Trial Condition(s):

Carcinoma, Hepatocellular

Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular carcinoma (SEARCH)

Bayer Identifier:

12917

ClinicalTrials.gov Identifier:

NCT00901901

EudraCT Number:

2008-006021-14

Study Completed

Trial Purpose

This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

Inclusion Criteria
- Patients > 18 years of age
 - Patients who have a life expectancy of at least 12 weeks
 - Patients with histological or cytologically documented HCC
 - Patients must have at least one tumor lesion that meets both of the following criteria:
 -- The lesion can be accurately measured in at least one dimension according to response evaluation criteria in solid tumors (RECIST)  
 -- The lesion has not been previously treated with local therapy
 - Patients who have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1  
 - Cirrhotic status of Child-Pugh class A.
 - Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time.
Exclusion Criteria
- History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
 - Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sogren’s syndrome) including congenital abnormality (e.g. Fuch’s dystrophy), abnormal slit-lamp examination using a vital dye (e.g. fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test).
 - History of interstitial lung disease (ILD).
 - Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
 - Previous treatment with yttrium-90 spheres
 - Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
 - Uncontrolled ascites (defined as not easily controlled with diuretic treatment)

Trial Summary

Enrollment Goal
732
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Freiburg, Germany, 79106

Status
Completed
 
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München, Germany, 81675

Status
Completed
 
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Hannover, Germany, 30625

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Completed
 
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Homburg, Germany, 66421

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Completed
 
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Regensburg, Germany, 93042

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Completed
 
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Newcastle Upon Tyne, United Kingdom, NE7 7DN

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Completed
 
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San Francisco, United States, 94115

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Completed
 
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Miami, United States, 33136

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Completed
 
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Honolulu, United States, 96817

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Completed
 
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Boston, United States, 02215-5450

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Completed
 
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Westwood, United States, 66205

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Completed
 
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Mainz, Germany, 55131

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Completed
 
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Tübingen, Germany, 72076

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Completed
 
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Berlin, Germany, 12200

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Completed
 
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Frankfurt, Germany, 60590

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Completed
 
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Essen, Germany, 45147

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Köln, Germany, 50937

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London, United Kingdom, SE5 9RS

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Sheffield, United Kingdom, S10 2SJ

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Completed
 
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Glasgow, United Kingdom, G12 0YN

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Completed
 
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New York, United States, 10029

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Completed
 
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Baltimore, United States, 21202

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Philadelpahia, United States, 19107

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Atlanta, United States, 30318

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Detroit, United States, 48202

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New Orleans, United States, 70112

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Louisville, United States, 40202

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PARIS, France, 75012

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Completed
 
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VILLEJUIF, France, 94800

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Completed
 
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BORDEAUX, France, 33000

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Completed
 
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LA ROCHE SUR YON, France, 85925

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Completed
 
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Gliwice, Poland, 44-101

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Completed
 
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Milano, Italy, 20089

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Completed
 
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Valencia, Spain, 46026

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Completed
 
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Seattle, United States, 98109-1023

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Completed
 
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Gainesville, United States, 32610

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Completed
 
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Boston, United States, 02114

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Completed
 
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Washington, United States, 20007

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Completed
 
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Rochester, United States, 14642

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Minneapolis, United States, 55455

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Completed
 
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Worcester, United States, 01655

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Charlotte, United States, 28203

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Completed
 
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Houston, United States, 77030

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Completed
 
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Valhalla, United States, 10595

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Completed
 
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Hospitalet de Llobregat, Spain, 08907

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Completed
 
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Lugo, Spain, 27003

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Valencia, Spain, 46010

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Completed
 
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LEUVEN, Belgium, 3000

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Completed
 
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EDEGEM, Belgium, 2650

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Completed
 
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LIEGE, Belgium, 4000

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Completed
 
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KORTRIJK, Belgium, 8500

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Completed
 
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Cape Town, South Africa, 7500

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Completed
 
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Petah Tikva, Israel, 4941492

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Completed
 
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Melbourne, Australia, 3004

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Completed
 
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Randwick, Australia, 2031

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Completed
 
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Herston, Australia, 4029

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Completed
 
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Maywood, United States, 60153-5585

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Completed
 
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LYON, France, 69004

Status
Completed
 
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CRETEIL, France, 94010

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Completed
 
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MARSEILLE, France, 13005

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Completed
 
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LILLE, France, 59037

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Completed
 
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CLICHY, France, 92110

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Completed
 
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VANDOEUVRE-LES-NANCY, France, 54511

