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

Carcinoma, Renal Cell Clinical Trial

— COMPARZ  

Official title:

Study VEG108844, A Study of Pazopanib Versus Sunitinib in the Treatment of Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720941
• Other study ID #: 108844
• Secondary ID: 2008-002102-19CP
• Status: Completed
• Phase: Phase 3
• Start date: August 14, 2008
• Est. completion date: March 24, 2021

Study information

• Verified date: April 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 927
• Est. completion date: March 24, 2021
• Est. primary completion date: May 21, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Bedford Park	South Australia
Australia	Novartis Investigative Site	Camperdown	New South Wales
Australia	Novartis Investigative Site	Heidelberg	Victoria
Australia	Novartis Investigative Site	Hobart	Tasmania
Australia	Novartis Investigative Site	Kogarah	New South Wales
Australia	Novartis Investigative Site	Randwick	New South Wales
Australia	Novartis Investigative Site	Waratah	New South Wales
Australia	Novartis Investigative Site	Westmead	New South Wales
Australia	Novartis Investigative Site	Wodonga	Victoria
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Moncton	New Brunswick
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Oshawa	Ontario
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Winnipeg	Manitoba
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Tianjin
Germany	Novartis Investigative Site	Aachen	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Dortmund	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Dresden	Sachsen
Germany	Novartis Investigative Site	Duesseldorf	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Duisburg	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Eisleben	Sachsen-Anhalt
Germany	Novartis Investigative Site	Essen	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Homburg	Saarland
Germany	Novartis Investigative Site	Kirchheim	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Leipzig	Sachsen
Germany	Novartis Investigative Site	Magdeburg	Sachsen-Anhalt
Germany	Novartis Investigative Site	Marburg	Hessen
Germany	Novartis Investigative Site	Muenchen	Bayern
Germany	Novartis Investigative Site	Offenbach	Hessen
Germany	Novartis Investigative Site	Planegg	Bayern
Germany	Novartis Investigative Site	Plauen	Sachsen
Germany	Novartis Investigative Site	Sigmaringen	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Stuttgart	Baden-Wuerttemberg
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Galway
Ireland	Novartis Investigative Site	Tallaght, Dublin
Italy	Novartis Investigative Site	Arezzo	Toscana
Italy	Novartis Investigative Site	Meldola (FC)	Emilia-Romagna
Italy	Novartis Investigative Site	Milano	Lombardia
Italy	Novartis Investigative Site	Napoli	Campania
Italy	Novartis Investigative Site	Pordenone	Friuli-Venezia-Giulia
Italy	Novartis Investigative Site	Ravenna	Emilia-Romagna
Italy	Novartis Investigative Site	Roma	Lazio
Japan	Novartis Investigative Site	Ehime
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Hokkaido
Japan	Novartis Investigative Site	Hokkaido
Japan	Novartis Investigative Site	Ibaraki
Japan	Novartis Investigative Site	Iwate
Japan	Novartis Investigative Site	Kanagawa
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Okayama
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Shizuoka
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Yamagata
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Daejeon
Korea, Republic of	Novartis Investigative Site	Goyang-si, Gyeonggi-Do
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Netherlands	Novartis Investigative Site	Alkmaar
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Breda
Netherlands	Novartis Investigative Site	Den Haag
Netherlands	Novartis Investigative Site	Groningen
Netherlands	Novartis Investigative Site	Sittard-geleen
Netherlands	Novartis Investigative Site	Tilburg
Netherlands	Novartis Investigative Site	Utrecht
Spain	Novartis Investigative Site	Badalona
Spain	Novartis Investigative Site	Barakaldo (Vizcaya)
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Gerona
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Pamplona
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Uppsala
Taiwan	Novartis Investigative Site	Kaohsiung Hsien
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taoyuan
United Kingdom	Novartis Investigative Site	Bebington, Wirral
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Bristol	Gloucestershire
United Kingdom	Novartis Investigative Site	Cambridge
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Leeds
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Northwood	Middlesex
United Kingdom	Novartis Investigative Site	Nottingham
United Kingdom	Novartis Investigative Site	Sheffield
United Kingdom	Novartis Investigative Site	Swansea
United States	Novartis Investigative Site	Annapolis	Maryland
United States	Novartis Investigative Site	Arlington	Texas
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Bedford	Texas
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Buffalo	New York
United States	Novartis Investigative Site	Carmel	Indiana
United States	Novartis Investigative Site	Cedar Rapids	Iowa
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charlottesville	Virginia
United States	Novartis Investigative Site	Chattanooga	Tennessee
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Corpus Christi	Texas
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Dayton	Ohio
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Duluth	Minnesota
United States	Novartis Investigative Site	Elk Grove Village	Illinois
United States	Novartis Investigative Site	Escondido	California
United States	Novartis Investigative Site	Eugene	Oregon
United States	Novartis Investigative Site	Fort Myers	Florida
United States	Novartis Investigative Site	Fort Worth	Texas
United States	Novartis Investigative Site	Fresno	California
United States	Novartis Investigative Site	Greenbrae	California
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigative Site	Hackensack	New Jersey
United States	Novartis Investigative Site	Hampton	Virginia
United States	Novartis Investigative Site	Hayward	California
