Trial Condition(s):

Carcinoma, Hepatocellular

Study of regorafenib after sorafenib in patients with hepatocellular carcinoma (RESORCE)

Bayer Identifier:

15982

ClinicalTrials.gov Identifier:

NCT01774344

EudraCT Number:

2012-003649-14

Study Completed

Trial Purpose

The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.

Inclusion Criteria
:
 -  Histological or cytological confirmation of HCC (hepatocellular carcinoma) or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases criteria in patients with a confirmed diagnosis of cirrhosis
 - Barcelona Clinic Liver Cancer stage Category B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, local ablation, chemoembolization or systemic sorafenib.
 - Failure to prior treatment with sorafenib (defined as documented radiological progression according to the radiology charter). Randomization needs to be performed within 10 weeks after the last treatment with sorafenib.
 - Tolerability of prior treatment with sorafenib defined as not less than 20 days at a minimum daily dose of 400 mg QD within the last 28 days prior to withdrawal. 
 - Liver function status Child-Pugh Class A. Child Pugh status should be calculated based on clinical findings and laboratory results during the screening period.
Local or loco-regional therapy of intrahepatic tumor lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed >/=4 weeks before first dose of study medication. Note: patients who received sole intrahepatic intraarterial chemotherapy, without lipiodol or embolizing agents are not eligible.
 - Eastern Cooperative Oncology Group  Performance Status of 0 or 1.
 - Adequate bone marrow, liver and renal function as assessed by the following laboratory tests conducted within 7 days before randomization.
 - Glomerular filtration rate  >/= 30 ml/min/1.73 m^2 according to the Modification of diet in renal disease study equation.
 - At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST (RECIST version 1.1), and modified RECIST for HCC. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion.
 - Life expectancy of at least 3 months.
 - Women of childbearing potential and men must agree to use adequate contraception .
Exclusion Criteria
:
 - Sorafenib treatment within 2 weeks of randomization.
 - Prior systemic treatment for HCC, except sorafenib.
 - Permanent discontinuation of prior sorafenib therapy due to sorafenib related toxicity.
 - Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms suggestive or consistent with CNS disease).
 - Uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
 - Uncontrolled ascites (defined as not easily controlled with diuretic or paracentesis treatment).
 - Ongoing infection > Grade 2 according to NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) v. 4.0. Hepatitis B is allowed if no active replication is present. Hepatitis C is allowed if no antiviral treatment is required.
 - Clinically significant bleeding NCI-CTCAE version 4.0 Grade 3 or higher within 30 days before randomization.
 - Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication.
 - Patients unable to swallow oral medications.
 - Interstitial lung disease with ongoing signs and symptoms at the time of screening.

Trial Summary

Enrollment Goal
573
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Mainz, Germany, 55131

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Completed
 
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Magdeburg, Germany, 39120

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Completed
 
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Essen, Germany, 45136

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Completed
 
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Hamburg, Germany, 20246

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Richmond, United States, 23249

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New York, United States, 10029

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Louisville, United States, 40202

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München, Germany, 81377

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PARIS, France, 75651

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Vandoeuvre les Nancy, France, 54500

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Completed
 
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LILLE, France, 59037

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NICE CEDEX 3, France, 06202

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Oviedo, Spain, 33011

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Milano, Italy, 20089

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Bologna, Italy, 40138

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Novara, Italy, 28100

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Roma, Italy, 00168

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Pisa, Italy, 56126

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Napoli, Italy, 80131

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Modena, Italy, 41124

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Foggia, Italy, 71013

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Bergamo, Italy, 24127

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Padova, Italy, 35128

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Frankfurt, Germany, 60590

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Minneapolis, United States, 55455

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Gainesville, United States, 32610-0286

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St. Louis, United States, 63110

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Rochester, United States, 14642

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CLICHY, France, 92110

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Angers, France, 49100

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CRETEIL, France, 94010

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LYON, France, 69004

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Barcelona, Spain, 08036

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Taipei, Taiwan, China, 10016

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Taipei, Taiwan, China, 11217

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Taoyuan, Taiwan, China, 333423

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Kaohsiung City, Taiwan, China, 83301

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LA LOUVIERE, Belgium, 7100

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BRUXELLES - BRUSSEL, Belgium, 1090

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Busan, South Korea, 49241

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Seoul, South Korea, 06351

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Daegu, South Korea, 700-721

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Seoul, South Korea, 110-744

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Los Angeles, United States, 90095

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Washington, United States, 20007-2197

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RENNES CEDEX, France, 35062

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Salvador, Brazil, 41950-610

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London, United Kingdom, SE5 9RS