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Completed
 
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Pessac, France, 33604

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Completed
 
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Gdansk, Poland, 80-952

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Completed
 
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Bydgoszcz, Poland, 85-796

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Completed
 
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Warszawa, Poland, 02-781

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Completed
 
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Madrid, Spain, 28040

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Completed
 
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Barcelona, Spain, 08036

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Completed
 
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Brisbane, Australia, 4120

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Completed
 
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Wien, Austria, 1090

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Completed
 
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Santiago, Chile, 7601003

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Completed
 
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Floridablanca, Colombia

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Completed
 
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Larissa, Greece, 41100

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Completed
 
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São Paulo, Brazil, 05651-900

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Completed
 
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Belo Horizonte, Brazil, 30110-090

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Completed
 
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Rio de Janeiro, Brazil, 21941-913

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Completed
 
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Santander, Spain, 39008

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Completed
 
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Montreal, Canada, H3A 1A1

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Completed
 
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Edmonton, Canada, T6G 1Z2

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Completed
 
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BRUXELLES - BRUSSEL, Belgium, 1200

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Completed
 
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GENT, Belgium, 9000

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Completed
 
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LA LOUVIERE, Belgium, 7100

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Completed
 
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Johannesburg, South Africa, 2193

Status
Completed
 
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Zrifin, Israel, 70300

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Completed
 
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Haifa, Israel, 3109601

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Completed
 
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Rehovot, Israel, 7610001

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Completed
 
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Beer Sheva, Israel, 8410101

Status
Completed
 
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Clayton, Australia, 3168

Status
Completed
 
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Sao Paulo, Brazil, 01509-900

Status
Completed
 
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Nizhny Novgorod, Russia, 603001

Status
Completed
 
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Beijing, China, 100021

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Completed
 
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Beijing, China, 100071

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Completed
 
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Hangzhou, China, 310016

Status
Completed
 
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Seoul, South Korea, 05505

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Completed
 
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Taipei, Taiwan, China, 112

Status
Completed
 
Locations

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Taoyuan, Taiwan, China, 333

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Completed
 
Locations

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Tainan, Taiwan, China, 736

Status
Completed
 
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Lima, Peru, LIMA 1

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Completed
 
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Hong Kong, Hong Kong, China

Status
Completed
 
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Singapore, Singapore, 169610

Status
Completed
 
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Nedlands, Australia, 6009

Status
Completed
 
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Sofia, Bulgaria, 1784

Status
Completed
 
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Plovdiv, Bulgaria, 4002

Status
Completed
 
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Varna, Bulgaria, 9002

Status
Completed
 
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Varna, Bulgaria, 9010

Status
Completed
 
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Santiago, Chile, 838-0455

Status
Completed
 
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Investigative Site

Medellín, Colombia

Status
Completed
 
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Investigative Site

Athens, Greece, 115 27

Status
Completed
 
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Investigative Site

Thessaloniki, Greece, 54642

Status
Completed
 
Locations

Investigative Site

Thessaloniki, Greece, 546 36

Status
Completed
 
Locations

Investigative Site

Sao Paulo, Brazil, 05403-000

Status
Completed
 
Locations

Investigative Site

Porto Alegre, Brazil, 90020-090

Status
Completed
 
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Investigative Site

Moscow, Russia, 115478

Status
Completed
 
Locations

Investigative Site

Barnaul, Russia, 656049

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510060

Status
Completed
 
Locations

Investigative Site

Nanjing, China, 210002

Status
Completed
 
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Investigative Site

Seoul, South Korea, 03080

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 06351

Status
Completed
 
Locations

Investigative Site

Goyang-si, South Korea, 410-769

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 152-703

Status
Completed
 
Locations

Investigative Site

Lima, Peru, LIMA 34

Status
Completed
 
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Investigative Site

Shatin, Hong Kong, China

Status
Completed
 
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Investigative Site

Singapore, Singapore, 308433

Status
Completed
 
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Investigative Site

Auckland, New Zealand, 1023

Status
Completed
 
Locations

Investigative Site

Wellington South, New Zealand, 6021

Status
Completed
 
Locations

Investigative Site

Christchurch, New Zealand, 8011

Status
Completed
 

Trial Design