AzTrials
AzTrials

Carcinoma, Renal CellPhase 3COMPARZNCT00720941

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

A Phase 3 study testing Pazopanib and Sunitinib in people with Carcinoma, Renal Cell, run by Novartis Pharmaceuticals at 227 sites in 14 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 was a randomized, open-label, parallel group Phase III non inferiority study to evaluate the efficacy and safety of pazopanib compared with sunitinib in subjects with advanced renal cell carcinoma (RCC) who had not received prior systemic therapy for advanced or metastatic RCC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Pazopanib and Sunitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,110 participants
Where
227 sitesin 14 countries
Study dates
14 Aug 2008to 24 Mar 2021
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

  • Written informed consent
  • Diagnosis of renal cell carcinoma with clear-cell component histology.
  • Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC
  • Locally advanced or metastatic renal cell carcinoma
  • Measurable disease by CT or MRI
  • Karnofsky performance scale status of >=70
Show all 11Show fewer
  • Age >=18 years
  • A female is eligible to enter and participate in this study if she is of: non-childbearing or agrees to use adequate contraception.
  • Adequate organ system function
  • Total serum calcium concentration <12.0mg/dL
  • Left ventricular ejection fraction >= lower limit of institutional normal.

Who cannot join

  • Pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study)
  • History of another malignancy (unless have been disease-free for 3 years)
  • History or clinical evidence of central nervous system (CNS) metastases (unless have previously-treated CNS metastases and meet all 3 of the following criteria are: are asymptomatic, have had no evidence of active CNS metastases for >=6 months prior to enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants)
  • Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, known intraluminal metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
  • Presence of uncontrolled infection.
  • Prolongation of corrected QT interval (QTc) > 480 milliseconds
Show all 21Show fewer
  • History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association
  • History of cerebrovascular accident including transient ischemic attack within the past 12 months
  • History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless had recent DVT and have been treated with therapeutic anti-coagulating agents for at least 6 weeks)
  • Poorly controlled hypertension (defined as systolic blood pressure of >=150mmHg or diastolic blood pressure of >=90mmHg). Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry
  • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
  • Evidence of active bleeding or bleeding susceptibility
  • Spitting/coughing up blood within 6 weeks of first dose of study drug
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
  • Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study.
  • Use any prohibited medications within 14 days of the first dose of study medication.
  • Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
  • Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafenib, etc), or are mTOR inhibitors (eg. temsirolimus, everolimus, etc).
  • Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy)
  • Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or sunitinib.

Trial locations and contacts

227 sites in 14 countries.