United States	Novartis Investigative Site	Hickory	North Carolina
United States	Novartis Investigative Site	Huntsville	Alabama
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Kansas City	Missouri
United States	Novartis Investigative Site	Kansas City	Missouri
United States	Novartis Investigative Site	La Jolla	California
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Lebanon	New Hampshire
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Lubbock	Texas
United States	Novartis Investigative Site	Maywood	Illinois
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Montebello	California
United States	Novartis Investigative Site	Mount Pleasant	South Carolina
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Oakland	California
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Orlando	Florida
United States	Novartis Investigative Site	Paducah	Kentucky
United States	Novartis Investigative Site	Peoria	Illinois
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Roseville	California
United States	Novartis Investigative Site	Round Rock	Texas
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Salem	Virginia
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Bernardino	California
United States	Novartis Investigative Site	San Francisco	California
United States	Novartis Investigative Site	San Jose	California
United States	Novartis Investigative Site	Santa Clara	California
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	South San Francisco	California
United States	Novartis Investigative Site	Southington	Connecticut
United States	Novartis Investigative Site	Trumbull	Connecticut
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Tulsa	Oklahoma
United States	Novartis Investigative Site	Tupelo	Mississippi
United States	Novartis Investigative Site	Tyler	Texas
United States	Novartis Investigative Site	Vallejo	California
United States	Novartis Investigative Site	Walnut Creek	California
United States	Novartis Investigative Site	Washington	District of Columbia
United States	Novartis Investigative Site	Webster	Texas
United States	Novartis Investigative Site	Wichita Falls	Texas
United States	Novartis Investigative Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Germany,  Ireland,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)	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.	From randomization until the earliest date of disease progression or death (up to Study Week 191)
Secondary	Overall Survival	Overall survival is defined as the time from randomization until death due to any cause.	From randomization until death (up to Study Week 268)
Secondary	Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review	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.	From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167)
Secondary	Time to Response	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.	From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167)
Secondary	Duration of Response (DOR)	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.	From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167)
Secondary	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)	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.	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)
Secondary	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)	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.	Baseline (predose); Weeks 4, 10, 16, and 22
Secondary	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)	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.	Baseline; Weeks 4, 10, 16, and 22
Secondary	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)	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.	Baseline; Weeks 4, 10, 16, and 22
Secondary	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)	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.	Baseline; Weeks 4, 10, 16, and 22
Secondary	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)	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.	Baseline; Weeks 4, 10, 16, and 22
Secondary	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)	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.	Baseline; Weeks 4, 10, 16, and 22
Secondary	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)	The SQLQ scale consists of 5 items that assess the worst mouth and throat, hand, and foot soreness, as well as limitations due to mouth/throat and foot soreness. Participants were asked to assess their worst mouth/throat, hand, and foot soreness by answering the question of " In the past 4 weeks, what was your worst mouth/throat, hand, and foot soreness?" by using the following 4-point scale: 0, I never had any soreness; 1, I had a little bit of soreness; 2, I had quite a lot of soreness; 3, I had severe soreness. A positive mean change from Baseline represents a worsening of condition.	Baseline; Weeks 4, 10, 16, and 22
Secondary	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)	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.	Baseline; Weeks 4, 10, 16, and 22
Secondary	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)	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.	Baseline; Weeks 4, 10, 16, and 22
Secondary	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)	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.	Weeks 4, 10, 16, and 22
Secondary	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	Non-study medical visits were defined as the sum of primary care physician visits, nurse practitioner/physician's assistant/nurse visits, and medical or surgical specialist visits. Days hospitalized were defined as the sum of days in the general ward and days in intensive care. The number of telephone consultations and ER visits was assessed via individual questions on the electronic Case Report Form. The endpoint was totaled through Week 24, divided by the number of days on treatment for each participant, then multiplied by 30 days to get the number of visits per 30 days.	From Day 1 up to Week 24
Secondary	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)	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.	Weeks 4, 10, 16, and 22