Et studie til at lære om undersøgelsesmedicinen PF-08634404 i kombination med kemoterapi hos voksne deltagere med metastatisk tyktarmskræft
EN INTERVENTIONEL, FAZE 3, DOBBELTBLINDT, RANDOMISERET STUDIE TIL VURDERING AF VIRKNINGEN OG SIKKERHEDEN AF PF-08634404 I KOMBINATION MED KEMOTERAPI VERSUS BEVACIZUMAB I KOMBINATION MED KEMOTERAPI HOS BEHANDLINGSNAIVE DELTAGERE MED METASTASERENDE KOLOREKTALKRÆFT
The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.
To join the study, participants must meet the following conditions:
- Be 18 years or older.
- Have colorectal cancer that has spread to other parts of your body.
- Be in good enough health to receive study treatment.
- Should not be pregnant before starting treatment.
Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.
The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.
- The study is expected to last approximately 33 months for each participant.
- Participants will have regular visits to the study site for treatment, health checks, and tests.
- After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.
- Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studiesteder
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Córdoba, Argentina, X5000AAW
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- Instituto de Investigaciones Clínicas Córdoba S.A.
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La Rioja, Argentina, F5300COE
- Rekruttering
- Fundación CORI para la Investigación y Prevención del Cáncer
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Buenos Aires
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Pergamino, Buenos Aires, Argentina, B2700
- Rekruttering
- Centro de Investigación Pergamino
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Pilar, Buenos Aires, Argentina, 1629
- Rekruttering
- Hospital Universitario Austral
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, 4000
- Rekruttering
- Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
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Queensland
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Buderim, Queensland, Australien, 4556
- Rekruttering
- Sunshine Coast Haematology and Oncology Clinic
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South Australia
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Woodville South, South Australia, Australien, 5011
- Rekruttering
- The Queen Elizabeth Hospital
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Tasmania
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Hobart, Tasmania, Australien, 7000
- Rekruttering
- Icon Cancer Centre Hobart
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Victoria
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Clayton, Victoria, Australien, 3168
- Rekruttering
- Monash Health
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Melbourne, Victoria, Australien, 3000
- Rekruttering
- Peter MacCallum Cancer Centre
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Ghent, Belgien, 9000
- Rekruttering
- AZ Sint-Lucas
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Hainaut
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Charleroi, Hainaut, Belgien, 6060
- Rekruttering
- Grand Hôpital de Charleroi
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Vlaams Brabant
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Leuven, Vlaams Brabant, Belgien, 3000
- Rekruttering
- UZ Leuven
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WEST Vlaanderen
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Roeselare, WEST Vlaanderen, Belgien, 8800
- Rekruttering
- AZ Delta vzw
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Rio de Janeiro, Brasilien, 20230-130
- Rekruttering
- Instituto Nacional de Câncer - INCA
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São Paulo, Brasilien, 05652-900
- Rekruttering
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brasilien, 01221-020
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- Instituto do Cancer Doutor Arnaldo Vieira de Carvalho
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Pernambuco
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Recife, Pernambuco, Brasilien, 50040-000
- Rekruttering
- Hospital de Câncer de Recife
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
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- Hospital de Clínicas de Porto Alegre
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São Paulo
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São Caetano do Sul, São Paulo, Brasilien, 09541-270
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- Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
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- Princess Margaret Cancer Centre
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Toronto, Ontario, Canada, M4N 3M5
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- Sunnybrook Research Institute
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
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- Jewish General Hospital
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Montreal, Quebec, Canada, H4A 3J1
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- McGill University Health Centre
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Aalborg, Danmark, 9000
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- Aalborg University Hospital
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Copenhagen, Danmark, 2100 KBH Ø
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- Rigshospitalet
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Region Syddanmark
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Odense C, Region Syddanmark, Danmark, 5000
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- Odense Universitetshospital
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Vejle, Region Syddanmark, Danmark, 7100
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- Vejle Sygehus
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
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- Ironwood Cancer & Research Centers
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Gilbert, Arizona, Forenede Stater, 85234
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- Banner MD Anderson Cancer Center
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Gilbert, Arizona, Forenede Stater, 85234
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- Banner Gateway Medical Center
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Gilbert, Arizona, Forenede Stater, 85297
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- Ironwood Cancer & Research Centers
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Glendale, Arizona, Forenede Stater, 85306
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- Ironwood Cancer & Research Centers
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Goodyear, Arizona, Forenede Stater, 85395
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- Ironwood Cancer & Research Centers
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Mesa, Arizona, Forenede Stater, 85202
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- Ironwood Cancer & Research Centers
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Mesa, Arizona, Forenede Stater, 85206
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- Ironwood Cancer & Research Centers
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Phoenix, Arizona, Forenede Stater, 85054
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- Mayo Clinic Hospital
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Phoenix, Arizona, Forenede Stater, 85006
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- Banner University Medical Center Phoenix
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Phoenix, Arizona, Forenede Stater, 85028
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- Ironwood Cancer & Research Centers
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Phoenix, Arizona, Forenede Stater, 85054
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- Mayo Clinic Building- Phoenix
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Phoenix, Arizona, Forenede Stater, 85006
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- Banner MD Anderson Cancer Center at Banner University Medical Center- Phoenix
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Phoenix, Arizona, Forenede Stater, 85006
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- Banner MD Anderson Cancer Center
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Scottsdale, Arizona, Forenede Stater, 85259
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- Mayo Clinic
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Scottsdale, Arizona, Forenede Stater, 85260
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- Ironwood Cancer & Research Centers
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Sun City, Arizona, Forenede Stater, 85351
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- Banner Boswell Medical Center
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Sun City, Arizona, Forenede Stater, 85351
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- Banner MD Anderson Cancer Center
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Sun City, Arizona, Forenede Stater, 85351
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- BMDACC Boswell
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Arkansas
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Fayetteville, Arkansas, Forenede Stater, 72703
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- Highlands Oncology Group
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Rogers, Arkansas, Forenede Stater, 72758
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- Highlands Oncology Group
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Springdale, Arkansas, Forenede Stater, 72762
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- Highlands Oncology Group
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California
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Berkeley, California, Forenede Stater, 94702
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- UCSF at Berkeley Outpatient Center