227 sites in 14 countries

United States96 sites

  • Novartis Investigative Site

    Annapolis, Maryland, 21401

  • Novartis Investigative Site

    Arlington, Texas, 76012

  • Novartis Investigative Site

    Atlanta, Georgia, 30318

  • 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, 14215

  • Novartis Investigative Site

    Carmel, Indiana, 46032

  • Novartis Investigative Site

    Cedar Rapids, Iowa, 52403

  • Novartis Investigative Site

    Charleston, South Carolina, 29403

  • Novartis Investigative Site

    Charleston, South Carolina, 29425

  • Novartis Investigative Site

    Charlottesville, Virginia, 22903

  • Novartis Investigative Site

    Chattanooga, Tennessee, 37404

  • Novartis Investigative Site

    Chicago, Illinois, 60612

  • Novartis Investigative Site

    Cincinnati, Ohio, 45242

  • Novartis Investigative Site

    Cleveland, Ohio, 44106

  • Novartis Investigative Site

    Columbus, Ohio, 43210

  • Novartis Investigative Site

    Columbus, Ohio, 43219

  • Novartis Investigative Site

    Corpus Christi, Texas, 78463-3069

  • Novartis Investigative Site

    Dallas, Texas, 75246

  • Novartis Investigative Site

    Dayton, Ohio, 45429

  • Novartis Investigative Site

    Denver, Colorado, 80218

  • Novartis Investigative Site

    Detroit, Michigan, 48201

  • Novartis Investigative Site

    Duluth, Minnesota, 55805

  • Novartis Investigative Site

    Elk Grove Village, Illinois, 60007

  • Novartis Investigative Site

    Escondido, California, 92025

  • Novartis Investigative Site

    Eugene, Oregon, 97401

  • Novartis Investigative Site

    Fort Myers, Florida, 33916

  • Novartis Investigative Site

    Fort Worth, Texas, 76104

  • Novartis Investigative Site

    Fresno, California, 93720

  • Novartis Investigative Site

    Greenbrae, California, 94904-2007

  • Novartis Investigative Site

    Greenville, South Carolina, 29605

  • Novartis Investigative Site

    Hackensack, New Jersey, 07601

  • Novartis Investigative Site

    Hampton, Virginia, 23666

  • Novartis Investigative Site

    Hayward, California, 94545

  • Novartis Investigative Site

    Hickory, North Carolina, 28602

  • Novartis Investigative Site

    Huntsville, Alabama, 35805

  • Novartis Investigative Site

    Indianapolis, Indiana, 46202

  • Novartis Investigative Site

    Indianapolis, Indiana, 46237

  • Novartis Investigative Site

    Kansas City, Missouri, 64118

  • Novartis Investigative Site

    Kansas City, Missouri, 64131

  • Novartis Investigative Site

    La Jolla, California, 92037

  • Novartis Investigative Site

    Las Vegas, Nevada, 89135

  • Novartis Investigative Site

    Las Vegas, Nevada, 89169

  • Novartis Investigative Site

    Lebanon, New Hampshire, 03756

  • Novartis Investigative Site

    Lincoln, Nebraska, 68510

  • Novartis Investigative Site

    Little Rock, Arkansas, 72205

  • Novartis Investigative Site

    Los Angeles, California, 90095

  • Novartis Investigative Site

    Louisville, Kentucky, 40202

  • Novartis Investigative Site

    Lubbock, Texas, 79410

  • Novartis Investigative Site

    Maywood, Illinois, 60153

  • Novartis Investigative Site

    Miami, Florida, 33136

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55455

  • Novartis Investigative Site

    Montebello, California, 90640

  • Novartis Investigative Site

    Mt. Pleasant, South Carolina, 29464

  • Novartis Investigative Site

    Nashville, Tennessee, 37203

  • Novartis Investigative Site

    New York, New York, 10032

  • Novartis Investigative Site

    New York, New York, 10065

  • Novartis Investigative Site

    Oakland, California, 94611

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73120

  • Novartis Investigative Site

    Orange, California, 92868

  • Novartis Investigative Site

    Orlando, Florida, 32806

  • Novartis Investigative Site

    Paducah, Kentucky, 42003

  • Novartis Investigative Site

    Peoria, Illinois, 61615-7822

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19102

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19111

  • Novartis Investigative Site

    Portland, Oregon, 97213

  • Novartis Investigative Site

    Raleigh, North Carolina, 27607

  • Novartis Investigative Site

    Richmond, Virginia, 23230

  • Novartis Investigative Site

    Roseville, California, 95661

  • Novartis Investigative Site

    Round Rock, Texas, 78681

  • Novartis Investigative Site

    Sacramento, California, 95817

  • Novartis Investigative Site

    Sacramento, California, 95825

  • Novartis Investigative Site

    Salem, Virginia, 24153

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    San Bernardino, California, 92404

