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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Renal Cell
• Intervention / Treatment: Drug: Pazopanib; Drug: Sunitinib

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.

• Study Type: Interventional
• Enrollment (Actual): 1110
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sunitinib; Control arm	Drug: Sunitinib; 50 mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment
Experimental: Pazopanib; Experimental arm	Drug: Pazopanib; 800 mg administered once daily orally continuous dosing; Other Names: GW786034

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival was defined as the time from randomization until death due to any cause.	From randomization until date of death from any cause, assessed up to approximately 62 months
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.	From randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months
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.	From randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months
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.	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
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.	From study treatment start date till 28 days safety follow-up, assessed up to approximately 152 months
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.	Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
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.	Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
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.	Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
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.	Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
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.	Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
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.	Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
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.	Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
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.	Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
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.	Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
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.	Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
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.	From Day 1 up to Week 24
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.	Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Collected Deaths	Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication. On-treatment deaths were collected from first dose of study medication to 28 days after last dose of study medication (on-treatment), up to approximately 129 months. Deaths were collected in the post treatment survival follow up from 29 days after last dose of study medication until the end of the study, up to approximately 152 months.	Pre-treatment deaths: Up to 21 days prior to treatment. On-treatment deaths: Up to 129 months. Post-treatment deaths: up to 152 months.

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2008
• Primary Completion (Actual): May 21, 2012
• Study Completion (Actual): March 24, 2021

Study Registration Dates

• First Submitted: July 22, 2008
• First Submitted That Met QC Criteria: July 22, 2008
• First Posted (Estimated): July 23, 2008

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Renal cell carcinoma; Pazopanib; GW786034; Sunitinib; SUTENT; Locally advanced and/or metastatic renal cell carcinoma
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Kidney Neoplasms; Carcinoma; Carcinoma, Renal Cell; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Sunitinib
• Other Study ID Numbers: 108844; 2008-002102-19 (EudraCT Number); CPZP034A2301 (Other Identifier: Novartis); VEG108844 (Other Identifier: GlaxoSmithKline)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No