AzTrials
AzTrials

Renal Cell Carcinoma (RCC)Phase 3PROTECTNCT01235962

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

A Phase 3 study testing pazopanib in people with Renal Cell Carcinoma (RCC) and Cancer, run by Novartis Pharmaceuticals at 312 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma (RCC), Cancer
What is being tested?
pazopanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,538 participants
Where
312 sitesin 26 countries
Study dates
30 Nov 2010to 15 Apr 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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).

Trial locations and contacts

312 sites in 26 countries.

312 sites in 26 countries

United States69 sites

  • Novartis Investigative Site

    Albany, New York, 12206

  • Novartis Investigative Site

    Antioch, California, 94531

  • Novartis Investigative Site

    Athens, Georgia, 30607

  • Novartis Investigative Site

    Baltimore, Maryland, 21231

  • Novartis Investigative Site

    Bedford, Texas, 76022

  • Novartis Investigative Site

    Beverly Hills, California, 90211

  • Novartis Investigative Site

    Boston, Massachusetts, 02114

  • Novartis Investigative Site

    Boston, Massachusetts, 02115

  • Novartis Investigative Site

    Boston, Massachusetts, 02215

  • Novartis Investigative Site

    Buffalo, New York, 14263

  • Novartis Investigative Site

    Burlington, Massachusetts, 01805

  • Novartis Investigative Site

    Charleston, South Carolina, 29425

  • Novartis Investigative Site

    Chattanooga, Tennessee, 37404

  • Novartis Investigative Site

    Chicago, Illinois, 60637

  • Novartis Investigative Site

    Cincinnati, Ohio, 45242

  • Novartis Investigative Site

    Cleveland, Ohio, 44195

  • Novartis Investigative Site

    Columbus, Ohio, 43210

  • Novartis Investigative Site

    Dallas, Texas, 75246

  • Novartis Investigative Site

    Detroit, Michigan, 48201

  • Novartis Investigative Site

    Durham, North Carolina, 27710

  • Novartis Investigative Site

    Fort Collins, Colorado, 80528

  • Novartis Investigative Site

    Fort Myers, Florida, 33916

  • Novartis Investigative Site

    Fresno, California, 93720

  • Novartis Investigative Site

    Hackensack, New Jersey, 07601

  • Novartis Investigative Site

    Hampton, Virginia, 23666

  • Novartis Investigative Site

    Houston, Texas, 77024

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Indianapolis, Indiana, 46202

