Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma

Study VEG108844, A Study of Pazopanib Versus Sunitinib in the Treatment of Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma

ClinicalTrials.gov Identifier: NCT00720941

Novartis Reference Number: 108844

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study is being conducted to provide a direct comparison of the efficacy, safety and tolerability for pazopanib and sunitinib (SUTENT)

Condition 
Carcinoma, Renal Cell
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
927 participants
Start date 
Aug 14, 2008
Completion date 
Nov 30, 2020
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Pazopanib
800 mg administered once daily orally continuous dosing
Drug
Sunitinib
50 mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment

Eligibility Criteria

Inclusion Criteria:

Written informed consent
Diagnosis of renal cell carcinoma with clear-cell component histology.
Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC
Locally advanced or metastatic renal cell carcinoma
Measurable disease by CT or MRI
Karnofsky performance scale status of >=70
Age >=18 years
A female is eligible to enter and participate in this study if she is of: non-childbearing or agrees to use adequate contraception.
Adequate organ system function
Total serum calcium concentration <12.0mg/dL
Left ventricular ejection fraction >= lower limit of institutional normal.

Exclusion Criteria:

Pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study)
History of another malignancy (unless have been disease-free for 3 years)
History or clinical evidence of central nervous system (CNS) metastases (unless have previously-treated CNS metastases and meet all 3 of the following criteria are: are asymptomatic, have had no evidence of active CNS metastases for >=6 months prior to enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants)
Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, known intraluminal metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
Presence of uncontrolled infection.
Prolongation of corrected QT interval (QTc) > 480 milliseconds
History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association
History of cerebrovascular accident including transient ischemic attack within the past 12 months
History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless had recent DVT and have been treated with therapeutic anti-coagulating agents for at least 6 weeks)
Poorly controlled hypertension (defined as systolic blood pressure of >=150mmHg or diastolic blood pressure of >=90mmHg). Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry
Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
Evidence of active bleeding or bleeding susceptibility
Spitting/coughing up blood within 6 weeks of first dose of study drug
Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study.
Use any prohibited medications within 14 days of the first dose of study medication.
Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafenib, etc), or are mTOR inhibitors (eg. temsirolimus, everolimus, etc).
Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy)
Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or sunitinib.

