Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
Start Date
8/1/2025
Completion Date
7/17/2029
Summary
This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum based chemotherapy and anti-PD-1/anti-PD-L1 therapy.
Detailed Description
The target population of interest in this study is participants with B7-H4-selected advanced/metastatic EC who have progressed on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 therapy, either separately or in combination and should have received no more than 2 prior lines of therapy in advanced/metastatic setting. Participants will be randomized in a 1:1 ratio to Puxi-Sam (arm A) or physician's choice of chemotherapy (arm B; doxorubicin or paclitaxel). The total study size will be approximately 700 eligible participants. During the treatment period, participants will receive Puxi-Sam IV Day 1 Q3W (Arm A) or either doxorubicin treatment IV Day 1 Q3W or paclitaxel treatment IV on Days 1, 8, and 15 in 28-day cycle (Arm B). This study aims to see if Puxi-Sam allows participants to live longer without their endometrial cancer getting worse, or simply to live longer, compared to participants receiving standard of care chemotherapy. This study is also looking to see how the treatment and the endometrial cancer affects participants' quality of life.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Puxitatug Samrotecan
Doxorubicin
Paclitaxel
Conditions
Locations
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Tucson, Arizona 85719
United States
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La Jolla, California 92037
United States
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Los Angeles, California 90095
United States
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Orange, California 92868
United States
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Washington D.C., District of Columbia 20016
United States
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Jupiter, Florida 33458
United States
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Miami, Florida 33136
United States
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Miami, Florida 33176
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Miami Beach, Florida 33140
United States
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New Port Richey, Florida 34655
United States
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Orlando, Florida 32806
United States
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Tampa, Florida 33612
United States
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West Palm Beach, Florida 33401
United States
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Honolulu, Hawaii 96826
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Chicago, Illinois 60607
United States
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Peoria, Illinois 61637
United States
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Urbana, Illinois 61801
United States
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Fort Wayne, Indiana 46845
United States
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Indianapolis, Indiana 46260
United States
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Scarborough, Maine 04074
United States
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Baltimore, Maryland 21201
United States
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Baltimore, Maryland 21231
United States
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Silver Spring, Maryland 20910
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Ann Arbor, Michigan 48109
United States
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Ann Arbor, Michigan 48197
United States
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Detroit, Michigan 48201
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Minneapolis, Minnesota 55404
United States
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Camden, New Jersey 08103
United States
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Paramus, New Jersey 07652
United States
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Albuquerque, New Mexico 87109
United States
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Brooklyn, New York 11220
United States
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Stony Brook, New York 11794
United States
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The Bronx, New York 10461
United States
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White Plains, New York 10601
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Greenville, North Carolina 27834
United States
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Pinehurst, North Carolina 28374
United States
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Cincinnati, Ohio 45220
United States
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Cleveland, Ohio 44106
United States
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Cleveland, Ohio 44109
United States
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Columbus, Ohio 43219
United States
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Dayton, Ohio 45459
United States
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Hilliard, Ohio 43026
United States
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Sylvania, Ohio 43560
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Eugene, Oregon 97401
United States
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Portland, Oregon 97239
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Bethlehem, Pennsylvania 18015
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Hershey, Pennsylvania 17033
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Lancaster, Pennsylvania 17601
United States
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Philadelphia, Pennsylvania 19107
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Pittsburgh, Pennsylvania 15213
United States
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Pittsburgh, Pennsylvania 15224
United States
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Willow Grove, Pennsylvania 19090
United States
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York, Pennsylvania 17403
United States
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Sioux Falls, South Dakota 57104
United States
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Sioux Falls, South Dakota 57105
United States
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Knoxville, Tennessee 37920
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Nashville, Tennessee 37232
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Austin, Texas 78758
United States
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Houston, Texas 77030
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Tyler, Texas 75702
United States
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Fairfax, Virginia 22031
United States
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Falls Church, Virginia 22042
United States
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Norfolk, Virginia 23502
United States
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Richmond, Virginia 23298
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Roanoke, Virginia 24016
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Kennewick, Washington 99336
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Seattle, Washington 98104
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Morgantown, West Virginia 26505
United States
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Waukesha, Wisconsin 53188
United States
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Capital Federal, C1417DTB
Argentina
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Ciudad Autonoma Buenos Aires, 1405
Argentina
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Ciudad de Buenos Aires, C1118AAT
Argentina
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Córdoba, 2356
Argentina
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Córdoba, X5004FHP
Argentina
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Cuidad Autónoma de Buenos Aire, C1426ANZ
Argentina
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La Rioja, 5300
Argentina
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Pergamino, B2700CPM
Argentina
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Viedma, R8500ACE
Argentina
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Malvern, 3144
Australia
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Melbourne, 3000
Australia
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Randwick, 2031
Australia
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St Leonards, 2065
Australia
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Subiaco, 6008
Australia
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Westmead, 2145
Australia
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Graz, 8036
Austria
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Innsbruck, 6020
Austria