  • Novartis Investigative Site

    San Francisco, California, 94115

  • Novartis Investigative Site

    San Jose, California, 95119-1110

  • Novartis Investigative Site

    Santa Clara, California, 95051

  • Novartis Investigative Site

    Seattle, Washington, 98101

  • Novartis Investigative Site

    Seattle, Washington, 98109

  • Novartis Investigative Site

    South San Francisco, California, 94080

  • Novartis Investigative Site

    Southington, Connecticut, 06489

  • Novartis Investigative Site

    Trumbull, Connecticut, 06611

  • Novartis Investigative Site

    Tucson, Arizona, 85710

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74136

  • Novartis Investigative Site

    Tupelo, Mississippi, 38801

  • Novartis Investigative Site

    Tyler, Texas, 75702

  • Novartis Investigative Site

    Vallejo, California, 94589

  • Novartis Investigative Site

    Walnut Creek, California, 94596

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20007

  • Novartis Investigative Site

    Webster, Texas, 77598-4420

  • Novartis Investigative Site

    Wichita Falls, Texas, 76310

  • Novartis Investigative Site

    Worcester, Massachusetts, 01608

Other trials in United States

Germany22 sites

  • Novartis Investigative Site

    Aachen, North Rhine-Westphalia, 52074

  • Novartis Investigative Site

    Berlin, 10117

  • Novartis Investigative Site

    Berlin, 10719

  • Novartis Investigative Site

    Bonn, North Rhine-Westphalia, 53127

  • Novartis Investigative Site

    Dortmund, North Rhine-Westphalia, 44145

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Duisburg, North Rhine-Westphalia, 47053