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Berkeley, California, Forenede Stater, 94704
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- Alta Bates Summit Medical Center-Herrick Campus Comprehensive Cancer Center
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Encinitas, California, Forenede Stater, 92024
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- UCSD Medical Center - Encinitas
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Fremont, California, Forenede Stater, 94538
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- Palo Alto Medical Foundation - Fremont Center
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La Jolla, California, Forenede Stater, 92037
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- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
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La Jolla, California, Forenede Stater, 92037
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- UC San Diego Moores Cancer Center
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La Jolla, California, Forenede Stater, 92037
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- UCSD Koman Family Outpatient Pavilion
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Palo Alto, California, Forenede Stater, 94301
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- Palo Alto Medical Foundation - Palo Alto Center
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Roseville, California, Forenede Stater, 95661
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- Roseville Medical Plaza Care Center
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Roseville, California, Forenede Stater, 95661
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- Sutter Medical Center, Sacramento Infusion Center at Roseville
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Sacramento, California, Forenede Stater, 95817
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- University of California, Davis Medical Center
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Sacramento, California, Forenede Stater, 95817
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- University of California, Davis Comprehensive Cancer Center
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San Diego, California, Forenede Stater, 92103
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- UC San Diego Medical Center - Hillcrest
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San Diego, California, Forenede Stater, 92103
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- UC San Diego McGrath Outpatient Pavilion - Hillcrest
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San Diego, California, Forenede Stater, 92127
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- UC San Diego Medical Center - Rancho Bernardo
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San Francisco, California, Forenede Stater, 94158
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- UCSF Medical Center
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San Francisco, California, Forenede Stater, 94107
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- UCSF at China Basin
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San Francisco, California, Forenede Stater, 94115
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- UCSF at Mount Zion
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San Francisco, California, Forenede Stater, 94143
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- UCSF at Parnassus
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San Mateo, California, Forenede Stater, 94401
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- Dorothy Schneider Cancer Center
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San Mateo, California, Forenede Stater, 94401
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- Palo Alto Medical Foundation - San Mateo Care Center
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Santa Rosa, California, Forenede Stater, 95403
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- Airway Drive Care Center
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Sunnyvale, California, Forenede Stater, 94086
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- Palo Alto Medical Foundation - Sunnyvale Center
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Vista, California, Forenede Stater, 92081
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- UCSD Medical Center - Vista
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
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- Rocky Mountain Cancer Centers, LLP
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Boulder, Colorado, Forenede Stater, 80303
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- Rocky Mountain Cancer Centers - Boulder
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Centennial, Colorado, Forenede Stater, 80112
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- Rocky Mountain Cancer Centers, LLP
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Colorado Springs, Colorado, Forenede Stater, 80907
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- Rocky Mountain Cancer Centers, LLP
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Colorado Springs, Colorado, Forenede Stater, 80923
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- Rocky Mountain Cancer Centers, LLP
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Denver, Colorado, Forenede Stater, 80218
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- Rocky Mountain Cancer Centers, LLP
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Denver, Colorado, Forenede Stater, 80220
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- Rocky Mountain Cancer Centers, LLP
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Denver, Colorado, Forenede Stater, 80218
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- Intermountain Health Cancer Center Saint Joseph
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Denver, Colorado, Forenede Stater, 80218
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- Intermountain Health Saint Joseph Hospital - Research Office
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Denver, Colorado, Forenede Stater, 80218
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- Intermountain Health Saint Joseph Hospital
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Englewood, Colorado, Forenede Stater, 80113
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- Rocky Mountain Cancer Centers, LLP
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Greeley, Colorado, Forenede Stater, 80631
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- Banner MD Anderson Cancer Center at North Colorado Medical Center
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Greeley, Colorado, Forenede Stater, 80631
- Rekruttering
- Banner North Colorado Medical Center - Hospital
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Lakewood, Colorado, Forenede Stater, 80228
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- Rocky Mountain Cancer Centers, LLP
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Littleton, Colorado, Forenede Stater, 80120
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- Rocky Mountain Cancer Centers, LLP
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Lone Tree, Colorado, Forenede Stater, 80124
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- Rocky Mountain Cancer Centers, LLP
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Longmont, Colorado, Forenede Stater, 80504
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- Rocky Mountain Cancer Centers, LLP
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Loveland, Colorado, Forenede Stater, 80538
- Rekruttering
- Banner MD Anderson Cancer Center at North Colorado Medical Center - Loveland Campus
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Loveland, Colorado, Forenede Stater, 80538
- Rekruttering
- Banner North Colorado Medical Center - Loveland Campus (Hospital)
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Pueblo, Colorado, Forenede Stater, 81003
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- Rocky Mountain Cancer Centers, LLP
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Thornton, Colorado, Forenede Stater, 80260
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- Rocky Mountain Cancer Centers, LLP
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Connecticut
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Stamford, Connecticut, Forenede Stater, 06904
- Ikke rekrutterer endnu
- Stamford Hospital
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Florida
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Bonita Springs, Florida, Forenede Stater, 34135
- Rekruttering
- Florida Cancer Specialists
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Bradenton, Florida, Forenede Stater, 34211
- Rekruttering
- Florida Cancer Specialists
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Brandon, Florida, Forenede Stater, 33511
- Rekruttering
- Comprehensive Hematology Oncology
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Cape Coral, Florida, Forenede Stater, 33909
- Rekruttering
- Florida Cancer Specialists
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Coral Springs, Florida, Forenede Stater, 33065
- Rekruttering
- BRCR Global - Coral Springs
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Fort Myers, Florida, Forenede Stater, 33908
- Rekruttering
- Florida Cancer Specialists
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Fort Myers, Florida, Forenede Stater, 33905
- Rekruttering
- Florida Cancer Specialists
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Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Mayo Clinic
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Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Mayo Clinic Pharmacy
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Largo, Florida, Forenede Stater, 33770
- Rekruttering
- Comprehensive Hematology Oncology
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Melbourne, Florida, Forenede Stater, 32935
- Rekruttering
- Cancer Care Centers of Brevard, Inc.
