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
4 other identifiers
interventional
1,110
14 countries
227
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2008
Longer than P75 for phase_3
227 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2008
CompletedFirst Posted
Study publicly available on registry
July 23, 2008
CompletedStudy Start
First participant enrolled
August 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2012
CompletedResults Posted
Study results publicly available
June 17, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2021
CompletedMarch 30, 2025
March 1, 2025
3.8 years
July 22, 2008
January 4, 2013
March 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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)
Overall Survival
From randomization until date of death from any cause, assessed up to approximately 62 months
Overall Response Rate (ORR) as Assessed by Independent Review
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
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)
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
From study treatment start date till 28 days safety follow-up, assessed up to approximately 152 months
- +12 more secondary outcomes
Other Outcomes (1)
All Collected Deaths
Pre-treatment deaths: Up to 21 days prior to treatment. On-treatment deaths: Up to 129 months. Post-treatment deaths: up to 152 months.
Study Arms (2)
Sunitinib
ACTIVE COMPARATORControl arm
Pazopanib
EXPERIMENTALExperimental arm
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (227)
Novartis Investigative Site
Huntsville, Alabama, 35805, United States
Novartis Investigative Site
Tucson, Arizona, 85710, United States
Novartis Investigative Site
Little Rock, Arkansas, 72205, United States
Novartis Investigative Site
Beverly Hills, California, 90211, United States
Novartis Investigative Site
Escondido, California, 92025, United States
Novartis Investigative Site
Fresno, California, 93720, United States
Novartis Investigative Site
Greenbrae, California, 94904-2007, United States
Novartis Investigative Site
Hayward, California, 94545, United States
Novartis Investigative Site
La Jolla, California, 92037, United States
Novartis Investigative Site
Los Angeles, California, 90095, United States
Novartis Investigative Site
Montebello, California, 90640, United States
Novartis Investigative Site
Oakland, California, 94611, United States
Novartis Investigative Site
Orange, California, 92868, United States
Novartis Investigative Site
Roseville, California, 95661, United States
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Sacramento, California, 95817, United States
Novartis Investigative Site
Sacramento, California, 95825, United States
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San Bernardino, California, 92404, United States
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San Francisco, California, 94115, United States
Novartis Investigative Site
San Jose, California, 95119-1110, United States
Novartis Investigative Site
Santa Clara, California, 95051, United States
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South San Francisco, California, 94080, United States
Novartis Investigative Site
Vallejo, California, 94589, United States
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Walnut Creek, California, 94596, United States
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Denver, Colorado, 80218, United States
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Southington, Connecticut, 06489, United States
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Trumbull, Connecticut, 06611, United States
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Washington D.C., District of Columbia, 20007, United States
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Fort Myers, Florida, 33916, United States
Novartis Investigative Site
Miami, Florida, 33136, United States
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Orlando, Florida, 32806, United States
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Atlanta, Georgia, 30318, United States
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Chicago, Illinois, 60612, United States
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Elk Grove Village, Illinois, 60007, United States
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Maywood, Illinois, 60153, United States
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Peoria, Illinois, 61615-7822, United States
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Carmel, Indiana, 46032, United States
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Indianapolis, Indiana, 46202, United States
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Indianapolis, Indiana, 46237, United States
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Cedar Rapids, Iowa, 52403, United States
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Louisville, Kentucky, 40202, United States
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Paducah, Kentucky, 42003, United States
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Annapolis, Maryland, 21401, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02115, United States
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Boston, Massachusetts, 02215, United States
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Worcester, Massachusetts, 01608, United States
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Detroit, Michigan, 48201, United States
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Duluth, Minnesota, 55805, United States
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Minneapolis, Minnesota, 55455, United States
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Tupelo, Mississippi, 38801, United States
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Kansas City, Missouri, 64118, United States
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Kansas City, Missouri, 64131, United States
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Lincoln, Nebraska, 68510, United States
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Las Vegas, Nevada, 89135, United States
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Las Vegas, Nevada, 89169, United States
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Lebanon, New Hampshire, 03756, United States
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Hackensack, New Jersey, 07601, United States
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Buffalo, New York, 14215, United States
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New York, New York, 10032, United States
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New York, New York, 10065, United States