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Novartis Investigative Site

    Eisleben Lutherstadt, Saxony-Anhalt, 06295

  • Novartis Investigative Site

    Essen, North Rhine-Westphalia, 45122

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30171

  • Novartis Investigative Site

    Homburg, Saarland, 66421

  • Novartis Investigative Site

    Kirchheim, Baden-Wurttemberg, 73230

  • Novartis Investigative Site

    Leipzig, Saxony, 04103

  • Novartis Investigative Site

    Magdeburg, Saxony-Anhalt, 39104

  • Novartis Investigative Site

    Marburg, Hesse, 35043

  • Novartis Investigative Site

    Munich, Bavaria, 81377

  • Novartis Investigative Site

    Offenbach, Hesse, 63069

  • Novartis Investigative Site

    Planegg, Bavaria, 82152

  • Novartis Investigative Site

    Plauen, Saxony, 08523

  • Novartis Investigative Site

    Sigmaringen, Baden-Wurttemberg, 72488

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70174

Other trials in Germany

Japan20 sites

  • Novartis Investigative Site

    Ehime, 791-0280

  • Novartis Investigative Site

    Fukuoka, 812-0033

  • Novartis Investigative Site

    Fukuoka, 812-8582

  • Novartis Investigative Site

    Hokkaido, 060-8543

  • Novartis Investigative Site

    Hokkaido, 060-8648

  • Novartis Investigative Site

    Ibaraki, 305-8576

  • Novartis Investigative Site

    Kanagawa, 236-0004

  • Novartis Investigative Site

    Kyoto, 606-8507

  • Novartis Investigative Site

    Numakunai, 020-8505

  • Novartis Investigative Site

    Okayama, 700-8558

  • Novartis Investigative Site

    Osaka, 565-0871

  • Novartis Investigative Site

    Osaka, 589-8511

  • Novartis Investigative Site

    Shizuoka, 431-3192

  • Novartis Investigative Site

    Tokyo, 104-0045

  • Novartis Investigative Site

    Tokyo, 113-8655

  • Novartis Investigative Site

    Tokyo, 135-8550

  • Novartis Investigative Site

    Tokyo, 160-8582

  • Novartis Investigative Site

    Tokyo, 162-8666

  • Novartis Investigative Site

    Tokyo, 173-8606

  • Novartis Investigative Site

    Yamagata, 990-9585

Other trials in Japan

United Kingdom15 sites

  • Novartis Investigative Site

    Bebington, Wirral, CH63 4JY

  • Novartis Investigative Site

    Birmingham, B15 2TH

  • Novartis Investigative Site

    Bristol, Gloucestershire, BS2 8ED

  • Novartis Investigative Site

    Cambridge, CB2 0QQ

  • Novartis Investigative Site

    Glasgow, G12 OYN

  • Novartis Investigative Site

    Leeds, LS9 7TF

  • Novartis Investigative Site

    London, EC1A 7BE

  • Novartis Investigative Site

    London, NW3 2QG

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    London, SW3 6JJ

  • Novartis Investigative Site

    Manchester, M20 4BX

  • Novartis Investigative Site

    Northwood, Middlesex, HA6 2RN

  • Novartis Investigative Site

    Nottingham, NG5 1PB

  • Novartis Investigative Site

    Sheffield, S10 2SJ

  • Novartis Investigative Site

    Swansea, SA2 8QA

Other trials in United Kingdom

Canada12 sites

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4N2

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2

  • 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

    Montreal, Quebec, H3T 1E2

  • Novartis Investigative Site

    Oshawa, Ontario, L1G 2B9

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia9 sites

  • Novartis Investigative Site

    Bedford Park, South Australia, 5042

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050

  • Novartis Investigative Site

    Heidelberg, Victoria, 3084

  • Novartis Investigative Site

    Hobart, Tasmania, 7000

  • Novartis Investigative Site

    Kogarah, New South Wales, 2217

  • Novartis Investigative Site

    Randwick, New South Wales, 2031

  • Novartis Investigative Site

    Waratah, New South Wales, 2298

  • Novartis Investigative Site

    Westmead, New South Wales, 2145

  • Novartis Investigative Site

    Wodonga, Victoria, 3690

Other trials in Australia

China9 sites

  • Novartis Investigative Site

    Beijing, 100021

  • Novartis Investigative Site

    Beijing, 100034

  • Novartis Investigative Site

    Beijing, 100036

  • Novartis Investigative Site

    Beijing, 100853

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510060

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210002

  • Novartis Investigative Site

    Shanghai, 200032

  • Novartis Investigative Site

    Shanghai, 200127

  • Novartis Investigative Site

    Tianjin, 300060

Other trials in China

Netherlands8 sites

  • Novartis Investigative Site

    Alkmaar, 1815 JD

  • Novartis Investigative Site

    Amsterdam, 1066 CX

  • Novartis Investigative Site

    Breda, 4819 EV

  • Novartis Investigative Site

    Groningen, 9713 GZ

  • Novartis Investigative Site

    Sittard-geleen, 6162 BG

  • Novartis Investigative Site

    The Hague, 2545CH

  • Novartis Investigative Site

    Tilburg, 5022 GC

  • Novartis Investigative Site

    Utrecht, 3584 CX

Other trials in Netherlands

Spain8 sites

  • Novartis Investigative Site

    Badalona, 08916

  • Novartis Investigative Site

    Barakaldo (Vizcaya), 48903

  • Novartis Investigative Site

    Barcelona, 08036

  • Novartis Investigative Site

    Girona, 17007

  • Novartis Investigative Site

    Madrid, 28033

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Pamplona, 31008

Other trials in Spain

Italy7 sites

  • Novartis Investigative Site

    Arezzo, Tuscany, 52100

  • Novartis Investigative Site

    Meldola (FC), Emilia-Romagna, 47014

  • Novartis Investigative Site

    Milan, Lombardy, 20141

  • Novartis Investigative Site

    Naples, Campania, 80131

  • Novartis Investigative Site

    Pordenone, Friuli Venezia Giulia, 33170

  • Novartis Investigative Site

    Ravenna, Emilia-Romagna, 48100

  • Novartis Investigative Site

    Rome, Lazio, 00152

Other trials in Italy

South Korea7 sites

  • Novartis Investigative Site

    Daegu, 700-721

  • Novartis Investigative Site

    Daejeon, 301-721

  • Novartis Investigative Site

    Goyang-si, Gyeonggi-Do, 410-769