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N. Venice, Florida, Forenede Stater, 34275
- Rekruttering
- Florida Cancer Specialists
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Naples, Florida, Forenede Stater, 34102
- Rekruttering
- Florida Cancer Specialists
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Orange City, Florida, Forenede Stater, 32763
- Rekruttering
- Mid Florida Hematology and Oncology Center
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Palm Bay, Florida, Forenede Stater, 32909
- Rekruttering
- Cancer Care Centers of Brevard, Inc.
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Palm Harbor, Florida, Forenede Stater, 34683
- Rekruttering
- Comprehensive Hematology Oncology
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Port Charlotte, Florida, Forenede Stater, 33980
- Rekruttering
- Florida Cancer Specialists
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Rockledge, Florida, Forenede Stater, 32955
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- Cancer Care Centers of Brevard, Inc.
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Sarasota, Florida, Forenede Stater, 34236
- Rekruttering
- Florida Cancer Specialists
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St. Petersburg, Florida, Forenede Stater, 33709
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- Comprehensive Hematology Oncology
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St. Petersburg, Florida, Forenede Stater, 33701
- Rekruttering
- Comprehensive Hematology Oncology
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Trinity, Florida, Forenede Stater, 34655
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- Comprehensive Hematology Oncology
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Georgia
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Athens, Georgia, Forenede Stater, 30607
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- University Cancer & Blood Center, LLC
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Idaho
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Boise, Idaho, Forenede Stater, 83706
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- Saint Alphonsus Regional Medical Center
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Nampa, Idaho, Forenede Stater, 83687
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- Saint Alphonsus Nampa Cancer Care Center
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Illinois
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Arlington Heights, Illinois, Forenede Stater, 60005
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- Illinois Cancer Specialists
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Bloomington, Illinois, Forenede Stater, 61704
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- Illinois CancerCare - Bloomington
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Chicago, Illinois, Forenede Stater, 60631
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- Illinois Cancer Specialists
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Galesburg, Illinois, Forenede Stater, 61401
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- Illinois CancerCare - Galesburg
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Hinsdale, Illinois, Forenede Stater, 60521
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- Hope and Healing Clinical Research LLC
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Morris, Illinois, Forenede Stater, 60450
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- Hope and Healing Clinical Research LLC
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New Lenox, Illinois, Forenede Stater, 60451
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- Hope and Healing Clinical Research LLC
-
Niles, Illinois, Forenede Stater, 60714
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- Illinois Cancer Specialists
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Ottawa, Illinois, Forenede Stater, 61350
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- Illinois CancerCare-Ottawa-Fox River Cancer Center
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Pekin, Illinois, Forenede Stater, 61554
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- Illinois CancerCare-Pekin
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Peoria, Illinois, Forenede Stater, 61615
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- Illinois Cancer Care
-
Peru, Illinois, Forenede Stater, 61354
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- Illinois CancerCare-Peru - Valley Regional Cancer Center
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Washington, Illinois, Forenede Stater, 61571
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- Illinois CancerCare-Washington
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46237
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- Franciscan Health
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Mooresville, Indiana, Forenede Stater, 46158
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- Franciscan Health Mooresville
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Kentucky
-
Elizabethtown, Kentucky, Forenede Stater, 42701
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- Baptist Health Hardin
-
Frankfort, Kentucky, Forenede Stater, 40601
- Rekruttering
- Frankfort BHMG Medical Oncology Office
-
Lexington, Kentucky, Forenede Stater, 40536
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- University of Kentucky/Markey Cancer Center
-
Lexington, Kentucky, Forenede Stater, 40503
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- Baptist Health Lexington
-
Lexington, Kentucky, Forenede Stater, 40536
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- University of Kentucky Medical Center
-
Lexington, Kentucky, Forenede Stater, 40509
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- Baptist Health Hamburg
-
Lexington, Kentucky, Forenede Stater, 40503
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- Baptist Health Richmond
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Louisville, Kentucky, Forenede Stater, 40207
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- Baptist Health Louisville
-
Louisville, Kentucky, Forenede Stater, 40245
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- UofL Health Medical Center Northeast
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Louisville, Kentucky, Forenede Stater, 40202
- Ikke rekrutterer endnu
- Norton Cancer Institute, Downtown
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Louisville, Kentucky, Forenede Stater, 40202
- Ikke rekrutterer endnu
- Norton Hospital
-
Louisville, Kentucky, Forenede Stater, 40217
- Ikke rekrutterer endnu
- Norton Audubon Hospital
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Louisville, Kentucky, Forenede Stater, 40241
- Ikke rekrutterer endnu
- Norton Brownsboro Hospital
-
Louisville, Kentucky, Forenede Stater, 40202
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- UofL Health Brown Cancer Center
-
Louisville, Kentucky, Forenede Stater, 40217
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- Norton Cancer Institute, Audubon Hospital Campus
-
Louisville, Kentucky, Forenede Stater, 40223
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- Baptist Health EastPoint
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Louisville, Kentucky, Forenede Stater, 40241
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- Norton Cancer Institute Brownsboro Hospital Campus
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Richmond, Kentucky, Forenede Stater, 40475
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- Richmond BHMG Medical Oncology Clinic
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Maine
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Topsham, Maine, Forenede Stater, 04086
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- New England Cancer Specialists
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Westbrook, Maine, Forenede Stater, 04092
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- New England Cancer Specialists
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Maryland
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Baltimore, Maryland, Forenede Stater, 21204
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- Greater Baltimore Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
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- Dana-Farber Cancer Institute (DFCI)
