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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):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00720941
First received: July 22, 2008
Last updated: August 15, 2016
Last verified: August 2016
  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
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 Novartis:

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 268) ] [ 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 268) ] [ 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: May 2017
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis Pharmaceuticals
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: August 15, 2016
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 Novartis:
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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 28, 2016