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NCT07228832

Estudio de fase III con ivonescimab o bevacizumab en combinación con FOLFOX en pacientes con cáncer colorrectal metastásico.

Reclutando Fase 3

Descripción

Un estudio clínico aleatorizado, controlado con un grupo activo, doble ciego, multicéntrico, de fase 3, para evaluar ivonescimab en combinación con mFOLFOX6 (oxaliplatino, leucovorina y 5-fluorouracilo) frente a bevacizumab en combinación con FOLFOX para el tratamiento de primera línea del cáncer colorrectal metastásico (HARMONi-GI3).

Evidencia de la diana molecular en cáncer colorrectal (BRAF)

Fármaco / régimen ORR SLP (m) Fase / n Evidencia Fuente
FOLFIRI-cetuximab then mFOLFOX6-bevacizumab este fármaco 82.4% — Phase 3 / n=131 1 PMID 41980919
Standard care (quimioterapia ± bevacizumab) este fármaco — 7.1 Phase 3 1 PMID 40444708 · 2026
OPTIMOX-bevacizumab then FOLFIRI-bevacizumab then EGFR monoclonal anticuerpo +/- irinotecan este fármaco 65.4% — Phase 3 / n=132 1 PMID 41980919
Standard care (quimioterapia con o sin bevacizumab) este fármaco — 7.1 Phase 3 1 PMID 40444708
FOLFOXIRI + Bevacizumab este fármaco 56% 7.5 Phase 3 / n=28 2A PMID 33539752 · 2019
FOLFOXIRI + Bevacizumab este fármaco 56% 7.5 Phase 3 / n=28 2A PMID 30514390 · 2019

Criterios de Elegibilidad

Criterios de inclusión:

1. Puntuación en la escala de ECOG de 0 o 1.

2. Esperanza de vida prevista ≥ 6 meses.

3. Pacientes con CRC metastásico confirmado histológica o citológicamente.

4. Sin terapia sistémica previa para CRC metastásico.

5. Al menos 1 lesión no cerebral medible.

Criterios de exclusión:

1. Enfermedad con inestabilidad de microsatélites alta (MSI-H) o deficiencia en la reparación de desajustes (dMMR).

2. Estado mutante conocido de BRAF V600E.

3. Presencia actual de manifestaciones radiográficas o clínicas significativas de obstrucción gastrointestinal (GI).

4. Ascitis que requiera paracentesis en los últimos 30 días.

5. Pacientes que hayan recibido inmunoterapia o terapia antiangiogénica previa para el cáncer colorrectal.

6. Enfermedad inflamatoria intestinal activa o antecedentes de la misma (p. ej., enfermedad de Crohn, colitis ulcerosa o diarrea crónica).