-
Boston, Massachusetts, Forenede Stater, 02115
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- Brigham and Women's Hospital (BWH)
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Foxborough, Massachusetts, Forenede Stater, 02035
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- Dana-Farber Brigham Cancer Center - Foxborough
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Milford, Massachusetts, Forenede Stater, 01757
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- Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
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Newton, Massachusetts, Forenede Stater, 02467
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- Dana-Farber Cancer Institute -Chestnut Hill
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Michigan
-
Big Rapids, Michigan, Forenede Stater, 49307
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- The Cancer & Hematology Centers
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Grand Rapids, Michigan, Forenede Stater, 49503
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- The Cancer & Hematology Centers
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Grand Rapids, Michigan, Forenede Stater, 49546
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- The Cancer & Hematology Centers
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Holland, Michigan, Forenede Stater, 49424
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- The Cancer & Hematology Centers
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Norton Shores, Michigan, Forenede Stater, 49444
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- The Cancer & Hematology Centers
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Minnesota
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Marshall, Minnesota, Forenede Stater, 56258
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- Avera Cancer Institute- Marshall
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Rochester, Minnesota, Forenede Stater, 55905
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- Mayo Clinic
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Rochester, Minnesota, Forenede Stater, 55905
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- Mayo Clinic Cancer Center Outpatient Pharmacy
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Rochester, Minnesota, Forenede Stater, 55902
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Rochester, Minnesota, Forenede Stater, 55902
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- Mayo Clinic Pharmacy
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Rochester, Minnesota, Forenede Stater, 55905
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Rochester, Minnesota, Forenede Stater, 55905
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- St. Marys Campus
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68516
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- Cancer Partners of Nebraska
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Nevada
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Henderson, Nevada, Forenede Stater, 89074
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- Comprehensive Cancer Centers of Nevada
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Henderson, Nevada, Forenede Stater, 89052
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- Comprehensive Cancer Centers Of Nevada
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Las Vegas, Nevada, Forenede Stater, 89169
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- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Forenede Stater, 89148
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- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Forenede Stater, 89128
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- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Forenede Stater, 89144
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- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Forenede Stater, 89106
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- Comprehensive Cancer Centers of Nevada
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Reno, Nevada, Forenede Stater, 89502
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- Renown Regional Medical Center
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Reno, Nevada, Forenede Stater, 89502
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- Renown Health Medical Oncology
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131
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- University of New Mexico Comprehensive Cancer Center
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New York
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Albany, New York, Forenede Stater, 12206
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- NYOH Albany Cancer Center
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Auburn, New York, Forenede Stater, 13021
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- Hematology-Oncology Associates of Central New York, PC
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Babylon, New York, Forenede Stater, 11702
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- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
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Brooklyn, New York, Forenede Stater, 11210
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- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
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Camillus, New York, Forenede Stater, 13031
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- Hematology-Oncology Associates of Central New York, PC
-
Clifton Park, New York, Forenede Stater, 12065
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- New York Oncology Hematology - Clifton Park Cancer Center
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East Syracuse, New York, Forenede Stater, 13057
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- Hematology-Oncology Associates of Central New York, PC
-
New Hyde Park, New York, Forenede Stater, 11042
- Rekruttering
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
-
New York, New York, Forenede Stater, 10028
- Rekruttering
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
-
Nyack, New York, Forenede Stater, 10960
- Rekruttering
- Hematology Oncology Associates of Rockland
-
Patchogue, New York, Forenede Stater, 11772
- Rekruttering
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
-
Port Jefferson Station, New York, Forenede Stater, 11776
- Rekruttering
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
-
Riverhead, New York, Forenede Stater, 11901
- Rekruttering
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
-
Shirley, New York, Forenede Stater, 11967
- Rekruttering
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
-
The Bronx, New York, Forenede Stater, 10469
- Rekruttering
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
-
-
North Carolina
-
Cary, North Carolina, Forenede Stater, 27518
- Rekruttering
- Duke Cancer Center Cary
-
Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke Cancer Center
-
Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke Cancer Center - Investigational Chemotherapy Service
-
Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke University Hospital - Vascular Interventional Radiology
-
Raleigh, North Carolina, Forenede Stater, 27609
- Rekruttering
- Duke Cancer Center Raleigh
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45245
- Rekruttering
- Oncology Hematology Care - Eastgate
-
Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
-
Fairfield, Ohio, Forenede Stater, 45014
- Rekruttering
- Oncology Hematology Care Clinical Trials, LLC
-
-
Oregon
-
Albany, Oregon, Forenede Stater, 97321
- Rekruttering
- Oncology Associates of Oregon, P.C.
-
Clackamas, Oregon, Forenede Stater, 97015
- Rekruttering
- Kaiser Permanente Sunnyside Medical Center
-
Corvallis, Oregon, Forenede Stater, 97330
- Rekruttering
- Oncology Associates of Oregon, P.C.
-
Eugene, Oregon, Forenede Stater, 97401
- Rekruttering
- Oncology Associates of Oregon, P.C.
-
Hillsboro, Oregon, Forenede Stater, 97124
- Rekruttering
- Kaiser Permanente Westside Medical Center
-
Portland, Oregon, Forenede Stater, 97227
- Rekruttering
- Kaiser Permanente Interstate Medical Office Central
-
Springfield, Oregon, Forenede Stater, 97477
- Rekruttering
- Oncology Associates of Oregon, P.C.
