A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC)

NCT ID: NCT01235962

Last Updated: 2020-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1538 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2019-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective of this ongoing study was to evaluate DFS with pazopanib 600 mg daily initial dose as compared with placebo as adjuvant therapy for subjects with localized/locally advanced RCC following nephrectomy.

Subjects with locally recurrent renal cell carcinoma (RCC), bilateral RCC, or history of another malignancy were excluded from enrolling in the study.

The study was comprised of three successive study periods: 1) the Screening/Baseline period, 2) the study treatment period, and 3) the DFS /OS follow-up period. The Screening/Baseline period had a maximum duration of 12 weeks from the date of nephrectomy to the date of randomization.

After a subject met all the eligibility criteria and completed all the required baseline assessments, the subject was randomized in a 1:1 ratio to receive once daily blinded treatment with either pazopanib 600 mg as initial dose or matching placebo based on pre-defined stratification factors.

Subjects received continuous daily treatment until completion of the 12-month treatment period, disease recurrence, or unacceptable toxicity/intolerance. Subsequent adjuvant therapies for RCC were not allowed. During the study treatment and DFS follow-up periods, subjects received routine safety and efficacy assessments.

The study treatment period was 12 months. Subjects received continuous daily treatment until completion of the 12 month treatment period, disease recurrence, or unacceptable toxicity/intolerance. Subsequent adjuvant therapies for RCC were not allowed.

All subjects, regardless of study treatment status (i.e. premature discontinuation or completion of the 12-month treatment), were to be followed with routine imaging assessments and remain blinded until objective evidence of disease recurrence was obtained or until the study achieved the required number of events for the primary endpoint of DFS (319 events). After objective evidence of disease recurrence was obtained, subjects could be unblinded and received the first-line treatment for metastatic RCC per local standard of care.

All subjects were off treatment for at least 4 years at the end of study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Cell Carcinoma (RCC) Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

anti-angiogenic agent renal cell carcinoma pazopanib adjuvant therapy VEGFR inhibitor localized or locally advanced renal cell carcinoma (RCC) following nephrectomy advanced RCC Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pazopanib

Pazopanib 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.

Group Type EXPERIMENTAL

pazopanib

Intervention Type DRUG

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.

pazopanib

Intervention Type DRUG

Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

placebo

placebo 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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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.

placebo

Intervention Type DRUG

placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pazopanib

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.

Intervention Type DRUG

placebo

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.

Intervention Type DRUG

pazopanib

Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

Intervention Type DRUG

placebo

placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PZP034 Votrient

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Unstable angina
* Coronary artery bypass graft surgery
* Symptomatic peripheral vascular disease
* History of Class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure
* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
* Corrected QT interval (QTc) \> 480 milliseconds (msec)
* Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg.

Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be \<140/90 mmHg in order for a subject to be eligible for the study (see Section 7.6.2 for instruction on blood pressure measurement and obtaining mean blood pressure values).

* Evidence of active bleeding or bleeding diathesis
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
* Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study treatment and for the duration of the study.
* Concurrent therapy given to treat cancer including treatment with an investigational agent or concurrent participation in another clinical trial involving anti-cancer investigational drug.
* Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
* Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or excipients that in the opinion of the investigator contraindicates their participation.
* Prior or current use of systemic anti-VEGF inhibitors, cytokines (e.g. interferon, interleukin 2).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Jonesboro, Arkansas, United States

