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: March 21, 2017

Last verified: March 2017

History of Changes

Results First Received: January 4, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: No masking; Primary Purpose: Treatment
Condition:	Carcinoma, Renal Cell
Interventions:	Drug: Pazopanib Drug: Sunitinib

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Per protocol amendment, the number of participants (par.) was increased to ~1100 (including all par. enrolled in Studies VEG108844 and VEG113078 [NCT01147822; a substudy in Asian par.]). This summary is a pooled analysis of both studies. 1110 par. were analyzed; 927 from VEG108844 (reflected in the protocol enrollment field), 183 from VEG113078.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were stratified based on Karnofsky Performance Scale scores (70 or 80; 90 or 100), Baseline levels of lactate dehydrogenase (>1.5 versus <=1.5 times the upper limit of normal [ULN]), and previous nephrectomy (yes versus no) and were randomized in a 1:1 ratio to receive either pazopanib or sunitinib.

Reporting Groups

	Description
Pazopanib 800 mg	Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg	Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Participant Flow: Overall Study

	Pazopanib 800 mg	Sunitinib 50 mg
STARTED	557	553
Ongoing	34	23
COMPLETED	144	138
NOT COMPLETED	413	415
Death	334	335
Protocol Violation	0	2
Lost to Follow-up	17	15
Physician Decision	1	5
Withdrawal by Subject	27	35
Ongoing	34	23

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Pazopanib 800 mg	Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg	Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Total	Total of all reporting groups

Baseline Measures

	Pazopanib 800 mg	Sunitinib 50 mg	Total
Overall Participants Analyzed [Units: Participants]	557	553	1110

Age [Units: Years] Mean (Standard Deviation)	60.9 (10.89)	61.2 (10.98)	61.1 (10.93)

Sex: Female, Male [Units: Participants] Count of Participants
Female	159 28.5%	138 25.0%	297 26.8%
Male	398 71.5%	415 75.0%	813 73.2%

Race/Ethnicity, Customized [Units: Participants]
African American/African Heritage	10	5	15
American Indian or Alaska Native	3	0	3
Asian	194	188	382
White	349	358	707
American Indian or Alaska Native & White	0	1	1
Unknown	1	1	2

Outcome Measures

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1. Primary:

Progression-free Survival (PFS) [ Time Frame: From randomization until the earliest date of disease progression or death (up to Study Week 191) ]

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2. Secondary:

Overall Survival [ Time Frame: From randomization until death (up to Study Week 268) ]

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3. Secondary:

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) ]

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4. Secondary:

Time to Response [ Time Frame: From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167) ]

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5. Secondary:

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) ]

Show Outcome Measure 5

6. 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) [ 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) ]

Show Outcome Measure 6

7. 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) [ Time Frame: Baseline (predose); Weeks 4, 10, 16, and 22 ]

Show Outcome Measure 7

8. 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) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Show Outcome Measure 8

9. 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) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Show Outcome Measure 9

10. 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) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

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Measure Type	Secondary
Measure Title	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)
Measure Description	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.
Time Frame	Baseline; Weeks 4, 10, 16, and 22

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.

Reporting Groups

	Description
Pazopanib 800 mg	Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg	Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values

	Pazopanib 800 mg	Sunitinib 50 mg
Participants Analyzed [Units: Participants]	326	350
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) [Units: Scores on a scale] Mean (Standard Deviation)
Week 4, n=326, 350	-1.5 (2.45)	-2.0 (2.35)
Week 10, n=267, 305	-1.9 (2.66)	-2.4 (2.62)
Week 16, n=244, 254	-2.1 (2.79)	-2.8 (2.46)
Week 22, n=201, 218	-2.4 (2.75)	-2.4 (2.33)

No statistical analysis provided for 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)

11. 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) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Show Outcome Measure 11

12. 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) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Show Outcome Measure 12

13. 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) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Show Outcome Measure 13

14. 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) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Show Outcome Measure 14

15. 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) [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Show Outcome Measure 15

16. 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) [ Time Frame: Weeks 4, 10, 16, and 22 ]

Show Outcome Measure 16

17. 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 [ Time Frame: From Day 1 up to Week 24 ]

Show Outcome Measure 17

18. 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) [ Time Frame: Weeks 4, 10, 16, and 22 ]

Show Outcome Measure 18

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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