7. Enfermedad resecable.

Información del Ensayo

NCT07228832
Reclutando
Fase 3
600 participantes
Nov 2025
May 2028

Ubicaciones213

Belgium (4)
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Brussels, 1000 Reclutando
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Ghent, 9000 Reclutando
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Haine-Saint-Paul, 7100 Reclutando
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Kortrijk, 8500 Reclutando
Canada (3)
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Toronto, Ontario, M4N 3M5 Reclutando
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Montreal, Quebec, H4A 3J1 Reclutando
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Regina, Saskatchewan, S4T7T1 Reclutando
China (28)
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Beijing, Beijing Municipality, 100020 Reclutando
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Fuzhou, Fujian, 350014 Reclutando
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Guangzhou, Fujian, 350004 Reclutando
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Foshan, Guangdong, 528000 Reclutando
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Guangzhou, Guangdong, 510630 Reclutando
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Shenzhen, Guangdong, 518101 Reclutando
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Haikou, Hainan, 570145 Reclutando
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Shijiazhuang, Hebei, 50011 Reclutando
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Harbin, Heilongjiang, 150081 Reclutando
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Fuzhou, Henan, 455000 Reclutando
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Zhengzhou, Henan, 450052 Reclutando
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Wuhan, Hubei, 430022 Reclutando
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Changsha, Hunan, 410013 Reclutando
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Yueyang, Hunan, 414020 Reclutando
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Chifeng, Inner Mongolia, 24000 Reclutando
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Nanjing, Jiangsu, 210009 Reclutando
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Nanchang, Jiangxi, 330006 Reclutando
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Ch’ang-ch’un, Jilin, 130012 Reclutando
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Shenyang, Liaoning, 110001 Reclutando
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Jinan, Shandong, 250021 Reclutando
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Shanghai, Shanghai Municipality, 200032 Reclutando
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Chengdu, Sichuan, 610041 Reclutando
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Luzhou, Sichuan, 646000 Reclutando
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Kunming, Yunnan, 650118 Reclutando
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Hangzhou, Zhejiang, 310009 Reclutando
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Hangzhou, Zhejiang, 310022 Reclutando
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Ningbo, Zhejiang, 315040 Reclutando
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Wenzhou, Zhejiang, 325000 Reclutando
Czechia (4)
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Hradec Králové, 50005 Reclutando
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Olomouc, 779 00 Reclutando
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Prague, 128 00 Reclutando
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Prague, 14059 Reclutando
France (11)
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Bordeaux, 33076 Reclutando
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Lille, 59000 Reclutando
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Lyon, 69374 Reclutando
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Montpellier, 34298 Reclutando
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Nantes, 44000 Reclutando
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Nice, 06189 Reclutando
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Paris, 75015 Reclutando
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Paris, 75020 Reclutando
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Pierre-Bénite, 69495 Reclutando
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Poitiers, 86000 Reclutando
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Strasbourg, 67033 Reclutando
Germany (4)
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Berlin, 13353 Reclutando
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Bonn, 53113 Reclutando
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Hamburg, 20249 Reclutando
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Hamburg, 22763 Reclutando
Hungary (3)
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Budapest, 1122 Reclutando
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Debrecen, 4032 Reclutando
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Kecskemét, H-6000 Reclutando
Italy (6)
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Brescia, 25124 Reclutando
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Florence, 50134 Reclutando
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Genova, 16132 Reclutando
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Meldola, 47014 Reclutando
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Pisa, 56126 Reclutando
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Verona, 37134 Reclutando
Japan (18)
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Aichi, 464-8681 Reclutando
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Chiba, 260-8717 Reclutando
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Ehime, 791-0280 Reclutando
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Fukuoka, 812-8582 Reclutando
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Gifu, 501-1194 Reclutando
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Hiroshima, 734-8551 Reclutando
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Hokkaido, 060-8648 Reclutando
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Kawasaki, 216-8511 Reclutando
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Osaka, 541-8567 Reclutando
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Saitama, 362-0806 Reclutando
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Sendai, 980-0872 Reclutando
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Shizuoka, 411-8777 Reclutando
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Tokyo, 104-0045 Reclutando
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Tokyo, 113-8677 Reclutando
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Tokyo, 135-8550 Reclutando
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Toyama, 930-0194 Reclutando
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Yokohama, 241-8515 Reclutando
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Osaka, Ontario, 565-0871 Reclutando
Poland (6)
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Gdansk, 80-219 Reclutando
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Olsztyn, 10-228 Reclutando
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Otwock, 05-400 Reclutando
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Warsaw, 02-781 Reclutando
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Warsaw, 04-141 Reclutando
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Rzeszów, Podkarpackie Voivodeship, 35-021 Reclutando
Puerto Rico (1)
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Rio Piedras, 00935 Reclutando
Spain (17)
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A Coruña, 15006 Reclutando
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Barcelona, 08035 Reclutando
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Barcelona, 08036 Reclutando
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Barcelona, 08908 Reclutando
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Barcelona, 08916 Reclutando
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Granada, 18014 Reclutando
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Madrid, 28009 Reclutando
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Madrid, 28046 Reclutando
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Madrid, 28050 Reclutando
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Madrid, 28222 Reclutando
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Málaga, 29010 Reclutando
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Palma de Mallorca, 07198 Reclutando
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Santander, 39008 Reclutando
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Seville, 41013 Reclutando
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Valencia, 46010 Reclutando
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Valencia, 46014 Reclutando
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Valencia, 46026 Reclutando
United Kingdom (6)
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Edinburgh, EH4 2XU Reclutando
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Liverpool, L7 8YA Reclutando
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Manchester, M20 4BX Reclutando
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Canterbury, England, CT13NS Reclutando
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London, England, EC1M 6BQ Reclutando