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Bristol, United Kingdom, BS2 8ED

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Birmingham, United Kingdom, B15 2WB

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Leeds, United Kingdom, LS9 7TF

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Aurora, United States, 80045

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Heidelberg, Germany, 69120

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Berlin, Germany, 13353

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Barcelona, Spain, 08035

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PARIS, France, 75020

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CAEN, France, F-14033

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VILLEJUIF CEDEX, France, 94805

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Singapore, Singapore, 119228

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Aachen, Germany, 52074

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Cagliari, Italy, 09134

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Milano, Italy, 20122

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Genova, Italy, 16132

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Córdoba, Spain, 14004

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Alicante, Spain, 03010

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Bern, Switzerland, 3010

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Los Angeles, United States, 90048

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Pittsburgh, United States, 15232

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Worcester, United States, 01655

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TOULOUSE, France, 31059

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DIJON, France, 21000

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MONTPELLIER CEDEX, France, 34295

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Osakasayama-shi, Japan, 589-8511

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Kashiwa-shi, Japan, 277-8577

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Chuo-ku, Japan, 104-0045

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Chiba-shi, Japan, 260-8677

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Musashino-shi, Japan, 180-8610

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Osaka-shi, Japan, 541-8567

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Fukuoka-shi, Japan, 810-8563

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Madrid, Spain, 28007

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AMSTERDAM, Netherlands, 1105 AZ

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LEIDEN, Netherlands, 2333 ZA

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Budapest, Hungary, 1097

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Debrecen, Hungary, 4032

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Sao Paulo, Brazil, 05403-000

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Moscow, Russia

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Barnaul, Russia, 656045

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Moscow, Russia, 119991

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MARSEILLE, France, 13005

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Kaposvar, Hungary, 7400

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Orange, United States, 92868-3201

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Chicago, United States, 60637

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Pilar, Argentina, B1629ODT

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Bellinzona, Switzerland, 6500

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Nanjing, China, 210002

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Hradec Kralove, Czech Republic, 500 05

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Olomouc, Czech Republic, 775 20

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Zaragoza, Spain, 50009

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Hannover, Germany, 30625

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Herston, Australia, 4029

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Köln, Germany, 50937

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Madrid, Spain, 28050

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Praha 2, Czech Republic, 128 08

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Camperdown, Australia, 2050

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Torino, Italy, 10126

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Liverpool, Australia, 2170

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Madrid, Spain, 28041

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Clayton, Australia, 3168

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BOX HILL, Australia, 3128

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Shanghai, China, 200032

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Xi'an, China, 710061

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Completed
 
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Dalian, China, 116011

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Completed
 
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shanghai, China, 200001

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Completed
 
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Shanghai, China, 201805

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Completed
 
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Xi'an, China, 710032

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Completed
 
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Beijing, China, 100142

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Completed
 
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Hefei, China, 230022

Status
Suspended
 
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Beijing, China, 100071

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Completed
 
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Tianjin, China, 300060

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Completed
 
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Nanning, China, 530021

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Changsha, China, 410013

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Completed
 
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Harbin, China, 150081

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Xi'an, China, 710038

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Chengdu, China, 610041

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Fuzhou, China, 350025

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Guangzhou, China, 510080

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Chongqing, China, 400038

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Seattle, United States, 98101

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Tampa, United States, 33606

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Guangzhou, China, 510515

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Completed
 
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Beijing, China, 100039

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Wuhan, China, 430030

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Completed
 
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Suzhou, China, 215006

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Completed
 
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Beijing, China, 100069

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Completed
 
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Linz, Austria, 4020

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Completed
 
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Wien, Austria, 1090

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Completed
 
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Graz, Austria, 8036

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Completed
 
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Guangzhou, China, 510060

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Completed
 
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REIMS CEDEX, France, 51092

Status
Completed
 
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Investigative Site

PERPIGNAN, France, 66000

Status
Completed
 
Locations

Investigative Site

LA TRONCHE, France, 38700

Status
Completed
 
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Investigative Site

Iizuka-shi, Japan, 820-8505

Status
Completed
 
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Investigative Site

Yokohama-shi, Japan, 232-0024

Status
Completed
 
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Investigative Site

Kumamoto-shi, Japan, 860-8556

Status
Completed
 
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Investigative Site

Chiyoda-ku, Japan, 101-0062

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Completed
 
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Investigative Site

London, United Kingdom, W12 0HS

Status
Completed
 
Locations

Investigative Site

Utsunomiya-shi, Japan, 321-0974

Status
Completed
 

Trial Design