Trial Condition(s):

Colorectal Neoplasms

Regorafenib in subjects with metastatic colorectal cancer (CRC) who have progressed after standard therapy (CONSIGN)

Bayer Identifier:

15967

ClinicalTrials.gov Identifier:

NCT01538680

EudraCT Number:

2011-005836-25

EU CT Number:

Not Available

Study Completed

Trial Purpose

This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access.
Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.
The primary endpoint of this study will be safety.

Inclusion Criteria
- Male or female subjects 18 years of age
 - Life expectancy of at least 3 months
 - Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
 - Subjects with metastatic colorectal cancer (Stage IV)
 - Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab (if KRAS WT) (WT: wild type)
 - ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
 - Adequate bone marrow, liver and renal function
 - Women of childbearing potential and men must agree to use adequate contraception
Exclusion Criteria
- Prior treatment with regorafenib
 - Congestive heart failure >/= New York Heart Association (NYHA) class 2
 - Uncontrolled hypertension (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
 - Any hemorrhage or bleeding event >/= CTCAE Grade 3 within 4 weeks prior to the start of study medication.
 - Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours)
 - Unresolved toxicity higher than CTCAE (v. 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity </= Grade 2
 - Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks (or within 6 weeks for mitomycin C) before starting to receive study medication

Trial Summary

Enrollment Goal
N/A
Trial Dates
N/A
black-arrow
N/A
Phase
N/A
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
N/A

Where to Participate

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Halle, Germany, 06120

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Porta Westfalica, Germany, 32457

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Sumter, United States, 29150

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Santa Maria, United States, 93454

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Charleston, United States, 29414

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Cedar Rapids, United States, 52403

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Jefferson City, United States, 65109

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Ann Arbor, United States, 48106

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Aventura, United States, 33180

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Los Angeles, United States, 90033

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Dallas, United States, 75390-9110

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New Orleans, United States, 70121

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Barcelona, Spain, 08035

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Sevilla, Spain, 41013

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Sabadell, Spain, 08208

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Madrid, Spain, 28041

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Málaga, Spain, 29010

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Madrid, Spain, 28040

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Madrid, Spain, 28046

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Hospitalet de Llobregat, Spain, 08907

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Madrid, Spain, 28034

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Montreal, Canada, H2W 1S6

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Mississauga, Canada, L5M 2N1

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Oshawa, Canada, L1G 2B9

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Toronto, Canada, M4N 3M5

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Praha, Czech Republic, 18081

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Brno, Czech Republic, 65 653

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Haifa, Israel, 3109601

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Tel Aviv, Israel, 6423906

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Petah Tikva, Israel, 4941492

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Jerusalem, Israel, 9112001

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Beer Sheva, Israel, 8410101

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Manchester, United Kingdom, M20 4BX

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Leicester, United Kingdom, LE1 5WW

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AMSTERDAM, Netherlands, 1081 HV

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LEIDEN, Netherlands, 2333 ZA

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Concord, Australia, 2139

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Parkville, Australia, 3050

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Footscray, Australia, 3011

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Woodville South, Australia, 5011

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St Leonards, Australia, 2065

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Genova, Italy, 16132

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Napoli, Italy, 80131

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Modena, Italy, 41124

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Pisa, Italy, 56126

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Milano, Italy, 20162

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Brescia, Italy, 25124

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Roma, Italy, 00168

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Reggio Emilia, Italy, 42123

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Ancona, Italy, 60126

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Santander, Spain, 39008

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LEUVEN, Belgium, 3000

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ROESELARE, Belgium, 8800

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BRUXELLES - BRUSSEL, Belgium, 1000

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BRUXELLES - BRUSSEL, Belgium, 1200

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EDEGEM, Belgium, 2650

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BRUXELLES - BRUSSEL, Belgium, 1070

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Genève, Switzerland, 1205

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München, Germany, 81377

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München, Germany, 81737

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Oldenburg, Germany, 26133

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Magdeburg, Germany, 39104

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München, Germany, 81925

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Essen, Germany, 45122

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Trier, Germany, 54290

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Dresden, Germany, 01307

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Köln, Germany, 50924

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Mannheim, Germany, 68167

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Hannover, Germany, 30625

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Freiburg, Germany, 79106

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Herne, Germany, 44625

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Recklinghausen, Germany, 45659

