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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00720941
First received: July 22, 2008
Last updated: January 30, 2014
Last verified: October 2013
  Purpose

This study is being conducted to provide a direct comparison of the efficacy, safety and tolerability for pazopanib and sunitinib (SUTENT)


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Pazopanib
Drug: Sunitinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study VEG108844, A Study of Pazopanib Versus Sunitinib in the Treatment of Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: From randomization until the earliest date of disease progression or death (up to Study Week 191) ] [ Designated as safety issue: No ]
    PFS is 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. The Kaplan-Meier method was used for PFS estimates.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From randomization until death (up to Study Week 191) ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from randomization until death due to any cause.

  • Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review [ Time Frame: From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167) ] [ Designated as safety issue: No ]
    The number of participants with evidence of CR (the disappearance of all target and non-target lesions), 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), or Progressive Disease (a >=20% increase in target lesions within the first 12 weeks of treatment) was evaluated by an independent review per RECIST, Version 1.

  • Time to Response [ Time Frame: From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167) ] [ Designated as safety issue: No ]
    Time to response is 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.

  • Duration of Response (DOR) [ Time Frame: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167) ] [ Designated as safety issue: No ]
    DOR is 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.

  • Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment) [ Time Frame: From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 167) ] [ Designated as safety issue: No ]
    See the SAE/AE module for a list of all SAEs/AEs. SAE=any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly/birth defect, or a Grade 4 laboratory abnormality. Events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment.

  • Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively) [ Time Frame: Baseline (predose); Weeks 4, 10, 16, and 22 ] [ Designated as safety issue: No ]
    The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life (HRQoL) experienced in the past seven days. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). A negative change from Baseline represents a worsening condition. Change from Baseline was calculated as the assessment week value minus the Baseline value.

  • 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 (Average of Weeks 4, 10, 16, and 22, Respectively) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ] [ Designated as safety issue: No ]
    The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.

  • 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 (Average of Weeks 4, 10, 16, and 22, Respectively) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ] [ Designated as safety issue: No ]
    The FKSI-19 is a disease-specific instrument measuring disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative change from Baseline (BL) represents a worsening of condition. Change from BL was calculated as the assessment week value minus the BL value.

  • 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 (Average of Weeks 4, 10, 16, and 22, Respectively) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ] [ Designated as safety issue: No ]
    The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12).Higher scores represent better health. A negative change from Baseline represents a worsening of condition.

  • 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 (Average of Weeks 4, 10, 16, and 22, Respectively) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ] [ Designated as safety issue: No ]
    The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.

  • Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ] [ Designated as safety issue: No ]
    The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (DRS-P, DRS-E, TSE, and FWB). 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). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.

  • Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ] [ Designated as safety issue: No ]
    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.

  • 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 (Average of Weeks 4, 10, 16, and 22, Respectively) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ] [ Designated as safety issue: No ]
    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 (par.) 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.

  • Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ] [ Designated as safety issue: No ]
    The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Par. 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.

  • Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively) [ Time Frame: Weeks 4, 10, 16, and 22 ] [ Designated as safety issue: No ]
    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 health.

  • Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24 [ Time Frame: From Day 1 up to Week 24 ] [ Designated as safety issue: No ]
    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.

  • MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively) [ Time Frame: Weeks 4, 10, 16, and 22 ] [ Designated as safety issue: No ]
    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.


Enrollment: 927
Study Start Date: August 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

This study will evaluate the efficacy and safety of pazopanib compared to sunitinib in subjects with advanced RCC who have received no prior systemic therapy for advanced or metastatic RCC. Subjects will be randomized in a 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 are 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 will continue until subjects experience disease progression, unacceptable toxicity, withdraw consent, or death.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720941

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

Publications:
Cella D, Hacksaw M, Diaz J, et al. Quality of life (QoL) among renal cell carcinoma (RCC) patients treated with pazopanib versus sunitinib in the COMPARZ study. J Clin Oncol. 2013;31(Suppl 6):abstr 346.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00720941     History of Changes
Other Study ID Numbers: 108844
Study First Received: July 22, 2008
Results First Received: January 4, 2013
Last Updated: January 30, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Agenzia Italiana del Farmaco
Japan: Pharmaceutical and Medical Device Agency
Canada: Health Canada
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Sweden: Medical Products Agency
China: Food and Drug Administration
United States: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
SUTENT
Locally advanced and/or metastatic renal cell carcinoma
Pazopanib
Sunitinib
GW786034
Renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014