Site Status

Novartis Investigative Site

Antioch, California, United States

Site Status

Novartis Investigative Site

Beverly Hills, California, United States

Site Status

Novartis Investigative Site

Fresno, California, United States

Site Status

Novartis Investigative Site

La Jolla, California, United States

Site Status

Novartis Investigative Site

Los Angeles, California, United States

Site Status

Novartis Investigative Site

Los Angeles, California, United States

Site Status

Novartis Investigative Site

Los Angeles, California, United States

Site Status

Novartis Investigative Site

Oakland, California, United States

Site Status

Novartis Investigative Site

Sacramento, California, United States

Site Status

Novartis Investigative Site

San Francisco, California, United States

Site Status

Novartis Investigative Site

South San Francisco, California, United States

Site Status

Novartis Investigative Site

Stanford, California, United States

Site Status

Novartis Investigative Site

Vallejo, California, United States

Site Status

Novartis Investigative Site

Fort Collins, Colorado, United States

Site Status

Novartis Investigative Site

Washington D.C., District of Columbia, United States

Site Status

Novartis Investigative Site

Fort Myers, Florida, United States

Site Status

Novartis Investigative Site

Tampa, Florida, United States

Site Status

Novartis Investigative Site

Athens, Georgia, United States

Site Status

Novartis Investigative Site

Macon, Georgia, United States

Site Status

Novartis Investigative Site

Chicago, Illinois, United States

Site Status

Novartis Investigative Site

Indianapolis, Indiana, United States

Site Status

Novartis Investigative Site

Iowa City, Iowa, United States

Site Status

Novartis Investigative Site

Baltimore, Maryland, United States

Site Status

Novartis Investigative Site

Boston, Massachusetts, United States

Site Status

Novartis Investigative Site

Boston, Massachusetts, United States

Site Status

Novartis Investigative Site

Boston, Massachusetts, United States

Site Status

Novartis Investigative Site

Burlington, Massachusetts, United States

Site Status

Novartis Investigative Site

Detroit, Michigan, United States

Site Status

Novartis Investigative Site

Rochester, Minnesota, United States

Site Status

Novartis Investigative Site

Saint Louis Park, Minnesota, United States

Site Status

Novartis Investigative Site

St Louis, Missouri, United States

Site Status

Novartis Investigative Site

Lincoln, Nebraska, United States

Site Status

Novartis Investigative Site

Omaha, Nebraska, United States

Site Status

Novartis Investigative Site

Omaha, Nebraska, United States

Site Status

Novartis Investigative Site

Las Vegas, Nevada, United States

Site Status

Novartis Investigative Site

Hackensack, New Jersey, United States

Site Status

Novartis Investigative Site

Albany, New York, United States

Site Status

Novartis Investigative Site

Buffalo, New York, United States

Site Status

Novartis Investigative Site

New York, New York, United States

Site Status

Novartis Investigative Site

New York, New York, United States

Site Status

Novartis Investigative Site

New York, New York, United States

Site Status

Novartis Investigative Site

Durham, North Carolina, United States

Site Status

Novartis Investigative Site

Cincinnati, Ohio, United States

Site Status

Novartis Investigative Site

Cleveland, Ohio, United States

Site Status

Novartis Investigative Site

Columbus, Ohio, United States

Site Status

Novartis Investigative Site

Portland, Oregon, United States

Site Status

Novartis Investigative Site

Springfield, Oregon, United States

Site Status

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Novartis Investigative Site

Providence, Rhode Island, United States

Site Status

Novartis Investigative Site

Providence, Rhode Island, United States

Site Status

Novartis Investigative Site

Charleston, South Carolina, United States

Site Status

Novartis Investigative Site

Chattanooga, Tennessee, United States

Site Status

Novartis Investigative Site

Memphis, Tennessee, United States

Site Status

Novartis Investigative Site

Nashville, Tennessee, United States

Site Status

Novartis Investigative Site

Nashville, Tennessee, United States

Site Status

Novartis Investigative Site

Bedford, Texas, United States

Site Status

Novartis Investigative Site

Dallas, Texas, United States

Site Status

Novartis Investigative Site

Houston, Texas, United States

Site Status

Novartis Investigative Site

Houston, Texas, United States

Site Status

Novartis Investigative Site

San Antonio, Texas, United States

Site Status

Novartis Investigative Site

Tyler, Texas, United States

Site Status

Novartis Investigative Site

Hampton, Virginia, United States

Site Status

Novartis Investigative Site

Richmond, Virginia, United States

Site Status

Novartis Investigative Site

Virginia Beach, Virginia, United States

Site Status

Novartis Investigative Site

Seattle, Washington, United States

Site Status

Novartis Investigative Site

Berazategui, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Capital Federal, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Ciudad Aut6noma de Buenos Aires, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Quilmes, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Site Status

