brodawkowaty nerki | Niesklasyfikowany... i inne warunkiStany Zjednoczone
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Jonsson Comprehensive Cancer CenterAstraZenecaZakończonyRak płaskonabłonkowy jamy ustnej i gardła | Stopień kliniczny III zależny od HPV (p16-dodatni) rak jamy ustnej i gardła AJCC v8 | Stopień kliniczny II, w którym pośredniczy HPV (p16-dodatni) rak jamy ustnej i gardła AJCC v8 | Patologiczny etap I, w którym pośredniczy HPV (p16-dodatni) rak jamy... i inne warunkiStany Zjednoczone
Badania kliniczne na chlorowodorek gemcytabiny
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AbbottRekrutacyjnyDyspepsja funkcjonalnaMalezja, Armenia
-
Janssen Pharmaceutical K.K.Zakończony
-
Mylan Pharmaceuticals IncZakończony
-
Unither Pharmaceuticals, FranceInternational Pharmaceutical Research CenterZakończony
-
Mylan Pharmaceuticals IncZakończonyZdrowyStany Zjednoczone
-
Mylan Pharmaceuticals IncZakończonyZdrowyStany Zjednoczone
-
Lee's Pharmaceutical LimitedZakończony
-
Ventrus Biosciences, IncNieznanyOsoby dorosłe ze szczelinami odbytu.Stany Zjednoczone
-
Tianjin Medical University Cancer Institute and...CSPC Ouyi Pharmaceutical Co., Ltd.Rekrutacyjny
-
Advocate Health CareZakończony