A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC)
PROTECT
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy
3 other identifiers
interventional
1,538
26 countries
312
Brief Summary
This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2010
Longer than P75 for phase_3
312 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2010
CompletedFirst Posted
Study publicly available on registry
November 8, 2010
CompletedStudy Start
First participant enrolled
November 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2019
CompletedResults Posted
Study results publicly available
November 23, 2020
CompletedNovember 23, 2020
October 1, 2020
4.9 years
October 14, 2010
April 15, 2020
October 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.
approximately 5 years
Secondary Outcomes (19)
Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
approximately 8.5 years
DFS Rates at Yearly Time Points With Pazopanib 600 mg Daily Initial Dose vs. Placebo
yearly for 4 years
DFS With Pazopanib vs. Placebo
approximately 5 years
OS With Pazopanib vs. Placebo
approximately 8.5 years
DFS Rates at Yearly Time Points With Pazopanib vs. Placebo
yearly for 4 years
- +14 more secondary outcomes
Study Arms (2)
pazopanib
EXPERIMENTALPazopanib oral agent, administered at 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months. Dose can be reduced, interrupted or discontinued due to adverse events or intolerance.
placebo
PLACEBO COMPARATORplacebo matching pazopanib 200 mg tablets, administered at 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months. Dose can be reduced, interrupted or discontinued due to adverse events or intolerance.
Interventions
Pazopanib monohydrochloride salt was supplied as aqueous, film-coated tablets containing 200 mg of the free base. The 200 mg tablets were oval-shaped and white in color.
Placebo matching pazopanib was supplied as aqueous, film-coated tablets containing 200 mg of the free base. The 200 mg tablets were oval-shaped and white in color.
Eligibility Criteria
You may qualify if:
- Signed written informed consent
- Diagnosis of RCC with clear-cell or predominant clear-cell histology
- Subjects with non-metastatic disease (M0) fulfilling any of the following combinations of pathologic staging based on American Joint Committee on Cancer (AJCC) TNM staging version 2010 and Fuhrman nuclear grading.
- pT2, G3 or G4, N0; or,
- pT3, G any, N0; or,
- pT4, G any, N0; or,
- pT any, G any, N1
- Fulfill all of the following criteria of disease-free status at baseline:
- Had complete gross surgical resection of all RCC via radical or partial nephrectomy using either open or laparoscopic technique.
- Baseline imaging of chest, abdomen and pelvis shows no metastasis or residual tumor lesions as confirmed centrally by an independent radiologist.
- Received no prior adjuvant or neo-adjuvant treatment for RCC
- Recovered from nephrectomy: any surgery related toxicities should be reduced to ≤ grade 1 per NCI Common Terminology Criteria for Adverse Events (CTCAE) (Version 4)
- Karnofsky performance scale (KPS) of ≥ 80
- Adequate organ system function
You may not qualify if:
- History of another malignancy. Exception: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- Active peptic ulcer disease
- Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), 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
- Active diarrhea of any grade
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
- Malabsorption syndrome
- Major resection of the stomach or small bowel
- History of human immunodeficiency virus (HIV) infection
- History of active hepatitis
- Presence of uncontrolled infection.
- History of any one or more of the following cardiovascular conditions within the past 6 months:
- Cardiac angioplasty or stenting
- Myocardial infarction
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (312)
Novartis Investigative Site
Jonesboro, Arkansas, 72401, United States
Novartis Investigative Site
Antioch, California, 94531, United States
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Beverly Hills, California, 90211, United States
Novartis Investigative Site
Fresno, California, 93720, United States
Novartis Investigative Site
La Jolla, California, 92093, United States
Novartis Investigative Site
Los Angeles, California, 90033, United States
Novartis Investigative Site
Los Angeles, California, 90048-0750, United States
Novartis Investigative Site
Los Angeles, California, 90095, United States
Novartis Investigative Site
Oakland, California, 94611, United States
Novartis Investigative Site
Sacramento, California, 95825, United States
Novartis Investigative Site
San Francisco, California, 94115, United States
Novartis Investigative Site
South San Francisco, California, 94080, United States
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Stanford, California, 94305, United States
Novartis Investigative Site
Vallejo, California, 94589, United States
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Fort Collins, Colorado, 80528, United States
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Washington D.C., District of Columbia, 20007, United States
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Fort Myers, Florida, 33916, United States
Novartis Investigative Site
Tampa, Florida, 33612, United States
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Athens, Georgia, 30607, United States
Novartis Investigative Site
Macon, Georgia, 31201, United States
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Chicago, Illinois, 60637, United States
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Indianapolis, Indiana, 46202, United States
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Iowa City, Iowa, 52242, United States
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Baltimore, Maryland, 21231, United States
Novartis Investigative Site
Boston, Massachusetts, 02114, United States
Novartis Investigative Site
Boston, Massachusetts, 02115, United States
Novartis Investigative Site
Boston, Massachusetts, 02215, United States
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Burlington, Massachusetts, 01805, United States
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Detroit, Michigan, 48201, United States
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Rochester, Minnesota, 55905, United States
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Saint Louis Park, Minnesota, 55416, United States
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St Louis, Missouri, 63110, United States
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Lincoln, Nebraska, 68510, United States
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Omaha, Nebraska, 68114, United States
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Omaha, Nebraska, 68118, United States