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Site Status

Novartis Investigative Site

Cipolletti, Río Negro Province, Argentina

Site Status

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Site Status

Novartis Investigative Site

San Miguel de Tucumán, , Argentina

Site Status

Novartis Investigative Site

Santa Fe, , Argentina

Site Status

Novartis Investigative Site

Graz, , Austria

Site Status

Novartis Investigative Site

Innsbruck, , Austria

Site Status

Novartis Investigative Site

Salzburg, , Austria

Site Status

Novartis Investigative Site

Salzburg, , Austria

Site Status

Novartis Investigative Site

Vienna, , Austria

Site Status

Novartis Investigative Site

Vienna, , Austria

Site Status

Novartis Investigative Site

Hasselt, , Belgium

Site Status

Novartis Investigative Site

Jette, , Belgium

Site Status

Novartis Investigative Site

Liège, , Belgium

Site Status

Novartis Investigative Site

Namur, , Belgium

Site Status

Novartis Investigative Site

Roeselare, , Belgium

Site Status

Novartis Investigative Site

Wilrijk, , Belgium

Site Status

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Site Status

Novartis Investigative Site

Curitiba, Paraná, Brazil

Site Status

Novartis Investigative Site

Ijuí, Rio Grande do Sul, Brazil

Site Status

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Novartis Investigative Site

Barretos, São Paulo, Brazil

Site Status

Novartis Investigative Site

Campinas, São Paulo, Brazil

Site Status

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status

Novartis Investigative Site

Rio de Janeiro, , Brazil

Site Status

Novartis Investigative Site

Rio de Janeiro, , Brazil

Site Status

Novartis Investigative Site

Calgary, Alberta, Canada

Site Status

Novartis Investigative Site

Edmonton, Alberta, Canada

Site Status

Novartis Investigative Site

Vancouver, British Columbia, Canada

Site Status

Novartis Investigative Site

Moncton, New Brunswick, Canada

Site Status

Novartis Investigative Site

Halifax, Nova Scotia, Canada

Site Status

Novartis Investigative Site

Hamilton, Ontario, Canada

Site Status

Novartis Investigative Site

London, Ontario, Canada

Site Status

Novartis Investigative Site

Oshawa, Ontario, Canada

Site Status

Novartis Investigative Site

Ottawa, Ontario, Canada

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Québec, Quebec, Canada

Site Status

Novartis Investigative Site

Viña del Mar, Región de Valparaíso, Chile

Site Status

Novartis Investigative Site

Santiago, Región Metro de Santiago, Chile

Site Status

Novartis Investigative Site

Wuhan, Hubei, China

Site Status

Novartis Investigative Site

Hangzhou, Zhejiang, China

Site Status

Novartis Investigative Site

Hangzhou, Zhejiang, China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Tianjin, , China

Site Status

Novartis Investigative Site

Brno, , Czechia

Site Status

Novartis Investigative Site

Brno, , Czechia

Site Status

Novartis Investigative Site

Hradec Králové, , Czechia

Site Status

Novartis Investigative Site

Nový Jičín, , Czechia

Site Status

Novartis Investigative Site

Olomouc, , Czechia

Site Status

Novartis Investigative Site

Ostrava - Poruba, , Czechia

Site Status

Novartis Investigative Site

Pilsen, , Czechia

Site Status

Novartis Investigative Site

Prague, , Czechia

Site Status

Novartis Investigative Site

Prague, , Czechia

Site Status

Novartis Investigative Site

Ústí nad Labem, , Czechia

Site Status

Novartis Investigative Site

Aarhus, , Denmark

Site Status

Novartis Investigative Site

Dk-2730 Herlev, , Denmark

Site Status

Novartis Investigative Site

Odense C, , Denmark

Site Status

Novartis Investigative Site

Angers, , France

Site Status

Novartis Investigative Site

Besançon, , France

Site Status

Novartis Investigative Site

Bordeaux, , France

Site Status

Novartis Investigative Site

Caen, , France

Site Status

Novartis Investigative Site

Hyères, , France

Site Status

Novartis Investigative Site

Le Mans, , France

Site Status

Novartis Investigative Site

Marseille, , France

Site Status

Novartis Investigative Site

Montpellier, , France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Poitiers, , France