-
-
South Dakota
-
Aberdeen, South Dakota, Forenede Stater, 57401
- Rekruttering
- Avera Cancer Institute- Aberdeen
-
Mitchell, South Dakota, Forenede Stater, 57301
- Rekruttering
- Avera Cancer Institute- Mitchell
-
Pierre, South Dakota, Forenede Stater, 57501
- Rekruttering
- Avera Cancer Institute- Pierre
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Rekruttering
- Avera Cancer Institute
-
Yankton, South Dakota, Forenede Stater, 57078
- Rekruttering
- Avera Cancer Institute - Yankton
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Henry-Joyce Cancer Clinic
-
-
Texas
-
Abilene, Texas, Forenede Stater, 79606
- Rekruttering
- Texas Oncology - West Texas
-
Amarillo, Texas, Forenede Stater, 79124
- Rekruttering
- Texas Oncology - West Texas
-
Beaumont, Texas, Forenede Stater, 77702
- Rekruttering
- Texas Oncology - Gulf Coast
-
Denison, Texas, Forenede Stater, 75020
- Rekruttering
- Texas Oncology - Northeast Texas
-
Denton, Texas, Forenede Stater, 76201
- Rekruttering
- Texas Oncology - Northeast Texas
-
El Paso, Texas, Forenede Stater, 79902
- Rekruttering
- Texas Oncology - West Texas
-
El Paso, Texas, Forenede Stater, 79915
- Rekruttering
- Texas Oncology - West Texas
-
El Paso, Texas, Forenede Stater, 79938
- Rekruttering
- Texas Oncology - West Texas
-
Flower Mound, Texas, Forenede Stater, 75028
- Rekruttering
- Texas Oncology - Northeast Texas
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Oncology Consultants P.A.
-
Houston, Texas, Forenede Stater, 77024
- Rekruttering
- Texas Oncology - Gulf Coast
-
Houston, Texas, Forenede Stater, 77054
- Rekruttering
- Texas Oncology - Gulf Coast
-
Houston, Texas, Forenede Stater, 77070
- Rekruttering
- Texas Oncology - Gulf Coast
-
Houston, Texas, Forenede Stater, 77008
- Rekruttering
- Oncology Consultants P.A.
-
Houston, Texas, Forenede Stater, 77024
- Rekruttering
- Oncology Consultants P.A.
-
Houston, Texas, Forenede Stater, 77098
- Rekruttering
- Radnet/Houston Medical Imaging
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Memorial Hermann Hospital-TMC (IP Storage)
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- UTHealth/Memorial Hermann Cancer Center - Texas Medical Center
-
Humble, Texas, Forenede Stater, 77338
- Rekruttering
- Texas Oncology - Gulf Coast
-
Irving, Texas, Forenede Stater, 75063
- Rekruttering
- US Oncology Investigational Products Center (IPC)
-
Irving, Texas, Forenede Stater, 75063
- Rekruttering
- US Oncology Investigational Products Center
-
Longview, Texas, Forenede Stater, 75601
- Rekruttering
- Texas Oncology - Northeast Texas
-
Midland, Texas, Forenede Stater, 79701
- Rekruttering
- Texas Oncology - West Texas
-
Odessa, Texas, Forenede Stater, 79761
- Rekruttering
- Texas Oncology - West Texas
-
Pearland, Texas, Forenede Stater, 77584
- Rekruttering
- Texas Oncology - Gulf Coast
-
Sugar Land, Texas, Forenede Stater, 77479
- Rekruttering
- Texas Oncology - Gulf Coast
-
Temple, Texas, Forenede Stater, 76508
- Rekruttering
- Baylor Scott & White Medical Center-Temple
-
The Woodlands, Texas, Forenede Stater, 77380
- Rekruttering
- Texas Oncology - Gulf Coast
-
Tyler, Texas, Forenede Stater, 75702
- Rekruttering
- Texas Oncology - Northeast Texas
-
Wichita Falls, Texas, Forenede Stater, 76310
- Rekruttering
- Texas Oncology - West Texas
-
-
Virginia
-
Arlington, Virginia, Forenede Stater, 22201
- Rekruttering
- Virginia Cancer Specialists, PC
-
Blacksburg, Virginia, Forenede Stater, 24060
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
-
Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Virginia Cancer Specialists, PC
-
Low Moor, Virginia, Forenede Stater, 24457
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
-
Manassas, Virginia, Forenede Stater, 20110
- Rekruttering
- Virginia Cancer Specialists, PC
-
Mechanicsville, Virginia, Forenede Stater, 23116
- Rekruttering
- Virginia Cancer Institute
-
Midlothian, Virginia, Forenede Stater, 23112
- Rekruttering
- Virginia Cancer Institute
-
Petersburg, Virginia, Forenede Stater, 23805
- Rekruttering
- Virginia Cancer Institute
-
Reston, Virginia, Forenede Stater, 20190
- Rekruttering
- Virginia Cancer Specialists, PC
-
Richmond, Virginia, Forenede Stater, 23229
- Rekruttering
- Virginia Cancer Institute
-
Richmond, Virginia, Forenede Stater, 23235
- Rekruttering
- Virginia Cancer Institute
-
Roanoke, Virginia, Forenede Stater, 24014
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
-
Salem, Virginia, Forenede Stater, 24153
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
-
Woodbridge, Virginia, Forenede Stater, 22191
- Rekruttering
- Virginia Cancer Specialists, PC
-
Wytheville, Virginia, Forenede Stater, 24382
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
-
-
Washington
-
Bonney Lake, Washington, Forenede Stater, 98391
- Rekruttering
- Northwest Medical Specialties, PLLC
-
Edmonds, Washington, Forenede Stater, 98026
- Rekruttering
- Swedish Cancer Institute - Edmonds Campus
-
Edmonds, Washington, Forenede Stater, 98026
- Rekruttering
- Swedish Medical Center - Edmonds
-