Study Locations

United States
Novartis Investigative Site
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Huntsville, 35805
Alabama
United States
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Tucson, 85710
Arizona
United States
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Little Rock, 72205
Arkansas
United States
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Beverly Hills, 90211
California
United States
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Escondido, 92025
California
United States
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Fresno, 93720
California
United States
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Greenbrae, 94904-2007
California
United States
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Hayward, 94545
California
United States
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La Jolla, 92037
California
United States
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Los Angeles, 90095
California
United States
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Montebello, 90640
California
United States
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Oakland, 94611
California
United States
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Orange, 92868
California
United States
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Roseville, 95661
California
United States
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Sacramento, 95817
California
United States
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Sacramento, 95825
California
United States
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San Bernardino, 92404
California
United States
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San Francisco, 94115
California
United States
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San Jose, 95119-1110
California
United States
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Santa Clara, 95051
California
United States
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South San Francisco, 94080
California
United States
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Vallejo, 94589
California
United States
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Walnut Creek, 94596
California
United States
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Denver, 80218
Colorado
United States
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Southington, 06489
Connecticut
United States
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Trumbull, 06611
Connecticut
United States
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Washington, 20007
District of Columbia
United States
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Fort Myers, 33916
Florida
United States
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Miami, 33136
Florida
United States
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Orlando, 32806
Florida
United States
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Atlanta, 30318
Georgia
United States
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Chicago, 60612
Illinois
United States
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Elk Grove Village, 60007
Illinois
United States
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Maywood, 60153
Illinois
United States
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Peoria, 61615-7822
Illinois
United States
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Carmel, 46032
Indiana
United States
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Indianapolis, 46202
Indiana
United States
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Indianapolis, 46237
Indiana
United States
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Cedar Rapids, 52403
Iowa
United States
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Louisville, 40202
Kentucky
United States
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Paducah, 42003
Kentucky
United States
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Annapolis, 21401
Maryland
United States
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Boston, 02114
Massachusetts
United States
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Boston, 02115
Massachusetts
United States
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Boston, 02215
Massachusetts
United States
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Worcester, 01608
Massachusetts
United States
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Detroit, 48201
Michigan
United States
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Duluth, 55805
Minnesota
United States
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Minneapolis, 55455
Minnesota
United States
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Tupelo, 38801
Mississippi
United States
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Kansas City, 64118
Missouri
United States
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Kansas City, 64131
Missouri
United States
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Lincoln, 68510
Nebraska
United States
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Las Vegas, 89135
Nevada
United States
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Las Vegas, 89169
Nevada
United States
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Lebanon, 03756
New Hampshire
United States
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Hackensack, 07601
New Jersey
United States
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Buffalo, 14215
New York
United States
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New York, 10032
New York
United States
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New York, 10065
New York
United States
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Hickory, 28602
North Carolina
United States
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Raleigh, 27607
North Carolina
United States
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Cincinnati, 45242
Ohio
United States
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Cleveland, 44106
Ohio
United States
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Columbus, 43210
Ohio
United States
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Columbus, 43219
Ohio
United States
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Dayton, 45429
Ohio
United States
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Oklahoma City, 73120
Oklahoma
United States
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Tulsa, 74136
Oklahoma
United States
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Eugene, 97401
Oregon
United States
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Portland, 97213
Oregon
United States
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Philadelphia, 19102
Pennsylvania
United States
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Philadelphia, 19111
Pennsylvania
United States
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Charleston, 29403
South Carolina
United States
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Charleston, 29425
South Carolina
United States
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Greenville, 29605
South Carolina
United States
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Mount Pleasant, 29464
South Carolina
United States
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Chattanooga, 37404
Tennessee
United States
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Nashville, 37203
Tennessee
United States
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Arlington, 76012
Texas
United States
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Bedford, 76022
Texas
United States
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Corpus Christi, 78463-3069
Texas
United States
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Dallas, 75246
Texas
United States
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Fort Worth, 76104
Texas
United States
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Lubbock, 79410
Texas
United States
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Round Rock, 78681
Texas
United States
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San Antonio, 78229
Texas
United States
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Tyler, 75702
Texas
United States
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Webster, 77598-4420
Texas
United States
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Wichita Falls, 76310
Texas
United States
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Charlottesville, 22903
Virginia
United States
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Hampton, 23666
Virginia
United States
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Richmond, 23230
Virginia
United States
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Salem, 24153
Virginia
United States
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Seattle, 98101
Washington
United States
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Seattle, 98109
Washington
United States
Australia
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Camperdown, 2050
New South Wales
Australia
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Kogarah, 2217
New South Wales
Australia
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Randwick, 2031
New South Wales
Australia
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Waratah, 2298
New South Wales
Australia
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Westmead, 2145
New South Wales
Australia
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Bedford Park, 5042
South Australia
Australia
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Hobart, 7000
Tasmania
Australia
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Heidelberg, 3084
Victoria
Australia
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Wodonga, 3690
Victoria
Australia
Canada
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Calgary, T2N 4N2
Alberta
Canada
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Edmonton, T6G 1Z2
Alberta
Canada
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Vancouver, V5Z 4E6
British Columbia
Canada
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Winnipeg, R3E 0V9
Manitoba
Canada
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Moncton, E1C 6Z8
New Brunswick
Canada
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Hamilton, L8V 5C2
Ontario
Canada
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London, N6A 4L6
Ontario
Canada
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Oshawa, L1G 2B9
Ontario
Canada
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Ottawa, K1H 8L6
Ontario
Canada
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Toronto, M5G 2M9
Ontario
Canada
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Montreal, H2L 4M1
Quebec
Canada
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Montreal, H3T 1E2
Quebec
Canada
China
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Guangzhou, 510060
Guangdong
China
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Nanjing, 210002
Jiangsu
China
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Beijing, 100021
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China
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Beijing, 100034
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China
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Beijing, 100036
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China
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Beijing, 100853
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China
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Shanghai, 200032
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China
Novartis Investigative Site
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Shanghai, 200127
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China
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Tianjin, 300060
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China
Germany
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Kirchheim, 73230
Baden-Wuerttemberg
Germany
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Sigmaringen, 72488
Baden-Wuerttemberg
Germany
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Stuttgart, 70174
Baden-Wuerttemberg