Site Status

Novartis Investigative Site

Reims, , France

Site Status

Novartis Investigative Site

Rennes, , France

Site Status

Novartis Investigative Site

Saint-Herblain, , France

Site Status

Novartis Investigative Site

Strasbourg, , France

Site Status

Novartis Investigative Site

Strasbourg, , France

Site Status

Novartis Investigative Site

Toulouse, , France

Site Status

Novartis Investigative Site

Tours, , France

Site Status

Novartis Investigative Site

Kirchheim, Baden-Wurttemberg, Germany

Site Status

Novartis Investigative Site

Ravensburg, Baden-Wurttemberg, Germany

Site Status

Novartis Investigative Site

Sigmaringen, Baden-Wurttemberg, Germany

Site Status

Novartis Investigative Site

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Novartis Investigative Site

Tübingen, Baden-Wurttemberg, Germany

Site Status

Novartis Investigative Site

Ulm, Baden-Wurttemberg, Germany

Site Status

Novartis Investigative Site

Erlangen, Bavaria, Germany

Site Status

Novartis Investigative Site

Fürth, Bavaria, Germany

Site Status

Novartis Investigative Site

Munich, Bavaria, Germany

Site Status

Novartis Investigative Site

Regensburg, Bavaria, Germany

Site Status

Novartis Investigative Site

Weiden, Bavaria, Germany

Site Status

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Site Status

Novartis Investigative Site

Marburg, Hesse, Germany

Site Status

Novartis Investigative Site

Offenbach, Hesse, Germany

Site Status

Novartis Investigative Site

Braunschweig, Lower Saxony, Germany

Site Status

Novartis Investigative Site

Goslar, Lower Saxony, Germany

Site Status

Novartis Investigative Site

Hanover, Lower Saxony, Germany

Site Status

Novartis Investigative Site

Aachen, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Bergisch Gladbach, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Bonn, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Duisburg, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Essen, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Mönchengladbach, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Münster, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Neuss, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Velbert, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Mainz, Rhineland-Palatinate, Germany

Site Status

Novartis Investigative Site

Homburg, Saarland, Germany

Site Status

Novartis Investigative Site

Chemnitz, Saxony, Germany

Site Status

Novartis Investigative Site

Leipzig, Saxony, Germany

Site Status

Novartis Investigative Site

Plauen, Saxony, Germany

Site Status

Novartis Investigative Site

Dessau, Saxony-Anhalt, Germany

Site Status

Novartis Investigative Site

Eisleben Lutherstadt, Saxony-Anhalt, Germany

Site Status

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany

Site Status

Novartis Investigative Site

Lübeck, Schleswig-Holstein, Germany

Site Status

Novartis Investigative Site

Jena, Thuringia, Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Bremen, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Athens, , Greece