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Hickory, North Carolina, 28602, United States
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Raleigh, North Carolina, 27607, United States
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Cincinnati, Ohio, 45242, United States
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Cleveland, Ohio, 44106, United States
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Columbus, Ohio, 43210, United States
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Columbus, Ohio, 43219, United States
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Dayton, Ohio, 45429, United States
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Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74136, United States
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Eugene, Oregon, 97401, United States
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Portland, Oregon, 97213, United States
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Philadelphia, Pennsylvania, 19102, United States
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Philadelphia, Pennsylvania, 19111, United States
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Charleston, South Carolina, 29403, United States
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Charleston, South Carolina, 29425, United States
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Greenville, South Carolina, 29605, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Arlington, Texas, 76012, United States
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Bedford, Texas, 76022, United States
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Corpus Christi, Texas, 78463-3069, United States
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Dallas, Texas, 75246, United States
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Fort Worth, Texas, 76104, United States
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Lubbock, Texas, 79410, United States
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Round Rock, Texas, 78681, United States
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San Antonio, Texas, 78229, United States
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Tyler, Texas, 75702, United States
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Webster, Texas, 77598-4420, United States
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Wichita Falls, Texas, 76310, United States
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Charlottesville, Virginia, 22903, United States
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Hampton, Virginia, 23666, United States
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Richmond, Virginia, 23230, United States
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Salem, Virginia, 24153, United States
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Seattle, Washington, 98101, United States
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Seattle, Washington, 98109, United States
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Camperdown, New South Wales, 2050, Australia
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Kogarah, New South Wales, 2217, Australia
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Randwick, New South Wales, 2031, Australia
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Waratah, New South Wales, 2298, Australia
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Westmead, New South Wales, 2145, Australia
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Bedford Park, South Australia, 5042, Australia
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Hobart, Tasmania, 7000, Australia
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Heidelberg, Victoria, 3084, Australia
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Wodonga, Victoria, 3690, Australia
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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Moncton, New Brunswick, E1C 6Z8, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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London, Ontario, N6A 4L6, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Guangzhou, Guangdong, 510060, China
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Nanjing, Jiangsu, 210002, China
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Beijing, 100021, China
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Beijing, 100034, China
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Beijing, 100036, China
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Beijing, 100853, China
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Shanghai, 200032, China
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Shanghai, 200127, China
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Tianjin, 300060, China
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Kirchheim, Baden-Wurttemberg, 73230, Germany
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Sigmaringen, Baden-Wurttemberg, 72488, Germany
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Stuttgart, Baden-Wurttemberg, 70174, Germany
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Munich, Bavaria, 81377, Germany
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Planegg, Bavaria, 82152, Germany
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Marburg, Hesse, 35043, Germany
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Offenbach, Hesse, 63069, Germany
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Hanover, Lower Saxony, 30171, Germany
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Aachen, North Rhine-Westphalia, 52074, Germany
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Bonn, North Rhine-Westphalia, 53127, Germany
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Dortmund, North Rhine-Westphalia, 44145, Germany
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Duisburg, North Rhine-Westphalia, 47053, Germany
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Düsseldorf, North Rhine-Westphalia, 40225, Germany
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Essen, North Rhine-Westphalia, 45122, Germany
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Homburg, Saarland, 66421, Germany
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Dresden, Saxony, 01307, Germany
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Leipzig, Saxony, 04103, Germany
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Plauen, Saxony, 08523, Germany
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Eisleben Lutherstadt, Saxony-Anhalt, 06295, Germany
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Magdeburg, Saxony-Anhalt, 39104, Germany