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Las Vegas, Nevada, 89169, United States
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Hackensack, New Jersey, 07601, United States
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Albany, New York, 12206, United States
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Buffalo, New York, 14263, United States
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New York, New York, 10003, United States
Novartis Investigative Site
New York, New York, 10021, United States
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New York, New York, 10065, United States
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Durham, North Carolina, 27710, United States
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Cincinnati, Ohio, 45242, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Portland, Oregon, 97213, United States
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Springfield, Oregon, 97477, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19106, United States
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Philadelphia, Pennsylvania, 19107, United States
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Philadelphia, Pennsylvania, 19111, United States
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Providence, Rhode Island, 02903, United States
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Providence, Rhode Island, 02906, United States
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Charleston, South Carolina, 29425, United States
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Chattanooga, Tennessee, 37404, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37232, United States
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Bedford, Texas, 76022, United States
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Dallas, Texas, 75246, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78217, United States
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Tyler, Texas, 75702, United States
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Hampton, Virginia, 23666, United States
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Richmond, Virginia, 23230, United States
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Virginia Beach, Virginia, 23462, United States
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Seattle, Washington, 98109, United States
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Berazategui, Buenos Aires, B1880BBF, Argentina
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Capital Federal, Buenos Aires, C1426ANZ, Argentina
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Ciudad Aut6noma de Buenos Aires, Buenos Aires, C1050AAK, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH, Argentina
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Quilmes, Buenos Aires, 1878, Argentina
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Córdoba, Córdoba Province, X5003DCE, Argentina
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Córdoba, Córdoba Province, X5006HBF, Argentina
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Cipolletti, Río Negro Province, R8324EMB, Argentina
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Rosario, Santa Fe Province, S2000KZE, Argentina
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San Miguel de Tucumán, T4000IAK, Argentina
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Santa Fe, 3000, Argentina
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Salzburg, 5020, Austria
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Salzburg, A-5020, Austria
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Vienna, 1130, Austria
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Vienna, A-1090, Austria
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Hasselt, 3500, Belgium
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Jette, 1090, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Roeselare, 8800, Belgium
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Wilrijk, 2610, Belgium
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Belo Horizonte, Minas Gerais, 30130-100, Brazil
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Curitiba, Paraná, 81520-060, Brazil
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Ijuí, Rio Grande do Sul, 98700-000, Brazil
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Porto Alegre, Rio Grande do Sul, 90610000, Brazil
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Barretos, São Paulo, 14784-400, Brazil
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Campinas, São Paulo, 13083-970, Brazil
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São Paulo, São Paulo, 01246-000, Brazil
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São Paulo, São Paulo, 01308-050, Brazil
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São Paulo, São Paulo, 05651-901, Brazil
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São Paulo, São Paulo, 08270-070, Brazil
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Rio de Janeiro, 20 551-030, Brazil
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Rio de Janeiro, 20231-050, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Moncton, New Brunswick, E1C 6Z8, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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London, Ontario, N6A 4L6, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Québec, Quebec, G1R 2J6, Canada
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Viña del Mar, Región de Valparaíso, 254-0364, Chile
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Santiago, Región Metro de Santiago, 7500921, Chile
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Wuhan, Hubei, 430030, China
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Hangzhou, Zhejiang, 310003, China
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Hangzhou, Zhejiang, 310009, China
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Beijing, 100021, China
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Beijing, 100034, China
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Beijing, 100191, China
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Beijing, 100853, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shanghai, 200040, China
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Shanghai, 200127, China
Novartis Investigative Site
Tianjin, 300060, China
Novartis Investigative Site
Brno, 656 53, Czechia
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Brno, 656 91, Czechia
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Hradec Králové, 500 05, Czechia
Novartis Investigative Site
Nový Jičín, 741 01, Czechia
Novartis Investigative Site
Olomouc, 775 20, Czechia
Novartis Investigative Site