  • Novartis Investigative Site

    Seoul, 110-744

  • Novartis Investigative Site

    Seoul, 120-752

  • Novartis Investigative Site

    Seoul, 135-710

  • Novartis Investigative Site

    Seoul, 138-736

Other trials in South Korea

Taiwan6 sites

  • Novartis Investigative Site

    Kaohsiung Hsien, 833

  • Novartis Investigative Site

    Taichung, 40402

  • Novartis Investigative Site

    Taichung, 40705

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taipei, 11217

  • Novartis Investigative Site

    Taoyuan, 333

Other trials in Taiwan

Ireland5 sites

  • Novartis Investigative Site

    Dublin, 7

  • Novartis Investigative Site

    Dublin, 8

  • Novartis Investigative Site

    Dublin, 9

  • Novartis Investigative Site

    Galway

  • Novartis Investigative Site

    Tallaght, Dublin, 24

Other trials in Ireland

Sweden3 sites

  • Novartis Investigative Site

    Lund, SE-221 85

  • Novartis Investigative Site

    Stockholm, SE-171 76

  • Novartis Investigative Site

    Uppsala, SE-751 85

Other trials in Sweden

About this study

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

This was a randomized, open-label, parallel group Phase III non inferiority study to evaluate the efficacy and safety of pazopanib compared with sunitinib in subjects with advanced renal cell carcinoma (RCC) who had not received prior systemic therapy for advanced or metastatic RCC.

Read the detailed description

Approximately 876 eligible subjects (approximately 438 per treatment arm) were planned to be enrolled over the course of the study. However, due to higher than expected withdrawal rates and discordance rates between independent review committee (IRC) and investigator assessments of progression, the protocol was amended (Protocol Amendment 4) to increase the number of subjects to approximately 1100 total by including all subjects enrolled in CPZP034A2301 (hereafter referred as Study A2301) and CPZP034A2201 (a sub study of CPZP034A2301, hereafter referred as Study A2201 with NCT01147822).

The subjects were centrally randomized in 1:1 ratio to receive either 800mg pazopanib to be administered once daily orally continuous dosing or 50mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment. Subjects were permitted to receive supportive care throughout the study including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoietin, or bisphosphonates, when appropriate. The study treatment continued until subjects experience disease progression, unacceptable toxicity, withdraw consent, or death.

Being tested
Pazopanib, Sunitinib
Keywords
SUTENT, Locally advanced and/or metastatic renal cell carcinoma, Pazopanib, Sunitinib, GW786034, Renal cell carcinoma
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • PazopanibDrug

    Also called GW786034

    800 mg administered once daily orally continuous dosing

  • SunitinibDrug

    50 mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment

Study groups in NCT00720941
Study groupRoleWhat they receive
SunitinibActive comparatorControl arm
Receives: Drug: Sunitinib
PazopanibExperimentalExperimental arm
Receives: Drug: Pazopanib

What is being measured

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

  1. Progression-free Survival (PFS)

    PFS was defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion.

    Measured: From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months

Secondary outcomes (17)

  1. Overall Survival

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

    Measured: From randomization until date of death from any cause, assessed up to approximately 62 months

  2. Overall Response Rate (ORR) as Assessed by Independent Review

    The number of participants with evidence of Complete Response (CR) (the disappearance of all target and non-target lesions), Partial Response (PR) (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD), Stable Disease (small changes that do not meet previously given criteria, taking as reference the smallest sum LD since the treatment started), or Progressive Disease (a >=20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started) was evaluated by an independent review per RECIST, Version 1.

    Measured: From randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months

  3. Time to Response

    Time to response was defined as the time from the start of treatment until the first documented evidence of CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.

    Measured: From randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months

  4. Duration of Response (DOR)

    DOR was defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.

    Measured: From the date of the first documented response (CR or PR) to the date of first documented progression or death due to any cause, assessed up to approximately 39 months

  5. Number of Participants With Adverse Events

    The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs), through the monitoring of relevant clinical and laboratory safety parameters.

    Measured: From study treatment start date till 28 days safety follow-up, assessed up to approximately 152 months

  6. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4

    FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level.

    Measured: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

  7. Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4

    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 (Disease-Related Symptoms - Physical (FKSI-DRS-P), Disease-Related Symptoms - Emotional (FKSI-DRS-E), Treatment Side-Effects (FKSI-TSE), Function/Well-Being (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.

    Measured: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

  8. Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4

    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 (Disease-Related Symptoms - Physical (FKSI-DRS-P), Disease-Related Symptoms - Emotional (FKSI-DRS-E), Treatment Side-Effects (FKSI-TSE), Function/Well-Being (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.

