Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma
NCT ID: NCT00720941
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1110 participants
INTERVENTIONAL
2008-08-14
2021-03-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sunitinib
Control arm
Sunitinib
50 mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment
Pazopanib
Experimental arm
Pazopanib
800 mg administered once daily orally continuous dosing
Interventions
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Pazopanib
800 mg administered once daily orally continuous dosing
Sunitinib
50 mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Huntsville, Alabama, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Escondido, California, United States
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Fresno, California, United States
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Greenbrae, California, United States
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Hayward, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Montebello, California, United States
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Oakland, California, United States
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Orange, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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Sacramento, California, United States
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San Bernardino, California, United States
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San Francisco, California, United States
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San Jose, California, United States
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Santa Clara, California, United States
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South San Francisco, California, United States
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Vallejo, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Southington, Connecticut, United States
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Trumbull, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Elk Grove Village, Illinois, United States
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Maywood, Illinois, United States
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Peoria, Illinois, United States
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Carmel, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Cedar Rapids, Iowa, United States
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Louisville, Kentucky, United States
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Paducah, Kentucky, United States
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Annapolis, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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Duluth, Minnesota, United States
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Minneapolis, Minnesota, United States
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Tupelo, Mississippi, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Hackensack, New Jersey, United States
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Buffalo, New York, United States
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New York, New York, United States
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Philadelphia, Pennsylvania, United States
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Mt. Pleasant, South Carolina, United States
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Camperdown, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Waratah, New South Wales, Australia
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Bedford Park, South Australia, Australia
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Hobart, Tasmania, Australia
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Heidelberg, Victoria, Australia
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Wodonga, Victoria, Australia
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Oshawa, Ontario, Canada
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Montreal, Quebec, Canada
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Guangzhou, Guangdong, China
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Nanjing, Jiangsu, China
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Beijing, , China
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Beijing, , China
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Shanghai, , China
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Tianjin, , China
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Kirchheim, Baden-Wurttemberg, Germany
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Sigmaringen, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Planegg, Bavaria, Germany
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Marburg, Hesse, Germany
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Offenbach, Hesse, Germany
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Hanover, Lower Saxony, Germany
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Aachen, North Rhine-Westphalia, Germany
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Bonn, North Rhine-Westphalia, Germany
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Dortmund, North Rhine-Westphalia, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Homburg, Saarland, Germany
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Dresden, Saxony, Germany
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Leipzig, Saxony, Germany
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Plauen, Saxony, Germany
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Eisleben Lutherstadt, Saxony-Anhalt, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Berlin, , Germany
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Berlin, , Germany
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Dublin, , Ireland
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Galway, , Ireland
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Tallaght, Dublin, , Ireland
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Napoli, Campania, Italy
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Meldola (FC), Emilia-Romagna, Italy
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Ravenna, Emilia-Romagna, Italy
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Pordenone, Friuli Venezia Giulia, Italy
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Rome, Lazio, Italy
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Milan, Lombardy, Italy
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Arezzo, Tuscany, Italy
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Ehime, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Hokkaido, , Japan
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Hokkaido, , Japan
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Ibaraki, , Japan
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Kanagawa, , Japan
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Kyoto, , Japan
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Numakunai, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Shizuoka, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Yamagata, , Japan
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Alkmaar, , Netherlands
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Groningen, , Netherlands
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Sittard-geleen, , Netherlands
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The Hague, , Netherlands
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Tilburg, , Netherlands
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Utrecht, , Netherlands
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Daegu, , South Korea
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Daejeon, , South Korea
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Goyang-si, Gyeonggi-Do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Badalona, , Spain
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Barakaldo (Vizcaya), , Spain
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Barcelona, , Spain
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Girona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Pamplona, , Spain
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Lund, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Kaohsiung Hsien, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bristol, Gloucestershire, United Kingdom
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Northwood, Middlesex, United Kingdom
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Bebington, Wirral, , United Kingdom
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Birmingham, , United Kingdom
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Cambridge, , United Kingdom
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Glasgow, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Nottingham, , United Kingdom
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Sheffield, , United Kingdom
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Swansea, , United Kingdom
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2008-002102-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CPZP034A2301
Identifier Type: OTHER
Identifier Source: secondary_id
VEG108844
Identifier Type: OTHER
Identifier Source: secondary_id
108844
Identifier Type: -
Identifier Source: org_study_id
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