Ostrava - Poruba, 708 52, Czechia
Novartis Investigative Site
Pilsen, 304 60, Czechia
Novartis Investigative Site
Prague, 12808, Czechia
Novartis Investigative Site
Prague, 180 00, Czechia
Novartis Investigative Site
Ústí nad Labem, 40113, Czechia
Novartis Investigative Site
Aarhus, 8000 Aarhus C, Denmark
Novartis Investigative Site
Dk-2730 Herlev, 2730, Denmark
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Odense C, 5000, Denmark
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Angers, 49055, France
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Besançon, 25030, France
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Bordeaux, 33075, France
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Caen, 14076, France
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Hyères, 83400, France
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Le Mans, 72000, France
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Marseille, 13385, France
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Montpellier, 34295, France
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Paris, 75014, France
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Paris, 75908, France
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Poitiers, 86021, France
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Reims, 51100, France
Novartis Investigative Site
Rennes, 35042, France
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Saint-Herblain, 44805, France
Novartis Investigative Site
Strasbourg, 67085, France
Novartis Investigative Site
Strasbourg, 67091, France
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Toulouse, 31076, France
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Tours, 37044, France
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Kirchheim, Baden-Wurttemberg, 73230, Germany
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Ravensburg, Baden-Wurttemberg, 88212, Germany
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Sigmaringen, Baden-Wurttemberg, 72488, Germany
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Stuttgart, Baden-Wurttemberg, 70174, Germany
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Tübingen, Baden-Wurttemberg, 72076, Germany
Novartis Investigative Site
Ulm, Baden-Wurttemberg, 89075, Germany
Novartis Investigative Site
Erlangen, Bavaria, 91054, Germany
Novartis Investigative Site
Fürth, Bavaria, 90766, Germany
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Munich, Bavaria, 81675, Germany
Novartis Investigative Site
Regensburg, Bavaria, 93053, Germany
Novartis Investigative Site
Weiden, Bavaria, 92637, Germany
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Frankfurt am Main, Hesse, 60590, Germany
Novartis Investigative Site
Marburg, Hesse, 35043, Germany
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Offenbach, Hesse, 63069, Germany
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Braunschweig, Lower Saxony, 38126, Germany
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Goslar, Lower Saxony, 38642, Germany
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Hanover, Lower Saxony, 30625, Germany
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Aachen, North Rhine-Westphalia, 52074, Germany
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Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany
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Bonn, North Rhine-Westphalia, 53127, Germany
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Duisburg, North Rhine-Westphalia, 47179, Germany
Novartis Investigative Site
Essen, North Rhine-Westphalia, 45122, Germany
Novartis Investigative Site
Mönchengladbach, North Rhine-Westphalia, 41063, Germany
Novartis Investigative Site
Münster, North Rhine-Westphalia, 48149, Germany
Novartis Investigative Site
Neuss, North Rhine-Westphalia, 41464, Germany
Novartis Investigative Site
Velbert, North Rhine-Westphalia, 42551, Germany
Novartis Investigative Site
Mainz, Rhineland-Palatinate, 55131, Germany
Novartis Investigative Site
Homburg, Saarland, 66421, Germany
Novartis Investigative Site
Chemnitz, Saxony, 09130, Germany
Novartis Investigative Site
Leipzig, Saxony, 04277, Germany
Novartis Investigative Site
Plauen, Saxony, 08523, Germany
Novartis Investigative Site
Dessau, Saxony-Anhalt, 06846, Germany
Novartis Investigative Site
Eisleben Lutherstadt, Saxony-Anhalt, 06295, Germany
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Halle, Saxony-Anhalt, 06120, Germany
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Lübeck, Schleswig-Holstein, 23566, Germany
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Jena, Thuringia, 07768, Germany
Novartis Investigative Site
Berlin, 10719, Germany
Novartis Investigative Site
Berlin, 10967, Germany
Novartis Investigative Site
Berlin, 12200, Germany
Novartis Investigative Site
Bremen, 28177, Germany
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Hamburg, 20246, Germany
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Athens, 115 22, Greece
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Heraklion, Crete, 71100, Greece
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Pátrai, 26504, Greece
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Thessaloniki, Greece
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Budapest, 1082, Hungary
Novartis Investigative Site
Budapest, 1097, Hungary
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Budapest, 1122, Hungary
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Miskolc, 3526, Hungary
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Nyíregyháza, 4400, Hungary
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Szombathely, 9700, Hungary
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Cork, Ireland
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Dublin, 7, Ireland
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Dublin, 9, Ireland
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Galway, Ireland
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Tallaght, Dublin, 24, Ireland
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Petah Tikva, 49100, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 64239, Israel
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Zrifin, 70300, Israel
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Napoli, Campania, 80131, Italy
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Bologna, Emilia-Romagna, 40138, Italy
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Meldola (FC), Emilia-Romagna, 47014, Italy
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Modena, Emilia-Romagna, 41100, Italy
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Rome, Lazio, 00144, Italy
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Rome, Lazio, 00152, Italy
