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

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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Locations
Status
LocationsStatus
Locations

Investigative Site

Halle, Germany, 06120

Status
Completed
 
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Porta Westfalica, Germany, 32457

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Completed
 
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Sumter, United States, 29150

Status
Completed
 
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Santa Maria, United States, 93454

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Completed
 
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Charleston, United States, 29414

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Completed
 
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Cedar Rapids, United States, 52403

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Completed
 
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Jefferson City, United States, 65109

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Completed
 
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Ann Arbor, United States, 48106

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Completed
 
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Aventura, United States, 33180

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Completed
 
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Los Angeles, United States, 90033

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Completed
 
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Dallas, United States, 75390-9110

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Completed
 
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New Orleans, United States, 70121

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Completed
 
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Barcelona, Spain, 08035

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Completed
 
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Sevilla, Spain, 41013

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Completed
 
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Sabadell, Spain, 08208

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Completed
 
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Madrid, Spain, 28041

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Completed
 
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Málaga, Spain, 29010

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Completed
 
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Madrid, Spain, 28040

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Completed
 
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Madrid, Spain, 28046

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Completed
 
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Hospitalet de Llobregat, Spain, 08907

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Completed
 
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Madrid, Spain, 28034

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Completed
 
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Montreal, Canada, H2W 1S6

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Completed
 
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Mississauga, Canada, L5M 2N1

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Completed
 
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Oshawa, Canada, L1G 2B9

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Completed
 
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Toronto, Canada, M4N 3M5

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Completed
 
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Praha, Czech Republic, 18081

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Completed
 
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Brno, Czech Republic, 65 653

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Completed
 
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Haifa, Israel, 3109601

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Completed
 
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Tel Aviv, Israel, 6423906

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Completed
 
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Petah Tikva, Israel, 4941492

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Completed
 
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Jerusalem, Israel, 9112001

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Completed
 
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Beer Sheva, Israel, 8410101

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Completed
 
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Manchester, United Kingdom, M20 4BX

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Completed
 
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Leicester, United Kingdom, LE1 5WW

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Completed
 
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AMSTERDAM, Netherlands, 1081 HV

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Completed
 
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LEIDEN, Netherlands, 2333 ZA

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Completed
 
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Concord, Australia, 2139

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Completed
 
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Parkville, Australia, 3050

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Completed
 
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Footscray, Australia, 3011

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Completed
 
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Woodville South, Australia, 5011

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Completed
 
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St Leonards, Australia, 2065

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Completed
 
Locations

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Genova, Italy, 16132

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Completed
 
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Napoli, Italy, 80131

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Completed
 
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Modena, Italy, 41124

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Completed
 
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Pisa, Italy, 56126

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Completed
 
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Milano, Italy, 20162

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Completed
 
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Brescia, Italy, 25124

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Completed
 
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Roma, Italy, 00168

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Completed
 
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Reggio Emilia, Italy, 42123

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Completed
 
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Ancona, Italy, 60126

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Completed
 
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Santander, Spain, 39008

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Completed
 
Locations

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LEUVEN, Belgium, 3000

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Completed
 
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ROESELARE, Belgium, 8800

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Completed
 
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BRUXELLES - BRUSSEL, Belgium, 1000

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Completed
 
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BRUXELLES - BRUSSEL, Belgium, 1200

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Completed
 
Locations

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EDEGEM, Belgium, 2650

Status
Completed
 
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BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

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Genève, Switzerland, 1205

Status
Completed
 
Locations

Investigative Site

München, Germany, 81377

Status
Completed
 
Locations

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München, Germany, 81737

Status
Completed
 
Locations

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Oldenburg, Germany, 26133

Status
Completed
 
Locations

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Magdeburg, Germany, 39104

Status
Completed
 
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München, Germany, 81925

Status
Completed
 
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Essen, Germany, 45122

Status
Completed
 
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Trier, Germany, 54290

Status
Completed
 
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Dresden, Germany, 01307

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Completed
 
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Köln, Germany, 50924

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Completed
 
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Mannheim, Germany, 68167

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Completed
 
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Hannover, Germany, 30625

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Completed
 
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Freiburg, Germany, 79106

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Completed
 
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Herne, Germany, 44625

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Completed
 
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Recklinghausen, Germany, 45659