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Vienna, 1090
Austria
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Brussels, 1070
Belgium
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Brussels, 1200
Belgium
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Charleroi, 6000
Belgium
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Edegem, 2650
Belgium
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Ghent, 9000
Belgium
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Leuven, 3000
Belgium
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Liège, 4000
Belgium
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Liège, 4000
Belgium
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Namur, 5000
Belgium
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Belém, 66073-005
Brazil
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Belo Horizonte, 30360-680
Brazil
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Bento Gonçalves, 95700-084
Brazil
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Blumenau, 89010-340
Brazil
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Curitiba, 80510-130
Brazil
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Curitiba, 80810-050
Brazil
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Florianópolis, 88020-210
Brazil
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Joinville, 89201-260
Brazil
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Natal, 59062-000
Brazil
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Porto Alegre, 90020-090
Brazil
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Porto Alegre, 90470-340
Brazil
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Porto Alegre, 90610-001
Brazil
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Recife, 50040-000
Brazil
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Recife, 50070-480
Brazil
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Recife, 52010-075
Brazil
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Ribeirão Preto, 14026-040
Brazil
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Rio de Janeiro, 22281-100
Brazil
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Rio de Janeiro, 22775-001
Brazil
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Salvador, 41950-640
Brazil
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São Caetano do Sul, 09541-270
Brazil
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São Paulo, 01317-000
Brazil
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São Paulo, 01323-000
Brazil
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São Paulo, 01323-020
Brazil
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São Paulo, 01509-900
Brazil
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Sorocaba, 18030-005
Brazil
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Sorocaba, 18052-210
Brazil
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Taubaté, 12030-200
Brazil
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Teresina, 64049-200
Brazil
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Edmonton, Alberta T6G 1Z2
Canada
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Winnipeg, Manitoba R3A 1R9
Canada
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Hamilton, Ontario L8V 5C2
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Kingston, Ontario K7L 2V7
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Montreal, Quebec H2X 0C1
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Montreal, Quebec H3T 1E2
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Beijing, 100021
China
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Beijing, 100026
China
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Beijing, 100044
China
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Beijing, 100730
China
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Changchun, 130021
China
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Changsha, 410011
China
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Changsha, 410013
China
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Chengdu, 610041
China
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Chongqing, 400030
China
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Dalian, 116023
China
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Fuzhou, 350014
China
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Guangzhou, 510120
China
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Hangzhou, 310006
China
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Hangzhou, 310022
China
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Jinan, 250012
China
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Jinan, 250117
China
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Nanchang, 330006
China
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Nanjing, 210004
China
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Shanghai, 200011
China
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Shanghai, 200025
China
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Shanghai, 200072
China
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Shenyang, 110004
China
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Shenyang, 110042
China
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Shenzhen, 518116
China
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Shijiazhuang, 050011
China
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Tianjin, 300060
China
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Tianjin, 300110
China
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Wenzhou, 325000
China
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Wuhan, 430022
China
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Wuhan, 430030
China
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Xi'an, 710061
China
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Zhanjiang, 524001
China
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Zhengzhou, 450002
China
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Brno, 625 00
Czechia
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Brno, 656 53
Czechia
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Hradec Králové, 500 05
Czechia
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Nový Jičín, 74101
Czechia
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Ostrava, 708 502
Czechia
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Prague, 12808
Czechia
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Prague, 180 81
Czechia
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V Uvalu 84, 150 06
Czechia
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Herlev, 2730
Denmark
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Odense, 5000
Denmark
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Kuopio, 70210
Finland
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Tampere, 33520
Finland
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Turku, 20520
Finland
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Avignon, 84918
France
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Besançon, 25000
France
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Bordeaux, 33076
France
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Chambray-lès-Tours, 37170
France
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Cholet, 49300
France
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Créteil, 94010
France
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Grenoble, 38000
France
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Lille, 59000
France
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Limoges, 87042
France
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Lyon, 69008
France
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Nantes, 44000
France
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Nîmes, 30029
France
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Paris, 75014
France
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Paris, 75020
France
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Paris, 75900
France
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Plerin SUR MER, 22190
France
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Rennes, 35000
France
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Toulouse, 31059
France
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Batumi, 6000
Georgia
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Tbilisi, 0159
Georgia
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Tbilisi, 0186
Georgia
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Amberg, 92224
Germany
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Chemnitz, 09116
Germany
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Dresden, 01307
Germany
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Essen, 45130
Germany
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Frankfurt am Main, 60596
Germany
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Freiburg im Breisgau, 79106
Germany