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Aberdeen, Scotland, AB25 2ZN Reclutando
United States (102)
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Mobile, Alabama, 36604 Reclutando
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Tuscaloosa, Alabama, 35487 Reclutando
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Goodyear, Arizona, 85338 Reclutando
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Beverly Hills, California, 90211 Reclutando
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Beverly Hills, California, 90212 Reclutando
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Cerritos, California, 90703 Reclutando
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Corona, California, 92882 Reclutando
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Duarte, California, 91010 Reclutando
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Fountain Valley, California, 92708 Reclutando
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Huntington Beach, California, 92648 Reclutando
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Irvine, California, 92612 Reclutando
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Irvine, California, 92618 Reclutando
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Los Angeles, California, 90027 Reclutando
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Los Angeles, California, 90067 Reclutando
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Los Angeles, California, 90404 Reclutando
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Murrieta, California, 92562 Reclutando
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Oakland, California, 94611 Reclutando
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Orange, California, 92868 Reclutando
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Pasadena, California, 91030 Reclutando
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Roseville, California, 95661 Reclutando
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San Francisco, California, 94115 Reclutando
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Santa Clara, California, 94115 Reclutando
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Stanford, California, 94305 Reclutando
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Torrance, California, 90503 Reclutando
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Upland, California, 91786 Reclutando
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Vallejo, California, 94589 Reclutando
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West Hollywood, California, 90048 Reclutando
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Hartford, Connecticut, 06106 Reclutando
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New Haven, Connecticut, 06520-8028 Reclutando
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Norwich, Connecticut, 06360 Reclutando
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Newark, Delaware, 19713 Reclutando
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Hialeah, Florida, 33013 Reclutando
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Miami, Florida, 33176 Reclutando
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Miami Beach, Florida, 33140 Reclutando
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Ocala, Florida, 34474 Reclutando
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Orlando, Florida, 32804 Reclutando
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Orlando, Florida, 32806 Reclutando
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Plantation, Florida, 33322 Reclutando
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Port Saint Lucie, Florida, 34952 Reclutando
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St. Petersburg, Florida, 33705 Reclutando
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Tamarac, Florida, 33321 Reclutando
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Atlanta, Georgia, 30303 Reclutando
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Atlanta, Georgia, 30322 Reclutando
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Newnan, Georgia, 30265 Reclutando
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Chicago, Illinois, 60611 Reclutando
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Elmhurst, Illinois, 60540 Reclutando
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O'Fallon, Illinois, 62269 Reclutando
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Fort Wayne, Indiana, 46804 Reclutando
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Indianapolis, Indiana, 46202 Reclutando
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Westwood, Kansas, 66205 Reclutando
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Edgewood, Kentucky, 41017 Reclutando
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New Orleans, Louisiana, 70121 Reclutando
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Baltimore, Maryland, 21201 Reclutando
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Detroit, Michigan, 48201 Reclutando
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Saint Louis Park, Minnesota, 55426 Reclutando
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Springfield, Missouri, 65804 Reclutando
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Billings, Montana, 59102 Reclutando
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Lincoln, Nebraska, 68506 Reclutando
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Lebanon, New Hampshire, 03766 Reclutando
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New Brunswick, New Jersey, 08901 Reclutando
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Mineola, New York, 11501 Reclutando
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New York, New York, 10016 Reclutando
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Rochester, New York, 14642 Reclutando
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Syracuse, New York, 13210 Reclutando
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The Bronx, New York, 10461 Reclutando
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White Plains, New York, 10601-5000 Reclutando
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Pinehurst, North Carolina, 28374 Reclutando
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Akron, Ohio, 44032 Reclutando
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Canton, Ohio, 44703 Reclutando
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Cincinnati, Ohio, 45219 Reclutando
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Cincinnati, Ohio, 45220 Reclutando
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Cleveland, Ohio, 44111 Reclutando
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Cleveland, Ohio, 44195 Reclutando
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Mayfield Heights, Ohio, 44124 Reclutando
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Oklahoma City, Oklahoma, 73120 Reclutando
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Lebanon, Pennsylvania, 17042 Reclutando
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Philadelphia, Pennsylvania, 19107 Reclutando
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Philadelphia, Pennsylvania, 19111 Reclutando
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Philadelphia, Pennsylvania, 19140 Reclutando
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Pittsburgh, Pennsylvania, 15212 Reclutando
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Pittsburgh, Pennsylvania, 15232 Reclutando
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Sellersville, Pennsylvania, 18960 Reclutando
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Providence, Rhode Island, 02903 Reclutando
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Greenville, South Carolina, 29605 Reclutando
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Spartanburg, South Carolina, 29303 Reclutando
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Germantown, Tennessee, 38138 Reclutando
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Hermitage, Tennessee, 37129 Reclutando
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Dallas, Texas, 75235 Reclutando
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Dallas, Texas, 75390 Reclutando
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Fort Worth, Texas, 76104 Reclutando
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Houston, Texas, 77026 Reclutando
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Houston, Texas, 77030 Reclutando
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Tyler, Texas, 75701 Reclutando
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Salt Lake City, Utah, 84106 Reclutando
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Salt Lake City, Utah, 84112 Reclutando
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Burlington, Vermont, 05401 Reclutando
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Charlottesville, Virginia, 22908 Reclutando
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Fairfax, Virginia, 22031 Reclutando
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Spokane, Washington, 99208 Reclutando
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Tacoma, Washington, 98405 Reclutando
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Charleston, West Virginia, 25304 Reclutando
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Madison, Wisconsin, 53792 Reclutando

Fuente Oficial

Ver en ClinicalTrials.gov