  • Novartis Investigative Site

    Iowa City, Iowa, 52242

  • Novartis Investigative Site

    Jonesboro, Arkansas, 72401

  • Novartis Investigative Site

    La Jolla, California, 92093

  • Novartis Investigative Site

    Las Vegas, Nevada, 89169

  • Novartis Investigative Site

    Lincoln, Nebraska, 68510

  • Novartis Investigative Site

    Los Angeles, California, 90033

  • Novartis Investigative Site

    Los Angeles, California, 90048-0750

  • Novartis Investigative Site

    Los Angeles, California, 90095

  • Novartis Investigative Site

    Macon, Georgia, 31201

  • Novartis Investigative Site

    Memphis, Tennessee, 38120

  • Novartis Investigative Site

    Nashville, Tennessee, 37203

  • Novartis Investigative Site

    Nashville, Tennessee, 37232

  • Novartis Investigative Site

    New York, New York, 10003

  • Novartis Investigative Site

    New York, New York, 10021

  • Novartis Investigative Site

    New York, New York, 10065

  • Novartis Investigative Site

    Oakland, California, 94611

  • Novartis Investigative Site

    Omaha, Nebraska, 68114

  • Novartis Investigative Site

    Omaha, Nebraska, 68118

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19104

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19106

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19107

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19111

  • Novartis Investigative Site

    Portland, Oregon, 97213

  • Novartis Investigative Site

    Providence, Rhode Island, 02903

  • Novartis Investigative Site

    Providence, Rhode Island, 02906

  • Novartis Investigative Site

    Richmond, Virginia, 23230

  • Novartis Investigative Site

    Rochester, Minnesota, 55905

  • Novartis Investigative Site

    Sacramento, California, 95825

  • Novartis Investigative Site

    Saint Louis Park, Minnesota, 55416

  • Novartis Investigative Site

    San Antonio, Texas, 78217

  • Novartis Investigative Site

    San Francisco, California, 94115

  • Novartis Investigative Site

    Seattle, Washington, 98109

  • Novartis Investigative Site

    South San Francisco, California, 94080

  • Novartis Investigative Site

    Springfield, Oregon, 97477

  • Novartis Investigative Site

    St Louis, Missouri, 63110

  • Novartis Investigative Site

    Stanford, California, 94305

  • Novartis Investigative Site

    Tampa, Florida, 33612

  • Novartis Investigative Site

    Tyler, Texas, 75702

  • Novartis Investigative Site

    Vallejo, California, 94589

  • Novartis Investigative Site

    Virginia Beach, Virginia, 23462

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20007

Other trials in United States

Germany41 sites

  • Novartis Investigative Site

    Aachen, North Rhine-Westphalia, 52074

  • Novartis Investigative Site

    Bergisch Gladbach, North Rhine-Westphalia, 51465

  • Novartis Investigative Site

    Berlin, 10719

  • Novartis Investigative Site

    Berlin, 10967

  • Novartis Investigative Site

    Berlin, 12200

  • Novartis Investigative Site

    Bonn, North Rhine-Westphalia, 53127

  • Novartis Investigative Site

    Braunschweig, Lower Saxony, 38126

  • Novartis Investigative Site

    Bremen, 28177

  • Novartis Investigative Site

    Chemnitz, Saxony, 09130

  • Novartis Investigative Site

    Dessau, Saxony-Anhalt, 06846

  • Novartis Investigative Site

    Duisburg, North Rhine-Westphalia, 47179

  • Novartis Investigative Site

    Eisleben Lutherstadt, Saxony-Anhalt, 06295

  • Novartis Investigative Site

    Erlangen, Bavaria, 91054

  • Novartis Investigative Site

    Essen, North Rhine-Westphalia, 45122

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590

  • Novartis Investigative Site

    Fürth, Bavaria, 90766

  • Novartis Investigative Site

    Goslar, Lower Saxony, 38642

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30625

  • Novartis Investigative Site

    Homburg, Saarland, 66421

  • Novartis Investigative Site

    Jena, Thuringia, 07768

  • Novartis Investigative Site

    Kirchheim, Baden-Wurttemberg, 73230

  • Novartis Investigative Site

    Leipzig, Saxony, 04277

  • Novartis Investigative Site

    Lübeck, Schleswig-Holstein, 23566

  • Novartis Investigative Site

    Mainz, Rhineland-Palatinate, 55131

  • Novartis Investigative Site

    Marburg, Hesse, 35043

  • Novartis Investigative Site

    Mönchengladbach, North Rhine-Westphalia, 41063

  • Novartis Investigative Site

    Munich, Bavaria, 81675

  • Novartis Investigative Site

    Münster, North Rhine-Westphalia, 48149