Site Status

Novartis Investigative Site

Heraklion, Crete, , Greece

Site Status

Novartis Investigative Site

Pátrai, , Greece

Site Status

Novartis Investigative Site

Thessaloniki, , Greece

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Miskolc, , Hungary

Site Status

Novartis Investigative Site

Nyíregyháza, , Hungary

Site Status

Novartis Investigative Site

Szombathely, , Hungary

Site Status

Novartis Investigative Site

Cork, , Ireland

Site Status

Novartis Investigative Site

Dublin, , Ireland

Site Status

Novartis Investigative Site

Dublin, , Ireland

Site Status

Novartis Investigative Site

Galway, , Ireland

Site Status

Novartis Investigative Site

Tallaght, Dublin, , Ireland

Site Status

Novartis Investigative Site

Haifa, , Israel

Site Status

Novartis Investigative Site

Jerusalem, , Israel

Site Status

Novartis Investigative Site

Petah Tikva, , Israel

Site Status

Novartis Investigative Site

Rehovot, , Israel

Site Status

Novartis Investigative Site

Tel Aviv, , Israel

Site Status

Novartis Investigative Site

Zrifin, , Israel

Site Status

Novartis Investigative Site

Napoli, Campania, Italy

Site Status

Novartis Investigative Site

Bologna, Emilia-Romagna, Italy

Site Status

Novartis Investigative Site

Meldola (FC), Emilia-Romagna, Italy

Site Status

Novartis Investigative Site

Modena, Emilia-Romagna, Italy

Site Status

Novartis Investigative Site

Rome, Lazio, Italy

Site Status

Novartis Investigative Site

Rome, Lazio, Italy

Site Status

Novartis Investigative Site

Milan, Lombardy, Italy

Site Status

Novartis Investigative Site

Rozzano (MI), Lombardy, Italy

Site Status

Novartis Investigative Site

Candiolo (TO), Piedmont, Italy

Site Status

Novartis Investigative Site

Arezzo, Tuscany, Italy

Site Status

Novartis Investigative Site

Terni, Umbria, Italy

Site Status

Novartis Investigative Site

Negrar, Veneto, Italy

Site Status

Novartis Investigative Site

Fukuoka, , Japan

Site Status

Novartis Investigative Site

Hokkaido, , Japan

Site Status

Novartis Investigative Site

Hokkaido, , Japan

Site Status

Novartis Investigative Site

Kanagawa, , Japan

Site Status

Novartis Investigative Site

Okayama, , Japan

Site Status

Novartis Investigative Site

Osaka, , Japan

Site Status

Novartis Investigative Site

Shizuoka, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Novartis Investigative Site

Yamagata, , Japan

Site Status

Novartis Investigative Site

Luxembourg, , Luxembourg

Site Status

Novartis Investigative Site

Gdansk, , Poland

Site Status

Novartis Investigative Site

Konin, , Poland

Site Status

Novartis Investigative Site

Krakow, , Poland

Site Status

Novartis Investigative Site

Krakow, , Poland

Site Status

Novartis Investigative Site

Lublin, , Poland

Site Status

Novartis Investigative Site

Warsaw, , Poland

Site Status

Novartis Investigative Site

Warsaw, , Poland

Site Status

Novartis Investigative Site

Warsaw, , Poland

Site Status

Novartis Investigative Site

Wroclaw, , Poland

Site Status

Novartis Investigative Site

Arkhangelsk, , Russia

Site Status

Novartis Investigative Site

Barnaul, , Russia

Site Status

Novartis Investigative Site

Chelyabinsk, , Russia

Site Status

Novartis Investigative Site

Kazan', , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Obninsk, , Russia

Site Status

Novartis Investigative Site

Omsk, , Russia

Site Status

Novartis Investigative Site

Rostov-on-Don, , Russia

Site Status

Novartis Investigative Site

Ryazan, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Stavropol, , Russia

Site Status

Novartis Investigative Site

Ufa, , Russia

Site Status

Novartis Investigative Site

Yekaterinburg, , Russia

Site Status

Novartis Investigative Site

Banská Bystrica, , Slovakia

Site Status

Novartis Investigative Site

Bratislava, , Slovakia

Site Status

Novartis Investigative Site

Košice, , Slovakia

Site Status

Novartis Investigative Site

Martin, , Slovakia

Site Status

Novartis Investigative Site

Žilina, , Slovakia

Site Status

Novartis Investigative Site

Daejeon, , South Korea

Site Status

Novartis Investigative Site

Goyang-si, Gyeonggi-do, , South Korea

Site Status

Novartis Investigative Site

Jeonju, , South Korea

Site Status

Novartis Investigative Site

Seongnam-si Gyeonggi-do, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Songpa-gu, Seoul, , South Korea

Site Status

Novartis Investigative Site

Badalona, , Spain

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Córdoba, , Spain

Site Status

Novartis Investigative Site

Dos Hermanas (Sevilla), , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Málaga, , Spain

Site Status

Novartis Investigative Site

Oviedo, , Spain

Site Status

Novartis Investigative Site

Seville, , Spain

Site Status

Novartis Investigative Site

Valencia, , Spain

Site Status

Novartis Investigative Site

Ankara, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Ankara, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Istanbul, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Brighton, , United Kingdom

Site Status

Novartis Investigative Site

Cornwall, , United Kingdom

Site Status

Novartis Investigative Site

Guildford, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

Manchester, , United Kingdom

Site Status

Novartis Investigative Site

Preston, , United Kingdom

Site Status

Novartis Investigative Site

Swansea, , United Kingdom

Site Status

Novartis Investigative Site

Wolverhampton, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Austria Belgium Brazil Canada Chile China Czechia Denmark France Germany Greece Hungary Ireland Israel Italy Japan Luxembourg Poland Russia Slovakia South Korea Spain Turkey (Türkiye) United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20100962 (View on PubMed)

Motzer 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.

Reference Type DERIVED
PMID: 33461782 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-020965-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CPZP034D2301

Identifier Type: OTHER

Identifier Source: secondary_id

113387

Identifier Type: -

Identifier Source: org_study_id