Federal Way, Washington, Forenede Stater, 98003
- Rekruttering
- Northwest Medical Specialties, PLLC
-
Gig Harbor, Washington, Forenede Stater, 98332
- Rekruttering
- Northwest Medical Specialties, PLLC
-
Issaquah, Washington, Forenede Stater, 98029
- Rekruttering
- Swedish Cancer Institute - Issaquah Campus
-
Kennewick, Washington, Forenede Stater, 99336
- Ikke rekrutterer endnu
- Kadlec Clinic Hematology and Oncology
-
Kennewick, Washington, Forenede Stater, 99336
- Ikke rekrutterer endnu
- Tri-Cities Cancer Center
-
Puyallup, Washington, Forenede Stater, 98373
- Rekruttering
- Northwest Medical Specialties, PLLC
-
Richland, Washington, Forenede Stater, 99352
- Ikke rekrutterer endnu
- Kadlec Outpatient Imaging Center
-
Richland, Washington, Forenede Stater, 99352
- Ikke rekrutterer endnu
- Kadlec Regional Medical Center
-
Seattle, Washington, Forenede Stater, 98195
- Rekruttering
- University of Washington Medical Center
-
Seattle, Washington, Forenede Stater, 98104
- Rekruttering
- Swedish Cancer Institute
-
Seattle, Washington, Forenede Stater, 98122
- Rekruttering
- Swedish Medical Center
-
Seattle, Washington, Forenede Stater, 98109
- Rekruttering
- Fred Hutchinson Cancer Center
-
Tacoma, Washington, Forenede Stater, 98405
- Rekruttering
- Northwest Medical Specialties, PLLC
-
-
-
-
-
Brest, Frankrig, 29200
- Rekruttering
- CHU Brest, Hopital La Cavale Blanche
-
Dijon, Frankrig, 21079 Cedex
- Rekruttering
- Centre Georges-François Leclerc health establishment, centre or care home
-
Lille, Frankrig, 59037
- Rekruttering
- CHU de Lille, Hopital Claude Huriez
-
Paris, Frankrig, 75010
- Rekruttering
- Hôpital Saint-Louis
-
Paris, Frankrig, 75015
- Rekruttering
- Hôpital Européen Georges Pompidou
-
Poitiers, Frankrig, 86021
- Rekruttering
- Centre Hospitalier Universitaire de Poitiers
-
-
Val-de-marne
-
Villejuif, Val-de-marne, Frankrig, 94800
- Ikke rekrutterer endnu
- Institut Gustave Roussy
-
-
Île-de-France Region
-
Créteil, Île-de-France Region, Frankrig, 94000
- Rekruttering
- Henri Mondor Hospital
-
-
-
-
HA Merkaz
-
Petah Tikva, HA Merkaz, Israel, 4941492
- Rekruttering
- Rabin Medical Center
-
Ramat Gan, HA Merkaz, Israel, 5265601
- Rekruttering
- Sheba Medical Center
-
-
HA Tsafon
-
Haifa, HA Tsafon, Israel, 3109601
- Rekruttering
- Rambam Health Care Campus
-
-
Jerusalem
-
Jerusalem, Jerusalem, Israel, 9112001
- Rekruttering
- Hadassah Medical Center
-
-
TELL ABĪB
-
Tel Aviv, TELL ABĪB, Israel, 6423906
- Rekruttering
- Sourasky Medical Center
-
-
-
-
-
Florence, Italien, 50134
- Ikke rekrutterer endnu
- Azienda Ospedaliera Universitaria Careggi
-
Milan, Italien, 20141
- Rekruttering
- Istituto Europeo di Oncologia IRCCS
-
-
Lecce
-
Tricase, Lecce, Italien, 73039
- Rekruttering
- Pia Fondazione Di Culto E Di Religione Card. G. Panico
-
-
ROME
-
Roma, ROME, Italien, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
-
-
Veneto
-
Padova, Veneto, Italien, 35128
- Rekruttering
- Istituto Oncologico Veneto IRCCS
-
-
-
-
-
Fukuoka, Japan, 812-8582
- Rekruttering
- Kyushu University Hospital
-
Osaka, Japan, 541-8567
- Rekruttering
- Osaka Prefectural Hospital Organization Osaka International Cancer Institute
-
Osaka, Japan, 540-0006
- Rekruttering
- National Hospital Organization Osaka Medical Center
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 464-8681
- Rekruttering
- Aichi Cancer Center Hospital
-
-
Chiba
-
Chiba, Chiba, Japan, 260-8717
- Rekruttering
- Chiba cancer center
-
Kashiwa, Chiba, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East
-
-
Kanagawa
-
Yokohama, Kanagawa, Japan, 241-8515
- Rekruttering
- Kanagawa cancer center
-
-
Saitama
-
Hidaka, Saitama, Japan, 350-1298
- Rekruttering
- Saitama Medical University International Medical Center
-
Kitaadachi-gun, Saitama, Japan, 362-0806
- Rekruttering
- Saitama Prefectural Cancer Center
-
-
Shizuoka
-
Nagaizumi-cho, Shizuoka, Japan, 411-8777
- Rekruttering
- Shizuoka Cancer Center
-
-
Tokyo
-
Koto-ku, Tokyo, Japan, 135-8550
- Rekruttering
- The Cancer Institute Hospital of JFCR
-
-
-
-
Anhui
-
Hefei, Anhui, Kina, 230031
- Rekruttering
- Anhui Provincial Cancer Hospital
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100730
- Rekruttering
- Peking Union Medical College Hospital
-
Beijing, Beijing Municipality, Kina, 102627
- Rekruttering
- Peking University First Hospital
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina, 400030
- Rekruttering
- Chongqing University Cancer Hospital
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350001
- Rekruttering
- Fujian Medical University Union Hospital
-
Xiamen, Fujian, Kina, 361003
- Ikke rekrutterer endnu
- The First Affiliated hospital of Xiamen University
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510060
- Rekruttering
- Sun Yat-sen University Cancer Center
-
Guangzhou, Guangdong, Kina, 510555
- Rekruttering
- Sun Yat-sen University Cancer Center
-
Guangzhou, Guangdong, Kina, 510655
- Rekruttering
- The Sixth Affiliated Hospital, Sun Yet-sen University
-
Meizhou, Guangdong, Kina, 514031
- Rekruttering
- Meizhou People's Hospital