Germany
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Muenchen, 81377
Bayern
Germany
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Planegg, 82152
Bayern
Germany
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Marburg, 35043
Hessen
Germany
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Offenbach, 63069
Hessen
Germany
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Hannover, 30171
Niedersachsen
Germany
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Aachen, 52074
Nordrhein-Westfalen
Germany
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Bonn, 53127
Nordrhein-Westfalen
Germany
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Dortmund, 44145
Nordrhein-Westfalen
Germany
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Duesseldorf, 40225
Nordrhein-Westfalen
Germany
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Duisburg, 47053
Nordrhein-Westfalen
Germany
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Essen, 45122
Nordrhein-Westfalen
Germany
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Homburg, 66421
Saarland
Germany
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Eisleben, 06295
Sachsen-Anhalt
Germany
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Magdeburg, 39104
Sachsen-Anhalt
Germany
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Dresden, 01307
Sachsen
Germany
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Leipzig, 04103
Sachsen
Germany
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Plauen, 08523
Sachsen
Germany
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Berlin, 10117
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Germany
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Berlin, 10719
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Germany
Ireland
Novartis Investigative Site
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Dublin, 7
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Ireland
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Dublin, 8
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Ireland
Novartis Investigative Site
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Dublin, 9
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Ireland
Novartis Investigative Site
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Galway,
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Ireland
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Tallaght, Dublin, 24
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Ireland
Italy
Novartis Investigative Site
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Napoli, 80131
Campania
Italy
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Meldola (FC), 47014
Emilia-Romagna
Italy
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Ravenna, 48100
Emilia-Romagna
Italy
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Pordenone, 33170
Friuli-Venezia-Giulia
Italy
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Roma, 00152
Lazio
Italy
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Milano, 20141
Lombardia
Italy
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Arezzo, 52100
Toscana
Italy
Japan
Novartis Investigative Site
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Ehime, 791-0280
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Japan
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Fukuoka, 812-0033
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Japan
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Fukuoka, 812-8582
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Japan
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Hokkaido, 060-8543
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Japan
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Hokkaido, 060-8648
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Japan
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Ibaraki, 305-8576
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Japan
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Iwate, 020-8505
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Japan
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Kanagawa, 236-0004
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Japan
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Kyoto, 606-8507
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Japan
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Okayama, 700-8558
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Japan
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Osaka, 565-0871
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Japan
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Osaka, 589-8511
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Japan
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Shizuoka, 431-3192
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Japan
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Tokyo, 104-0045
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Japan
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Tokyo, 113-8655
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Japan
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Tokyo, 135-8550
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Japan
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Tokyo, 160-8582
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Japan
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Tokyo, 162-8666
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Japan
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Tokyo, 173-8606
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Japan
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Yamagata, 990-9585
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Japan
Korea, Republic of
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Daegu, 700-721
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Korea, Republic of
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Daejeon, 301-721
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Korea, Republic of
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Goyang-si, Gyeonggi-Do, 410-769
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Korea, Republic of
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Seoul, 110-744
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Korea, Republic of
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Seoul, 120-752
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Korea, Republic of
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Seoul, 135-710
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Korea, Republic of
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Seoul, 138-736
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Korea, Republic of
Netherlands
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Alkmaar, 1815 JD
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Netherlands
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Amsterdam, 1066 CX
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Netherlands
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Breda, 4819 EV
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Netherlands
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Den Haag, 2545CH
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Netherlands
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Groningen, 9713 GZ
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Netherlands
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Sittard-geleen, 6162 BG
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Netherlands
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Tilburg, 5022 GC
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Netherlands
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Utrecht, 3584 CX
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Netherlands
Spain
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Badalona, 08916
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Spain
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Barakaldo (Vizcaya), 48903
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Spain
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Barcelona, 08036
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Spain
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Gerona, 17007
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Spain
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Madrid, 28033
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Spain
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Madrid, 28040
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Spain
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Madrid, 28041
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Spain
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Pamplona, 31008
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Spain
Sweden
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Lund, SE-221 85
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Sweden
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Stockholm, SE-171 76
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Sweden
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Uppsala, SE-751 85
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Sweden
Taiwan
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Kaohsiung Hsien, 833
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Taiwan
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Taichung, 40402
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Taiwan
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Taichung, 40705
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Taiwan
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Taipei, 10002
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Taiwan
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Taipei, 11217
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Taiwan
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Taoyuan, 333
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Taiwan
United Kingdom
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Bristol, BS2 8ED
Gloucestershire
United Kingdom
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Northwood, HA6 2RN
Middlesex
United Kingdom
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Bebington, Wirral, CH63 4JY
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United Kingdom
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Birmingham, B15 2TH
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United Kingdom
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Cambridge, CB2 0QQ
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United Kingdom
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Glasgow, G12 OYN
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United Kingdom
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Leeds, LS9 7TF
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United Kingdom
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London, EC1A 7BE
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United Kingdom
Novartis Investigative Site
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London, NW3 2QG
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United Kingdom
Novartis Investigative Site
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London, SE1 9RT
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United Kingdom
Novartis Investigative Site
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London, SW3 6JJ
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United Kingdom
Novartis Investigative Site
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Manchester, M20 4BX
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United Kingdom
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Nottingham, NG5 1PB
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United Kingdom
Novartis Investigative Site
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Sheffield, S10 2SJ
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United Kingdom
Novartis Investigative Site
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Swansea, SA2 8QA
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United Kingdom

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