Status
Completed
 
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Lake Success, United States, 11042

Status
Completed
 
Locations

Investigative Site

Avignon, France, 84000

Status
Completed
 
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Investigative Site

PARIS, France, 75571

Status
Completed
 
Locations

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PARIS, France, 75651

Status
Completed
 
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LILLE CEDEX, France, 59020

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Completed
 
Locations

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LILLE CEDEX, France, 59037

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Completed
 
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LE MANS CEDEX 2, France, 72015

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Completed
 
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REIMS CEDEX, France, 51092

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Completed
 
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MARSEILLE, France, 13005

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Completed
 
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MONTPELLIER CEDEX, France, 34298

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Completed
 
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Strasbourg Cedex, France, 67085

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Completed
 
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New Haven, United States, 06520

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Completed
 
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New York, United States, 10016

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Completed
 
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Denver, United States, 80218

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Completed
 
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La Jolla, United States, 92037

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Completed
 
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Detroit, United States, 48201

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Completed
 
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Portsmouth, United States, 23704

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Completed
 
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New York, United States, 10021

Status
Completed
 
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Park Ridge, United States, 60068

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Completed
 
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Seattle, United States, 98104

Status
Completed
 
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Philadelphia, United States, 19111-2497

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Completed
 
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Investigative Site

New York, United States, 10003

Status
Completed
 
Locations

Investigative Site

Duarte, United States, 91010

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Completed
 
Locations

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Detroit, United States, 48202