-
-
Guangxi
-
Nanning, Guangxi, Kina, 530200
- Rekruttering
- Guangxi Medical University Cancer Hospital
-
-
Heilongjiang
-
Harbin, Heilongjiang, Kina, 150081
- Rekruttering
- Harbin Medical University Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, Kina, 430030
- Rekruttering
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
-
Wuhan, Hubei, Kina, 430048
- Rekruttering
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
-
-
Hunan
-
Changsha, Hunan, Kina, 410013
- Rekruttering
- Hunan Cancer Hospital
-
Changsha, Hunan, Kina, 410013
- Rekruttering
- The Third Xiangya Hospital of Central South University
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210008
- Rekruttering
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330200
- Rekruttering
- The First Affiliated Hospital of Nanchang University
-
-
Shandong
-
Jinan, Shandong, Kina, 250117
- Rekruttering
- Shandong Cancer Hospital
-
Qingdao, Shandong, Kina, 266031
- Rekruttering
- The Affiliated Hospital of Qingdao University
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 201315
- Rekruttering
- Fudan University Shanghai Cancer Center
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610213
- Rekruttering
- Sichuan Cancer hospital
-
Mianyang, Sichuan, Kina, 621000
- Rekruttering
- Mianyang Central Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310017
- Rekruttering
- The second Affiliated Hospital of College of Medicine, Zhejiang University
-
-
-
-
-
Koszalin, Polen, 75-581
- Rekruttering
- Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
-
Krakow, Polen, 30-727
- Rekruttering
- Pratia MCM Krakow
-
Opole, Polen, 45-061
- Rekruttering
- SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
-
Poznan, Polen, 60-192
- Rekruttering
- Pratia Poznań
-
-
Silesian Voivodeship
-
Katowice, Silesian Voivodeship, Polen, 40-519
- Rekruttering
- Pratia Onkologia Katowice
-
-
-
-
-
Mayagüez, Puerto Rico, 00680
- Rekruttering
- Pan American Center for Oncology Trials - Mayaguez
-
Rio Piedras, Puerto Rico, 00935
- Rekruttering
- Pan American Center for Oncology Trials, LLC
-
San Juan, Puerto Rico, 00909
- Rekruttering
- Pan American Center for Oncology Trials, LLC
-
San Juan, Puerto Rico, 00907
- Rekruttering
- Pan American Center for Oncology Trials, LLC - Centro Europa Office
-
-
-
-
-
Barcelona, Spanien, 08036
- Rekruttering
- Hospital Clinic de Barcelona
-
Barcelona, Spanien, 08029
- Rekruttering
- CETIR
-
Córdoba, Spanien, 14004
- Rekruttering
- Hospital Universitario Reina Sofia
-
Málaga, Spanien, 29011
- Rekruttering
- Hospital Regional Universitario de Malaga (Hospital Civil)
-
Valencia, Spanien, 46009
- Rekruttering
- Instituto Valenciano de Oncología (IVO)
-
Zaragoza, Spanien, 50009
- Rekruttering
- Hospital Universitario Miguel Servet
-
Zaragoza, Spanien, 50006
- Rekruttering
- Zentro Diagnostico Avanzado
-
-
A Coruña [LA Coruña]
-
Santiago de Compostela, A Coruña [LA Coruña], Spanien, 15706
- Rekruttering
- CHUS - Hospital Clinico Universitario
-
-
Andalusia
-
Málaga, Andalusia, Spanien, 29016
- Rekruttering
- Clínica Radiológica HLA Mario Gallegos
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spanien, 08908
- Rekruttering
- Institut Català d'Oncologia - L'Hospitalet
-
-
Barcelona [barcelona]
-
Barcelona, Barcelona [barcelona], Spanien, 08035
- Rekruttering
- Hospital Universitari Vall d'Hebron
-
-
Cádiz
-
Jerez de la Frontera, Cádiz, Spanien, 11407
- Rekruttering
- Hospital Jerez de la Frontera
-
-
Madrid, Comunidad de
-
Madrid, Madrid, Comunidad de, Spanien, 28034
- Rekruttering
- Hospital Universitario Ramón y Cajal
-
-
-
-
-
Kaohsiung City, Taiwan, 807
- Rekruttering
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Kaohsiung City, Taiwan, 83301
- Rekruttering
- Chang Gung Memorial Hospital at Kaohsiung
-
Tainan, Taiwan, 704
- Rekruttering
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 10002
- Rekruttering
- National Taiwan University Hospital
-
Taipei, Taiwan, 11217
- Rekruttering
- Taipei Veterans General Hospital
-
Taoyuan, Taiwan, 333
- Rekruttering
- Chang Gung Medical Foundation-Linkou Branch
-
-
-
-
-
Berlin, Tyskland, 12559
- Rekruttering
- DRK Kliniken Berlin - Köpenick
-
Berlin, Tyskland, 13353
- Rekruttering
- Charité Universitaetsmedizin Berlin - Campus Mitte
-
Dresden, Tyskland, 01307
- Rekruttering
- Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
-
Dresden, Tyskland, 01307
- Rekruttering
- Universitätsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
-
Hamburg, Tyskland, 22763
- Rekruttering
- Asklepios Altona
-
München, Tyskland, 81737
- Rekruttering
- Muenchen Klinik Neuperlach
-
-
Hesse
-
Frankfurt am Main, Hesse, Tyskland, 60488
- Rekruttering
- Krankenhaus Nordwest GmbH
-
-
North Rhine-Westphalia
-
Essen, North Rhine-Westphalia, Tyskland, 45147
- Rekruttering
- Universitaetsklinikum Essen
-
-
Saxony
-
Leipzig, Saxony, Tyskland, 04103
- Rekruttering
- Universitäres Krebszentrum Leipzig (UCCL), UKL AöR
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histological or cytological confirmed colorectal adenocarcinoma.