  • Novartis Investigative Site

    Neuss, North Rhine-Westphalia, 41464

  • Novartis Investigative Site

    Offenbach, Hesse, 63069

  • Novartis Investigative Site

    Plauen, Saxony, 08523

  • Novartis Investigative Site

    Ravensburg, Baden-Wurttemberg, 88212

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053

  • Novartis Investigative Site

    Sigmaringen, Baden-Wurttemberg, 72488

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70174

  • Novartis Investigative Site

    Tübingen, Baden-Wurttemberg, 72076

  • Novartis Investigative Site

    Ulm, Baden-Wurttemberg, 89075

  • Novartis Investigative Site

    Velbert, North Rhine-Westphalia, 42551

  • Novartis Investigative Site

    Weiden, Bavaria, 92637

Other trials in Germany

France18 sites

  • Novartis Investigative Site

    Angers, 49055

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Bordeaux, 33075

  • Novartis Investigative Site

    Caen, 14076

  • Novartis Investigative Site

    Hyères, 83400

  • Novartis Investigative Site

    Le Mans, 72000

  • Novartis Investigative Site

    Marseille, 13385

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Paris, 75014

  • Novartis Investigative Site

    Paris, 75908

  • Novartis Investigative Site

    Poitiers, 86021

  • Novartis Investigative Site

    Reims, 51100

  • Novartis Investigative Site

    Rennes, 35042

  • Novartis Investigative Site

    Saint-Herblain, 44805

  • Novartis Investigative Site

    Strasbourg, 67085

  • Novartis Investigative Site

    Strasbourg, 67091

  • Novartis Investigative Site

    Toulouse, 31076

  • Novartis Investigative Site

    Tours, 37044

Other trials in France

Russia15 sites

  • Novartis Investigative Site

    Arkhangelsk, 163045

  • Novartis Investigative Site

    Barnaul, 656049

  • Novartis Investigative Site

    Chelyabinsk, 454087

  • Novartis Investigative Site

    Kazan', 420029

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Moscow, 117997

  • Novartis Investigative Site

    Obninsk, 249036

  • Novartis Investigative Site

    Omsk, 644013

  • Novartis Investigative Site

    Rostov-on-Don

  • Novartis Investigative Site

    Ryazan, 390011

  • Novartis Investigative Site

    Saint Petersburg, 197758

  • Novartis Investigative Site

    Saint Petersburg

  • Novartis Investigative Site

    Stavropol, 355047

  • Novartis Investigative Site

    Ufa, 450054

  • Novartis Investigative Site

    Yekaterinburg, 620102

Other trials in Russia

Canada13 sites

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4N2

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 1V7

  • Novartis Investigative Site

    Hamilton, Ontario, L8V 5C2

  • Novartis Investigative Site

    London, Ontario, N6A 4L6

  • Novartis Investigative Site

    Moncton, New Brunswick, E1C 6Z8

  • Novartis Investigative Site

    Montreal, Quebec, H2L 4M1

  • Novartis Investigative Site

    Oshawa, Ontario, L1G 2B9

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

  • Novartis Investigative Site

    Québec, Quebec, G1R 2J6

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Argentina12 sites

  • Novartis Investigative Site

    Berazategui, Buenos Aires, B1880BBF

  • Novartis Investigative Site

    Capital Federal, Buenos Aires, C1426ANZ

  • Novartis Investigative Site

    Cipolletti, Río Negro Province, R8324EMB

  • Novartis Investigative Site

    Ciudad Aut6noma de Buenos Aires, Buenos Aires, C1050AAK

  • Novartis Investigative Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1280AEB

  • Novartis Investigative Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5003DCE

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5006HBF

  • Novartis Investigative Site

    Quilmes, Buenos Aires, 1878

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000KZE

  • Novartis Investigative Site

    San Miguel de Tucumán, T4000IAK

  • Novartis Investigative Site

    Santa Fe, 3000

Other trials in Argentina

Brazil12 sites

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30130-100

  • Novartis Investigative Site

    Campinas, São Paulo, 13083-970

  • Novartis Investigative Site

    Curitiba, Paraná, 81520-060

  • Novartis Investigative Site

    Ijuí, Rio Grande do Sul, 98700-000

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610000

  • Novartis Investigative Site

    Rio de Janeiro, 20 551-030

  • Novartis Investigative Site

    Rio de Janeiro, 20231-050

  • Novartis Investigative Site

    São Paulo, São Paulo, 01246-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 01308-050

