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

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ClinicalTrials.gov Identifier: NCT00720941
Recruitment Status : Active, not recruiting
First Posted : July 23, 2008
Results First Posted : June 17, 2013
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Randomized;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carcinoma, Renal Cell
Interventions: Drug: Pazopanib
Drug: Sunitinib

  Participant Flow

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

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.
No text entered.

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

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From randomization until the earliest date of disease progression or death (up to Study Week 191) ]
  Show Outcome Measure 1

2.  Secondary:   Overall Survival   [ Time Frame: From randomization until death (up to Study Week 268) ]
  Show Outcome Measure 2

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) ]
  Show Outcome Measure 3

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) ]
  Show Outcome Measure 4

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 ]
  Hide Outcome Measure 10

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   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


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information