- Evidence of Stage IV metastatic disease.
- No prior systemic therapy for metastatic disease.
- Eastern Cooperative Oncology Group performance status (ECOG) 0-1
- At least one measurable lesion according to RECIST 1.1 per Investigator assessment.
- Adequate hepatic, liver, and renal function
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Locally confirmed BRAF V600E mutation
- Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer
- Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
- Clinically significant risk of hemorrhage or fistula
- Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
- Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
- Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
- Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: PF-08634404 + Chemotherapy
Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy. |
Solution for infusion Injection for intravenous use |
|
Aktiv komparator: Bevacizumab + Chemotherapy
Participants will receive bevacizumab IV in combination with Chemotherapy. |
Injection for intravenous use Injection for intravenous use
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
Tidsramme: Approximately 4 years
|
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by BICR per RECIST 1.1, or death due to any cause, whichever occurs first. |
Approximately 4 years
|
|
Overall survival (OS)
Tidsramme: Approximately 4 years
|
Overall survival defined as the time from the date of randomization to the date of death due to any cause. |
Approximately 4 years
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Antal deltagere med behandlingsrelaterede bivirkninger (AEs) og alvorlige bivirkninger (SAEs)
Tidsramme: I op til 90 dage efter sidste studieintervention; Cirka 4 år
|
I op til 90 dage efter sidste studieintervention; Cirka 4 år
|
|
|
Antal deltagere med kliniske laboratorieabnormiteter
Tidsramme: I op til 90 dage efter sidste studieintervention; cirka 4 år
|
I op til 90 dage efter sidste studieintervention; cirka 4 år
|
|
|
Farmakokinetik (PK): Serumkoncentration af PF-08634404
Tidsramme: Cirka 21 måneder
|
Cirka 21 måneder
|
|
|
PFS per RECIST 1.1 by investigator assessment
Tidsramme: Approximately 4 years
|
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST 1.1, or death due to any cause, whichever occurs first. |
Approximately 4 years
|
|
Objective Response Rate (ORR) by BICR
Tidsramme: Approximately 4 years
|
The proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1. |
Approximately 4 years
|
|
Objective Response Rate (ORR) by investigator
Tidsramme: Approximately 4 years
|
The proportion of participants who have a confirmed CR or PR, as best overall response assessed by investigator as per RECIST 1.1. |
Approximately 4 years
|
|
Duration of Response (DOR) by BICR
Tidsramme: Approximately 4 years
|
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by BICR assessment per RECIST 1.1, or death due to any cause, whichever occurs first. |
Approximately 4 years
|
|
DOR by investigator
Tidsramme: Approximately 4 years
|
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by Investigator per RECIST 1.1, or death due to any cause, whichever occurs first. |
Approximately 4 years
|
|
PFS2 (PFS after next-line therapy) by investigator
Tidsramme: Approximately 4 years
|
PFS2 is defined as the time from the date of randomization to the date of second objective disease progression or death due to any cause, whichever occurs first. Second objective disease progression is PD after the start of subsequent anticancer therapy (excluding curative surgery) as assessed by the investigator. |
Approximately 4 years
|
|
Immunogenicity: Incidence of positive Anti-Drug Antibody (ADA)
Tidsramme: Approximately 21 months
|
To characterize the immunogenicity of PF-08634404 |
Approximately 21 months
|
|
Mean scores and Change from baseline in the global health status/quality of life (QoL) score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Tidsramme: Approximately 4 years
|
The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials. |
Approximately 4 years
|
|
Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29
Tidsramme: Approximately 4 years
|
The EORTC QLQ-CR29 is a supplemental colorectal cancer-specific module with measures of symptoms associated with colorectal cancer. |
Approximately 4 years
|
|
Time to definitive deterioration (TTdD) in the global health status/QoL score on the EORTC QLQ-C30
Tidsramme: Approximately 4 years
|
TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery. |
Approximately 4 years
|
|
Time to definitive deterioration (TTdD) in participant reported function and symptoms per EORTC QLQ-CR29
Tidsramme: Approximately 4 years
|
TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery. |
Approximately 4 years
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer
- Neoplastiske processer
- Patologiske tilstande, tegn og symptomer
- Gastrointestinale sygdomme
- Sygdomme i fordøjelsessystemet
- Tyktarmssygdomme
- Kolorektale neoplasmer
- Colon neoplasmer
- Neoplasma Metastase
- Gastrointestinale neoplasmer
- Intestinale neoplasmer
- Tarmsygdomme
- Neoplasmer i fordøjelsessystemet
- Neoplasmer efter sted
- Endetarmssygdomme
- Aminosyrer, peptider og proteiner
- Proteiner
- Terapeutik
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Bevacizumab
- Lægemiddelterapi
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- C6461003
- 2025-523521-18-00 (Ctis)
- Symbiotic-GI-03 (Anden identifikator: Pfizer)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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