  • Novartis Investigative Site

    São Paulo, São Paulo, 05651-901

  • Novartis Investigative Site

    São Paulo, São Paulo, 08270-070

Other trials in Brazil

China12 sites

  • Novartis Investigative Site

    Beijing, 100021

  • Novartis Investigative Site

    Beijing, 100034

  • Novartis Investigative Site

    Beijing, 100191

  • Novartis Investigative Site

    Beijing, 100853

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310009

  • Novartis Investigative Site

    Shanghai, 200025

  • Novartis Investigative Site

    Shanghai, 200032

  • Novartis Investigative Site

    Shanghai, 200040

  • Novartis Investigative Site

    Shanghai, 200127

  • Novartis Investigative Site

    Tianjin, 300060

  • Novartis Investigative Site

    Wuhan, Hubei, 430030

Other trials in China

Italy12 sites

  • Novartis Investigative Site

    Arezzo, Tuscany, 52100

  • Novartis Investigative Site

    Bologna, Emilia-Romagna, 40138

  • Novartis Investigative Site

    Candiolo (TO), Piedmont, 10060

  • Novartis Investigative Site

    Meldola (FC), Emilia-Romagna, 47014

  • Novartis Investigative Site

    Milan, Lombardy, 20133

  • Novartis Investigative Site

    Modena, Emilia-Romagna, 41100

  • Novartis Investigative Site

    Naples, Campania, 80131

  • Novartis Investigative Site

    Negrar, Veneto, 37024

  • Novartis Investigative Site

    Rome, Lazio, 00144

  • Novartis Investigative Site

    Rome, Lazio, 00152

  • Novartis Investigative Site

    Rozzano (MI), Lombardy, 20089

  • Novartis Investigative Site

    Terni, Umbria, 05100

Other trials in Italy

Spain12 sites

  • Novartis Investigative Site

    Badalona, 08916

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Córdoba, 14004

  • Novartis Investigative Site

    Dos Hermanas (Sevilla), 41700

  • Novartis Investigative Site

    Madrid, 28007

  • Novartis Investigative Site

    Madrid, 28033

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Madrid, 28050

  • Novartis Investigative Site

    Málaga, 29010

  • Novartis Investigative Site

    Oviedo, 33006

  • Novartis Investigative Site

    Seville, 41013

  • Novartis Investigative Site

    Valencia, 46009

Other trials in Spain

Japan11 sites

  • Novartis Investigative Site

    Fukuoka, 812-8582

  • Novartis Investigative Site

    Hokkaido, 060-8543

  • Novartis Investigative Site

    Hokkaido, 060-8648

  • Novartis Investigative Site

    Kanagawa, 236-0004

  • Novartis Investigative Site

    Okayama, 700-8558

  • Novartis Investigative Site

    Osaka, 589-8511

  • Novartis Investigative Site

    Shizuoka, 431-3192

  • Novartis Investigative Site

    Tokyo, 113-8603

  • Novartis Investigative Site

    Tokyo, 160-8582

  • Novartis Investigative Site

    Tokyo, 162-8666

  • Novartis Investigative Site

    Yamagata, 990-9585

Other trials in Japan

Czechia10 sites

  • Novartis Investigative Site

    Brno, 656 53

  • Novartis Investigative Site

    Brno, 656 91

  • Novartis Investigative Site

    Hradec Králové, 500 05

  • Novartis Investigative Site

    Nový Jičín, 741 01

  • Novartis Investigative Site

    Olomouc, 775 20

  • Novartis Investigative Site

    Ostrava - Poruba, 708 52

  • Novartis Investigative Site

    Pilsen, 304 60

  • Novartis Investigative Site

    Prague, 12808

  • Novartis Investigative Site

    Prague, 180 00

  • Novartis Investigative Site

    Ústí nad Labem, 40113

Other trials in Czechia

Poland9 sites

  • Novartis Investigative Site

    Gdansk, 80-219

  • Novartis Investigative Site

    Konin, 62-500

  • Novartis Investigative Site

    Krakow, 31-108

  • Novartis Investigative Site

    Krakow, 31-115

  • Novartis Investigative Site

    Lublin, 20-090

  • Novartis Investigative Site

    Warsaw, 02-776

  • Novartis Investigative Site

    Warsaw, 02-781

  • Novartis Investigative Site

    Warsaw, 04-125

  • Novartis Investigative Site

    Wroclaw, 50-556

Other trials in Poland

South Korea9 sites

  • Novartis Investigative Site

    Daejeon, 35015

  • Novartis Investigative Site

    Goyang-si, Gyeonggi-do, 410-769

  • Novartis Investigative Site