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Hamburg, 20246
Germany
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Heidelberg, 69120
Germany
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Heilbronn, 74078
Germany
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Kassel, 34125
Germany
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Mainz, 55131
Germany
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Münster, 48149
Germany
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Paderborn, 33161
Germany
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Regensburg, 93053
Germany
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Schwäbisch Hall, 74523
Germany
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Ulm, 89075
Germany
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Witten, 58452
Germany
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Athens, 115 28
Greece
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Athens, 11528
Greece
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Athens, 14564
Greece
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Thessaloniki, 55236
Greece
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Budapest, 1082
Hungary
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Budapest, 1122
Hungary
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Debrecen, 4032
Hungary
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Győr, 9024
Hungary
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Ashdod, 7747629
Israel
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Hadera, 38100
Israel
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Haifa, 3109601
Israel
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Holon, 5822012
Israel
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Jerusalem, 9103102
Israel
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Jerusalem, 9112001
Israel
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Nahariya, 2210001
Israel
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Ramat Gan, 5262000
Israel
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Safed, 13100
Israel
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Tel Aviv, 6423906
Israel
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Alessandria, 15121
Italy
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Aviano, 33081
Italy
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Bari, 70124
Italy
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Bologna, 40138
Italy
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Catania, 95126
Italy
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Florence, 50134
Italy
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Haifa, 34362
Italy
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Milan, 20132
Italy
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Milan, 20141
Italy
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Milan, 20159
Italy
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Milan, 20162
Italy
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Monza, 20900
Italy
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Naples, 80131
Italy
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Padova, 35128
Italy
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Parma, 43126
Italy
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Pisa, 56100
Italy
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Ponderano, 13875
Italy
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Roma, 00168
Italy
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Torino, 10128
Italy
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Vicenza, 36100
Italy
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Chūōku, 104-0045
Japan
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Hidaka-shi, 350-1298
Japan
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Isehara-shi, 259-1193
Japan
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Kashiwa-shi, 277-8567
Japan
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Kōtoku, 135-8550
Japan
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Kurume-shi, 830-0011
Japan
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Matsuyama, 791-0280
Japan
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Minatoku, 105-8471
Japan
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Nagoya, 464-8681
Japan
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Nakagami-gun, 903-0215
Japan
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Niigata, 951-8510
Japan
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Okayama, 700-8558
Japan
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Osaka, 637086
Japan
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Sapporo, 003-0804
Japan
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Sapporo, 060-8638
Japan
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Sendai, 980-8574
Japan
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Suita, 565-0871
Japan
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Sunto-gun, 411-8777
Japan
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Toon-Shi, 791-0295
Japan
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Tsu, 514-8507
Japan
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Yokohama, 236-0004
Japan
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Kaunas, LT50009
Lithuania
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Vilnius, 08661
Lithuania
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Vilnius, 8660
Lithuania
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Amsterdam, 1081 HV
Netherlands
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Maastricht, 6202 AZ
Netherlands
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Lodz, 93-338
Poland
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Siedlce, 08-110
Poland
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Singapore, 119228
Singapore
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Singapore, 168583
Singapore
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Singapore, 217562
Singapore
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Ljubljana, 1000
Slovenia
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Maribor, 2000
Slovenia
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Goyang-si, 410-769
South Korea
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Gwangjin-gu, 110-744
South Korea
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Seoul, 03722
South Korea
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Seoul, 06273
South Korea
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Seoul, 135-710
South Korea
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Songpa-gu, 05505
South Korea
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Suwon, 16499
South Korea
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Badalona, 8916
Spain
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Barcelona, 8025
Spain
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Barcelona, 8035
Spain
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Córdoba, 14004
Spain
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El Palmar (Murcia), 30120
Spain
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L'Hospitalet de Llobregat, 8908
Spain
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Madrid, 28033
Spain
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Madrid, 28041
Spain
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Málaga, 29010
Spain
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Oviedo, 33011
Spain
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Santiago de Compostela, 15706
Spain
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Seville, 41013
Spain
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Seville, 41014
Spain
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Valencia, 46010
Spain
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New Taipei City, 220
Taiwan
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Taichung, 40705
Taiwan
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Tainan, 70403
Taiwan
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Taipei, 100
Taiwan
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Taipei, 10449
Taiwan
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Bebington, CH63 4JY
United Kingdom
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Canterbury, CT1 3NG
United Kingdom
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Derby, DE22 3NE
United Kingdom
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London, E1 1BB
United Kingdom
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London, SE1 7EH
United Kingdom
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London, W2 1NY
United Kingdom
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Manchester, M20 4BX
United Kingdom
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Northwood, HA6 2RN
United Kingdom
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Truro, TR1 3LJ
United Kingdom