    Measured: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

  9. Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4

    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 (Disease-Related Symptoms - Physical (FKSI-DRS-P), Disease-Related Symptoms - Emotional (FKSI-DRS-E), Treatment Side-Effects (FKSI-TSE), Function/Well-Being (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.

    Measured: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

  10. Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4

    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 (Disease-Related Symptoms - Physical (FKSI-DRS-P), Disease-Related Symptoms - Emotional (FKSI-DRS-E), Treatment Side-Effects (FKSI-TSE), Function/Well-Being (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.

    Measured: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

  11. Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4

    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 (Disease-Related Symptoms - Physical (FKSI-DRS-P), Disease-Related Symptoms - Emotional (FKSI-DRS-E), Treatment Side-Effects (FKSI-TSE), Function/Well-Being (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.

    Measured: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

  12. Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4

    The SQLQ scale consists of 5 items that assess the worst mouth and throat, hand, and foot soreness, as well as limitations due to mouth/throat and foot soreness. Participants were asked to assess their worst mouth/throat, hand, and foot soreness by answering the question of " In the past 4 weeks, what was your worst mouth/throat, hand, and foot soreness?" by using the following 4-point scale: 0, I never had any soreness; 1, I had a little bit of soreness; 2, I had quite a lot of soreness; 3, I had severe soreness. A positive mean change from Baseline represents a worsening of condition.

    Measured: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

  13. Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4

    The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Participants assessed the limitations caused by their mouth/throat soreness by answering the question of "In the past 4 weeks, how much did your worst mouth/throat soreness limit you in the following activities: swallowing/eating/drinking/talking/sleeping" by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from "3" for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition.

    Measured: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

  14. Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4

    The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Participants assessed the limitations caused by their foot soreness by answering the question of "In the past 4 weeks, how much did your worst foot soreness limit you in each of the following activities: standing/walking/climbing stairs/sleeping/ability to do usual activities" by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from "3" for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition.

    Measured: Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

  15. Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4

    The CTSQ assesses 3 domains related to the participant's satisfaction with cancer therapy: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Participants shared their thoughts on their cancer therapy (9 questions), their satisfaction with their most recently administered cancer therapy (6 questions), and if they would take the same cancer therapy if given the choice to do so again. All questions were assessed on a 5-point scale; 1, never; 5, always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better treatment satisfaction.

    Measured: Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

  16. Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24

    Non-study medical visits were defined as the sum of primary care physician visits, nurse practitioner/physician's assistant/nurse visits, and medical or surgical specialist visits. Days hospitalized were defined as the sum of days in the general ward and days in intensive care. The number of telephone consultations and ER visits was assessed via individual questions on the electronic Case Report Form. The endpoint was totaled through Week 24, divided by the number of days on treatment for each participant, then multiplied by 30 days to get the number of visits per 30 days.

    Measured: From Day 1 up to Week 24

  17. Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures at Day 28 of Cycles 1-4

    The number of non-study laboratory visits (NSLVs), non-study radiology visits (NSRVs), and home healthcare visits (HHVs) were each collected as a single question on the eCRF. The number of non-study medical or surgical procedures (MSPs) was defined as the sum of procedures performed at outpatient or physician clinics, as well as those performed during any inpatient hospitalization.

    Measured: Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

Timeline

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

  1. First posted23 Jul 2008 (estimated)
  2. Study start14 Aug 2008
  3. Primary completion21 May 2012
  4. Study completion24 Mar 2021

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
None (open label)
Enrolment
1,110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00720941
Sponsor's protocol ID
108844
Other IDs
2008-002102-19, CPZP034A2301, VEG108844, 2008
Acronym
COMPARZ
Status last verified
Mar 2025
First submitted
22 Jul 2008
Last updated
30 Mar 2025
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

  • Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

    PubMed 37146227

  • Sheng X, Jin J, He Z, Huang Y, Zhou A, Wang J, Ren X, Ye D, Zhang X, Qin S, Zhou F, Wang B, Guo J. Pazopanib versus sunitinib in Chinese patients with locally advanced or metastatic renal cell carcinoma: pooled subgroup analysis from the randomized, COMPARZ studies. BMC Cancer. 2020 Mar 14;20(1):219. doi: 10.1186/s12885-020-6708-8.