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Milan, Lombardy, 20133, Italy
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Rozzano (MI), Lombardy, 20089, Italy
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Candiolo (TO), Piedmont, 10060, Italy
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Arezzo, Tuscany, 52100, Italy
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Terni, Umbria, 05100, Italy
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Negrar, Veneto, 37024, Italy
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Fukuoka, 812-8582, Japan
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Hokkaido, 060-8543, Japan
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Hokkaido, 060-8648, Japan
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Kanagawa, 236-0004, Japan
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Okayama, 700-8558, Japan
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Osaka, 589-8511, Japan
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Shizuoka, 431-3192, Japan
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Tokyo, 113-8603, Japan
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Tokyo, 160-8582, Japan
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Tokyo, 162-8666, Japan
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Yamagata, 990-9585, Japan
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Luxembourg, 1210, Luxembourg
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Gdansk, 80-219, Poland
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Konin, 62-500, Poland
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Krakow, 31-108, Poland
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Krakow, 31-115, Poland
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Lublin, 20-090, Poland
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Warsaw, 02-776, Poland
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Warsaw, 02-781, Poland
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Warsaw, 04-125, Poland
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Wroclaw, 50-556, Poland
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Arkhangelsk, 163045, Russia
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Barnaul, 656049, Russia
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Chelyabinsk, 454087, Russia
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Kazan', 420029, Russia
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Moscow, 115478, Russia
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Moscow, 117997, Russia
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Obninsk, 249036, Russia
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Omsk, 644013, Russia
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Rostov-on-Don, Russia
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Ryazan, 390011, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, Russia
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Stavropol, 355047, Russia
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Ufa, 450054, Russia
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Yekaterinburg, 620102, Russia
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Banská Bystrica, 975 17, Slovakia
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Bratislava, 833 05, Slovakia
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Košice, 041 66, Slovakia
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Martin, 036 59, Slovakia
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Žilina, 012 07, Slovakia
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Daejeon, 35015, South Korea
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Goyang-si, Gyeonggi-do, 410-769, South Korea
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Jeonju, 54907, South Korea
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Seongnam-si Gyeonggi-do, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 06351, South Korea
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Seoul, 120-752, South Korea
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Seoul, 136-705, South Korea
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Songpa-gu, Seoul, 138-736, South Korea
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Badalona, 08916, Spain
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Barcelona, 08035, Spain
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Córdoba, 14004, Spain
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Dos Hermanas (Sevilla), 41700, Spain
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Madrid, 28007, Spain
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Madrid, 28033, Spain
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Madrid, 28041, Spain
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Madrid, 28050, Spain
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Málaga, 29010, Spain
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Oviedo, 33006, Spain
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Seville, 41013, Spain
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Valencia, 46009, Spain
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06590, Turkey (Türkiye)
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Istanbul, 34390, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Brighton, BN2 5BE, United Kingdom
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Cornwall, TR1 3LJ, United Kingdom
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Guildford, GU2 7XX, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE1 9RT, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Preston, PR2 9HT, United Kingdom
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Swansea, SA2 8QA, United Kingdom
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Wolverhampton, WV10 0QP, United Kingdom
Related Publications (2)
Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarba JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.
PMID: 20100962BACKGROUNDMotzer RJ, Russo P, Haas N, Doehn C, Donskov F, Gross-Goupil M, Varlamov S, Kopyltsov E, Lee JL, Lim HY, Melichar B, Zemanova M, Rini B, Choueiri TK, Wood L, Reaume MN, Stenzl A, Chowdhury S, McDermott R, Michael A, Izquierdo M, Aimone P, Zhang H, Sternberg CN; PROTECT study investigators. Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma: Final Overall Survival Analysis of the Phase 3 PROTECT Trial. Eur Urol. 2021 Mar;79(3):334-338. doi: 10.1016/j.eururo.2020.12.029. Epub 2021 Jan 15.
PMID: 33461782DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2010
First Posted
November 8, 2010
Study Start
November 30, 2010
Primary Completion
October 15, 2015
Study Completion
April 15, 2019
Last Updated
November 23, 2020
Results First Posted
November 23, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com