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Berlin, 10117, Germany
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Berlin, 10719, Germany
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Dublin, 7, Ireland
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Dublin, 8, Ireland
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Dublin, 9, Ireland
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Galway, Ireland
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Tallaght, Dublin, 24, Ireland
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Napoli, Campania, 80131, Italy
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Meldola (FC), Emilia-Romagna, 47014, Italy
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Ravenna, Emilia-Romagna, 48100, Italy
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Pordenone, Friuli Venezia Giulia, 33170, Italy
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Rome, Lazio, 00152, Italy
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Milan, Lombardy, 20141, Italy
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Arezzo, Tuscany, 52100, Italy
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Ehime, 791-0280, Japan
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Fukuoka, 812-0033, Japan
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Fukuoka, 812-8582, Japan
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Hokkaido, 060-8543, Japan
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Hokkaido, 060-8648, Japan
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Ibaraki, 305-8576, Japan
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Kanagawa, 236-0004, Japan
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Kyoto, 606-8507, Japan
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Numakunai, 020-8505, Japan
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Okayama, 700-8558, Japan
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Osaka, 565-0871, Japan
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Osaka, 589-8511, Japan
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Shizuoka, 431-3192, Japan
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Tokyo, 104-0045, Japan
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Tokyo, 113-8655, Japan
Novartis Investigative Site
Tokyo, 135-8550, Japan
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Tokyo, 160-8582, Japan
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Tokyo, 162-8666, Japan
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Tokyo, 173-8606, Japan
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Yamagata, 990-9585, Japan
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Alkmaar, 1815 JD, Netherlands
Novartis Investigative Site
Amsterdam, 1066 CX, Netherlands
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Breda, 4819 EV, Netherlands
Novartis Investigative Site
Groningen, 9713 GZ, Netherlands
Novartis Investigative Site
Sittard-geleen, 6162 BG, Netherlands
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The Hague, 2545CH, Netherlands
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Tilburg, 5022 GC, Netherlands
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Utrecht, 3584 CX, Netherlands
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Daegu, 700-721, South Korea
Novartis Investigative Site
Daejeon, 301-721, South Korea
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Goyang-si, Gyeonggi-Do, 410-769, South Korea
Novartis Investigative Site
Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 138-736, South Korea
Novartis Investigative Site
Badalona, 08916, Spain
Novartis Investigative Site
Barakaldo (Vizcaya), 48903, Spain
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Barcelona, 08036, Spain
Novartis Investigative Site
Girona, 17007, Spain
Novartis Investigative Site
Madrid, 28033, Spain
Novartis Investigative Site
Madrid, 28040, Spain
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Madrid, 28041, Spain
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Pamplona, 31008, Spain
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Lund, SE-221 85, Sweden
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Stockholm, SE-171 76, Sweden
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Uppsala, SE-751 85, Sweden
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Kaohsiung Hsien, 833, Taiwan
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Taichung, 40402, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan District, 333, Taiwan
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Bristol, Gloucestershire, BS2 8ED, United Kingdom
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Northwood, Middlesex, HA6 2RN, United Kingdom
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Bebington, Wirral, CH63 4JY, United Kingdom
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Birmingham, B15 2TH, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Glasgow, G12 OYN, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Sheffield, S10 2SJ, United Kingdom
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Swansea, SA2 8QA, United Kingdom
Related Publications (10)
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.
PMID: 37146227DERIVEDSheng 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.
PMID: 32171288DERIVEDSternberg 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.
PMID: 31601514DERIVEDGuo 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.
PMID: 29788981DERIVEDGrunwald 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.
PMID: 29654533DERIVEDBeaumont 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.
PMID: 27000445DERIVEDGoldstein 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.
PMID: 26702763DERIVEDSorich 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.
PMID: 26685869DERIVEDLai 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.
PMID: 26457466DERIVEDMotzer 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.
PMID: 23964934DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This is a legacy GlaxoSmithKline (GSK) study and the primary CSR was completed by GSK prior to the study sponsorship handover. The full investigators lists and other appendices were not transferred over during the change in sponsorship from GSK to Novartis and therefore, the team could not confirm or quality control the investigator sites list.
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2008
First Posted
July 23, 2008
Study Start
August 14, 2008
Primary Completion
May 21, 2012
Study Completion
March 24, 2021
Last Updated
March 30, 2025
Results First Posted
June 17, 2013
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com