    PubMed 32171288

  • Sternberg CN, Motzer RJ, Hutson TE, Choueiri TK, Kollmannsberger C, Bjarnason GA, Paul Nathan, Porta C, Grunwald V, Dezzani L, Han J, Tannir NM. COMPARZ Post Hoc Analysis: Characterizing Pazopanib Responders With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2019 Dec;17(6):425-435.e4. doi: 10.1016/j.clgc.2019.01.015. Epub 2019 Feb 6.

    PubMed 31601514

  • Guo J, Jin J, Oya M, Uemura H, Takahashi S, Tatsugami K, Rha SY, Lee JL, Chung J, Lim HY, Wu HC, Chang YH, Azad A, Davis ID, Carrasco-Alfonso MJ, Nanua B, Han J, Ahmad Q, Motzer R. Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial. J Hematol Oncol. 2018 May 22;11(1):69. doi: 10.1186/s13045-018-0617-1.

    PubMed 29788981

  • Grunwald V, Dietrich M, Pond GR. Early tumor shrinkage is independently associated with improved overall survival among patients with metastatic renal cell carcinoma: a validation study using the COMPARZ cohort. World J Urol. 2018 Sep;36(9):1423-1429. doi: 10.1007/s00345-018-2297-4. Epub 2018 Apr 13.

    PubMed 29654533

  • Beaumont JL, Salsman JM, Diaz J, Deen KC, McCann L, Powles T, Hackshaw MD, Motzer RJ, Cella D. Quality-adjusted time without symptoms or toxicity analysis of pazopanib versus sunitinib in patients with renal cell carcinoma. Cancer. 2016 Apr 1;122(7):1108-15. doi: 10.1002/cncr.29888. Epub 2016 Jan 27.

    PubMed 27000445

  • Goldstein D, Rosenberg JE, Figlin RA, Townsend RR, McCann L, Carpenter C, Pandite L. Is change in blood pressure a biomarker of pazopanib and sunitinib efficacy in advanced/metastatic renal cell carcinoma? Eur J Cancer. 2016 Jan;53:96-104. doi: 10.1016/j.ejca.2015.10.006. Epub 2015 Dec 15.

    PubMed 26702763

  • Sorich MJ, Kichenadasse G, Rowland A, Woodman RJ, Mangoni AA. Angiotensin system inhibitors and survival in patients with metastatic renal cell carcinoma treated with VEGF-targeted therapy: A pooled secondary analysis of clinical trials. Int J Cancer. 2016 May 1;138(9):2293-9. doi: 10.1002/ijc.29972. Epub 2016 Jan 6.

    PubMed 26685869

  • Lai JS, Beaumont JL, Diaz J, Khan S, Cella D. Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma. Cancer. 2016 Jan 15;122(2):287-95. doi: 10.1002/cncr.29655. Epub 2015 Oct 12.

    PubMed 26457466

  • Motzer RJ, Hutson TE, Cella D, Reeves J, Hawkins R, Guo J, Nathan P, Staehler M, de Souza P, Merchan JR, Boleti E, Fife K, Jin J, Jones R, Uemura H, De Giorgi U, Harmenberg U, Wang J, Sternberg CN, Deen K, McCann L, Hackshaw MD, Crescenzo R, Pandite LN, Choueiri TK. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med. 2013 Aug 22;369(8):722-31. doi: 10.1056/NEJMoa1303989.

    PubMed 23964934

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pazopanib and Sunitinib in people with Carcinoma, Renal Cell, run by Novartis Pharmaceuticals at 227 sites in 14 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 11 inclusion and 21 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 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 sites in United States, Germany, Japan, United Kingdom, Canada and 9 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. 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 17 Jun 2013). 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?

Progression-free Survival (PFS) (time frame: From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months). 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 NCT00720941, which also lists 10 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 30 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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