    Jeonju, 54907

  • Novartis Investigative Site

    Seongnam-si Gyeonggi-do, 13620

  • Novartis Investigative Site

    Seoul, 03080

  • Novartis Investigative Site

    Seoul, 06351

  • Novartis Investigative Site

    Seoul, 120-752

  • Novartis Investigative Site

    Seoul, 136-705

  • Novartis Investigative Site

    Songpa-gu, Seoul, 138-736

Other trials in South Korea

United Kingdom9 sites

  • Novartis Investigative Site

    Brighton, BN2 5BE

  • Novartis Investigative Site

    Cornwall, TR1 3LJ

  • Novartis Investigative Site

    Guildford, GU2 7XX

  • Novartis Investigative Site

    London, NW3 2QG

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    Manchester, M20 4BX

  • Novartis Investigative Site

    Preston, PR2 9HT

  • Novartis Investigative Site

    Swansea, SA2 8QA

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Austria6 sites

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Innsbruck, 6020

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Salzburg, A-5020

  • Novartis Investigative Site

    Vienna, 1130

  • Novartis Investigative Site

    Vienna, A-1090

Other trials in Austria

Belgium6 sites

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Jette, 1090

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Namur, 5000

  • Novartis Investigative Site

    Roeselare, 8800

  • Novartis Investigative Site

    Wilrijk, 2610

Other trials in Belgium

Hungary6 sites

  • Novartis Investigative Site

    Budapest, 1082

  • Novartis Investigative Site

    Budapest, 1097

  • Novartis Investigative Site

    Budapest, 1122

  • Novartis Investigative Site

    Miskolc, 3526

  • Novartis Investigative Site

    Nyíregyháza, 4400

  • Novartis Investigative Site

    Szombathely, 9700

Other trials in Hungary

Israel6 sites

  • Novartis Investigative Site

    Haifa, 31096

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Rehovot, 76100

  • Novartis Investigative Site

    Tel Aviv, 64239

  • Novartis Investigative Site

    Zrifin, 70300

Other trials in Israel

Ireland5 sites

  • Novartis Investigative Site

    Cork

  • Novartis Investigative Site

    Dublin, 7

  • Novartis Investigative Site

    Dublin, 9

  • Novartis Investigative Site

    Galway

  • Novartis Investigative Site

    Tallaght, Dublin, 24

Other trials in Ireland

Slovakia5 sites

  • Novartis Investigative Site

    Banská Bystrica, 975 17

  • Novartis Investigative Site

    Bratislava, 833 05

  • Novartis Investigative Site

    Košice, 041 66

  • Novartis Investigative Site

    Martin, 036 59

  • Novartis Investigative Site

    Žilina, 012 07

Other trials in Slovakia

Greece4 sites

  • Novartis Investigative Site

    Athens, 115 22

  • Novartis Investigative Site

    Heraklion, Crete, 71100

  • Novartis Investigative Site

    Pátrai, 26504

  • Novartis Investigative Site

    Thessaloniki

Other trials in Greece

Turkey (Türkiye)4 sites

  • Novartis Investigative Site

    Ankara, 06100

  • Novartis Investigative Site

    Ankara, 06590

  • Novartis Investigative Site

    Istanbul, 34390

  • Novartis Investigative Site

    Izmir, 35100

Other trials in Turkey (Türkiye)

Denmark3 sites

  • Novartis Investigative Site

    Aarhus, 8000 Aarhus C

  • Novartis Investigative Site

    Dk-2730 Herlev, 2730

  • Novartis Investigative Site

    Odense C, 5000

Other trials in Denmark

Chile2 sites

  • Novartis Investigative Site

    Santiago, Región Metro de Santiago, 7500921

  • Novartis Investigative Site

    Viña del Mar, Valparaiso, 254-0364

Other trials in Chile

Luxembourg1 site

  • Novartis Investigative Site

    Luxembourg, 1210

Other trials in Luxembourg

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
pazopanib, placebo
Keywords
anti-angiogenic agent, renal cell carcinoma, pazopanib, adjuvant therapy, VEGFR inhibitor, localized or locally, advanced renal cell carcinoma (RCC) following nephrectomy, advanced RCC, Cancer
Medical subject headings
Carcinoma, Renal Cell, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pazopanibDrug

    Also called PZP034

    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.