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Lake Success, United States, 11042

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Avignon, France, 84000

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PARIS, France, 75571

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PARIS, France, 75651

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LILLE CEDEX, France, 59020

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LILLE CEDEX, France, 59037

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LE MANS CEDEX 2, France, 72015

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REIMS CEDEX, France, 51092

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MARSEILLE, France, 13005

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MONTPELLIER CEDEX, France, 34298

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Strasbourg Cedex, France, 67085

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New Haven, United States, 06520

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New York, United States, 10016

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Denver, United States, 80218

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La Jolla, United States, 92037

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Detroit, United States, 48201

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Portsmouth, United States, 23704

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New York, United States, 10021

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Park Ridge, United States, 60068

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Seattle, United States, 98104

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Philadelphia, United States, 19111-2497

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New York, United States, 10003

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Duarte, United States, 91010

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Detroit, United States, 48202

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Jackson, United States, 39202

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Brewer, United States, 04412

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Richmond, United States, 23298-0037

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Columbus, United States, 31904

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Portland, United States, 97239

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Atlanta, United States, 30318

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Omaha, United States, 68106

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Miami Beach, United States, 33140

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Cincinnati, United States, 45219

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Bronx, United States, 10461

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Providence, United States, 02908

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Nashville, United States, 37232

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Cleveland, United States, 44195

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Shreveport, United States, 71130

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Ocala, United States, 34474

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Memphis, United States, 38120

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Innsbruck, Austria, 6020

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Graz, Austria, 8036

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Wien, Austria, 1090

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Poznan, Poland, 60-569

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Bialystok, Poland, 15-027

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Long Beach, United States, 90813

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Savannah, United States, 31405

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Las Vegas, United States, 89169

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Sioux City, United States, 51101

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Lebanon, United States, 03756

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Dublin, Ireland, 24

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Cork, Ireland

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AMSTERDAM, Netherlands, 1105 AZ

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Oslo, Norway, 0450

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Budapest, Hungary, 1097

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Zürich, Switzerland, 8091

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Chur, Switzerland, 7000

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Helsinki, Finland, 00180

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Leverkusen, Germany, 51375

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Bochum, Germany, 44892

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SAINT HERBLAIN, France, 44805

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Bordeaux, France

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Nice, France, 06102

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CLERMONT-FERRAND Cedex 1, France, 63003

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Toulouse, France, 31059

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Porto, Portugal, 4200- 319

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Coimbra, Portugal, 3030-075

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Palermo, Italy, 90127

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Foggia, Italy, 71013

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Firenze, Italy, 50134

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Milano, Italy, 20089

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Padova, Italy, 35128

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Milano, Italy, 20133

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Wels, Austria, 4600

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Obninsk, Russia, 249036

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St. Petersburg, Russia, 197022

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Edmonton, Canada, T6G 1Z2

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Barcelona, Spain, 08036

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A Coruña, Spain, 15006

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Badalona (Barcelona), Spain, 08916

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Madrid, Spain, 28007

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Mönchengladbach, Germany, 41063

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Hamburg, Germany, 20246

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Esslingen, Germany, 73730

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Berlin, Germany, 12200

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Valencia, Spain, 46014

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Córdoba, Spain, 14004

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Uppsala, Sweden, 751 85

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Bern, Switzerland, 3010

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Heraklion, Greece, 711 10

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Kifissia / Athens, Greece, 14564

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Ulm, Germany, 89081

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Basel, Switzerland, 4031

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PARIS CEDEX 15, France, 75908

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Helsinki, Finland, 00290

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Aarhus C, Denmark, 8000

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Copenhagen, Denmark, 2100

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Calgary, Canada, T2N 4N2

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Veracruz, Mexico, 91910

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Oaxaca, Mexico, 68000

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Mexico, D.F., Mexico, 01120

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Mexico, D.F., Mexico, 14050

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México, D.F., Mexico, 14080

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Aguascalientes, Mexico, 20230

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Quebec, Canada, G1R 2J6

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Toluca, Mexico, 50180

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Irapuato, Mexico, 36500

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México, Mexico, 14080

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Krasnodar, Russia, 350040

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Orenburg, Russia, 460021

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Kazan, Russia, 420029

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Moscow, Russia, 119991

For details, please refer to trial results

Additional Information