Status
Completed
 
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Investigative Site

Jackson, United States, 39202

Status
Completed
 
Locations

Investigative Site

Brewer, United States, 04412

Status
Completed
 
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Investigative Site

Richmond, United States, 23298-0037

Status
Completed
 
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Investigative Site

Columbus, United States, 31904

Status
Completed
 
Locations

Investigative Site

Portland, United States, 97239

Status
Completed
 
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Investigative Site

Atlanta, United States, 30318

Status
Completed
 
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Investigative Site

Omaha, United States, 68106

Status
Completed
 
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Investigative Site

Miami Beach, United States, 33140

Status
Completed
 
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Investigative Site

Cincinnati, United States, 45219

Status
Completed
 
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Investigative Site

Bronx, United States, 10461

Status
Completed
 
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Investigative Site

Providence, United States, 02908

Status
Completed
 
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Investigative Site

Nashville, United States, 37232

Status
Completed
 
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Investigative Site

Cleveland, United States, 44195

Status
Completed
 
Locations

Investigative Site

Shreveport, United States, 71130

Status
Completed
 
Locations

Investigative Site

Ocala, United States, 34474

Status
Completed
 
Locations

Investigative Site

Memphis, United States, 38120

Status
Completed
 
Locations

Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Poznan, Poland, 60-569

Status
Completed
 
Locations

Investigative Site

Bialystok, Poland, 15-027

Status
Completed
 
Locations

Investigative Site

Long Beach, United States, 90813

Status
Completed
 
Locations

Investigative Site

Savannah, United States, 31405

Status
Completed
 
Locations

Investigative Site

Las Vegas, United States, 89169

Status
Completed
 
Locations

Investigative Site

Sioux City, United States, 51101

Status
Completed
 
Locations

Investigative Site

Lebanon, United States, 03756

Status
Completed
 
Locations

Investigative Site

Dublin, Ireland, 24

Status
Completed
 
Locations

Investigative Site

Cork, Ireland

Status
Completed
 
Locations

Investigative Site

AMSTERDAM, Netherlands, 1105 AZ

Status
Completed
 
Locations

Investigative Site

Oslo, Norway, 0450

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1097

Status
Completed
 
Locations

Investigative Site

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Investigative Site

Chur, Switzerland, 7000

Status
Completed
 
Locations

Investigative Site

Helsinki, Finland, 00180

Status
Completed
 
Locations

Investigative Site

Leverkusen, Germany, 51375

Status
Completed
 
Locations

Investigative Site

Bochum, Germany, 44892

Status
Completed
 
Locations

Investigative Site

SAINT HERBLAIN, France, 44805

Status
Completed
 
Locations

Investigative Site

Bordeaux, France

Status
Completed
 
Locations

Investigative Site

Nice, France, 06102

Status
Completed
 
Locations

Investigative Site

CLERMONT-FERRAND Cedex 1, France, 63003

Status
Completed
 
Locations

Investigative Site

Toulouse, France, 31059

Status
Completed
 
Locations

Investigative Site

Porto, Portugal, 4200- 319

Status
Completed
 
Locations

Investigative Site

Coimbra, Portugal, 3030-075

Status
Completed
 
Locations

Investigative Site

Palermo, Italy, 90127

Status
Completed
 
Locations

Investigative Site

Foggia, Italy, 71013

Status
Completed
 
Locations

Investigative Site

Firenze, Italy, 50134

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20089

Status
Completed
 
Locations

Investigative Site

Padova, Italy, 35128

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20133

Status
Completed
 
Locations

Investigative Site

Wels, Austria, 4600

Status
Completed
 
Locations

Investigative Site

Obninsk, Russia, 249036

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 197022

Status
Completed
 
Locations

Investigative Site

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

A Coruña, Spain, 15006

Status
Completed
 
Locations

Investigative Site

Badalona (Barcelona), Spain, 08916

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28007

Status
Completed
 
Locations

Investigative Site

Mönchengladbach, Germany, 41063

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 20246

Status
Completed
 
Locations

Investigative Site

Esslingen, Germany, 73730

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 12200

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46014

Status
Completed
 
Locations

Investigative Site

Córdoba, Spain, 14004

Status
Completed
 
Locations

Investigative Site

Uppsala, Sweden, 751 85

Status
Completed
 
Locations

Investigative Site

Bern, Switzerland, 3010

Status
Completed
 
Locations

Investigative Site

Heraklion, Greece, 711 10

Status
Completed
 
Locations

Investigative Site

Kifissia / Athens, Greece, 14564

Status
Completed
 
Locations

Investigative Site

Ulm, Germany, 89081

Status
Completed
 
Locations

Investigative Site

Basel, Switzerland, 4031

Status
Completed
 
Locations

Investigative Site

PARIS CEDEX 15, France, 75908

Status
Completed
 
Locations

Investigative Site

Helsinki, Finland, 00290

Status
Completed
 
Locations

Investigative Site

Aarhus C, Denmark, 8000

Status
Completed
 
Locations

Investigative Site

Copenhagen, Denmark, 2100

Status
Completed
 
Locations

Investigative Site

Calgary, Canada, T2N 4N2

Status
Completed
 
Locations

Investigative Site

Veracruz, Mexico, 91910

Status
Completed
 
Locations

Investigative Site

Oaxaca, Mexico, 68000

Status
Completed
 
Locations

Investigative Site

Mexico, D.F., Mexico, 01120

Status
Completed
 
Locations

Investigative Site

Mexico, D.F., Mexico, 14050

Status
Completed
 
Locations

Investigative Site

México, D.F., Mexico, 14080

Status
Completed
 
Locations

Investigative Site

Aguascalientes, Mexico, 20230

Status
Completed
 
Locations

Investigative Site

Quebec, Canada, G1R 2J6

Status
Completed
 
Locations

Investigative Site

Toluca, Mexico, 50180

Status
Completed
 
Locations

Investigative Site

Irapuato, Mexico, 36500

Status
Completed
 
Locations

Investigative Site

México, Mexico, 14080

Status
Completed
 
Locations

Investigative Site

Krasnodar, Russia, 350040

Status
Completed
 
Locations

Investigative Site

Orenburg, Russia, 460021

Status
Completed
 
Locations

Investigative Site

Kazan, Russia, 420029

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 119991

Status
Completed
 

For details, please refer to trial results

Additional Information