  • placeboDrug

    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.

  • pazopanibDrug

    Also called Votrient

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

  • placeboDrug

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

Study groups in NCT01235962
Study groupRoleWhat they receive
pazopanibExperimentalPazopanib 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.
Receives: Drug: pazopanib
placeboPlacebo 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.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: approximately 5 years

Secondary outcomes (19)

  1. Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo

    Overall survival is defined as the time from randomization until death due to any cause.

    For subjects who did not die, time to death was censored at the last date of known contact.

    Measured: approximately 8.5 years

  2. DFS Rates at Yearly Time Points With Pazopanib 600 mg Daily Initial Dose vs. Placebo

    Measured: yearly for 4 years

  3. DFS With Pazopanib 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.

    Measured: approximately 5 years

  4. OS With Pazopanib vs. Placebo

    Overall survival is defined as the time from randomization until death due to any cause.

    For subjects who do not die, time to death will be censored at the last date of known contact.

    Measured: approximately 8.5 years

  5. DFS Rates at Yearly Time Points With Pazopanib vs. Placebo

    Measured: yearly for 4 years

  6. DFS Pazopanib 800 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.

    Measured: approximately 5 years

  7. OS With Pazopanib 800 mg Daily Initial Dose vs. Placebo

    Overall survival is defined as the time from randomization until death due to any cause.

    For subjects who did not die, time to death was censored at the last date of known contact.

    Measured: approximately 8.5 years

  8. Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/Functional Assessment of Cancer Therapy-Kidney Symptom Index -19 (FACT FKSI-19) Total Score

    Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (FKSI-DRS-P, FKSI-DRS-E, FKSI-TSE, FKSI-FWB) experienced in the past 7 days. Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). A negative mean indicates a worsening of condition. DFS: disease-free survival; FU: follow up

    Measured: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

  9. Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score

    Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). A negative mean indicates a worsening of condition.

    Measured: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

  10. Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease Related Symptoms-emotional (DRS-E) Domain Score

    Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative mean indicates a worsening of condition.

    Measured: Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU

  11. Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score

    Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

    Measured: Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU

  12. Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score

    Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

    Measured: Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU

  13. Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score

    Health outcome and quality of life measured by EQ-5D thermometer (thermo) score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

  14. Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Total Score

    Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (FKSI-DRS-P, FKSI-DRS-E, FKSI-TSE, FKSI-FWB) experienced in the past 7 days. Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). A negative mean indicates a worsening of condition. DFS: disease-free survival; FU: follow up

    Measured: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

  15. Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score

    Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). A negative mean indicates a worsening of condition.

    Measured: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

  16. Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-emotional (DRS-E) Domain Score

    Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4).A negative mean indicates a worsening of condition.

    Measured: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

  17. Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score

    Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

    Measured: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

  18. Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score

    Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.

    Measured: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

  19. Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score

    Health outcome and quality of life measured by using EQ-5D thermometer score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2010 (estimated)
  2. Study start30 Nov 2010
  3. Primary completion15 Oct 2015
  4. Study completion15 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,538 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01235962
Sponsor's protocol ID
113387
Other IDs
2010-020965-26, CPZP034D2301
Acronym
PROTECT
Status last verified
Oct 2020
First submitted
14 Oct 2010
Last updated
23 Nov 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 20100962

  • 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.

    PubMed 33461782

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pazopanib in people with Renal Cell Carcinoma (RCC) and Cancer, run by Novartis Pharmaceuticals at 312 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 312 sites in United States, Germany, France, Russia, Canada and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo (time frame: approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01235962, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.

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