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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
Results First Received: January 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Masking: Open Label;   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) 
Gender 
[Units: Participants]
     
Female   159   138   297 
Male   398   415   813 
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) ]

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

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) ]

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) ]

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) ]

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) ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Participants were analyzed 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).
Additional Description Serious adverse events (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication, according to the actual treatment received.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    Pazopanib 800 mg   Sunitinib 50 mg
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   541/554 (97.65%)   535/548 (97.63%) 
Blood and lymphatic system disorders     
Neutropenia † 1     
# participants affected / at risk   60/554 (10.83%)   146/548 (26.64%) 
Thrombocytopenia † 1     
# participants affected / at risk   56/554 (10.11%)   180/548 (32.85%) 
Leukopenia † 1     
# participants affected / at risk   51/554 (9.21%)   99/548 (18.07%) 
Anaemia † 1     
# participants affected / at risk   36/554 (6.50%)   99/548 (18.07%) 
Endocrine disorders     
Hypothyroidism † 1     
# participants affected / at risk   71/554 (12.82%)   136/548 (24.82%) 
Hyperthyroidism † 1     
# participants affected / at risk   7/554 (1.26%)   29/548 (5.29%) 
Eye disorders     
Eyelid oedema † 1     
# participants affected / at risk   19/554 (3.43%)   42/548 (7.66%) 
Gastrointestinal disorders     
Diarrhoea † 1     
# participants affected / at risk   349/554 (63.00%)   312/548 (56.93%) 
Nausea † 1     
# participants affected / at risk   246/554 (44.40%)   249/548 (45.44%) 
Vomiting † 1     
# participants affected / at risk   157/554 (28.34%)   148/548 (27.01%) 
Constipation † 1     
# participants affected / at risk   97/554 (17.51%)   133/548 (24.27%) 
Dyspepsia † 1     
# participants affected / at risk   80/554 (14.44%)   134/548 (24.45%) 
Stomatitis † 1     
# participants affected / at risk   78/554 (14.08%)   153/548 (27.92%) 
Abdominal pain † 1     
# participants affected / at risk   70/554 (12.64%)   72/548 (13.14%) 
Abdominal pain upper † 1     
# participants affected / at risk   70/554 (12.64%)   48/548 (8.76%) 
Abdominal distension † 1     
# participants affected / at risk   33/554 (5.96%)   24/548 (4.38%) 
Flatulence † 1     
# participants affected / at risk   32/554 (5.78%)   15/548 (2.74%) 
Dry mouth † 1     
# participants affected / at risk   26/554 (4.69%)   29/548 (5.29%) 
Abdominal discomfort † 1     
# participants affected / at risk   24/554 (4.33%)   34/548 (6.20%) 
Mouth ulceration † 1     
# participants affected / at risk   23/554 (4.15%)   37/548 (6.75%) 
Gastrooesophageal reflux disease † 1     
# participants affected / at risk   20/554 (3.61%)   57/548 (10.40%) 
General disorders     
Fatigue † 1     
# participants affected / at risk   305/554 (55.05%)   343/548 (62.59%) 
Mucosal inflammation † 1     
# participants affected / at risk   61/554 (11.01%)   141/548 (25.73%) 
Oedema peripheral † 1     
# participants affected / at risk   56/554 (10.11%)   85/548 (15.51%) 
Asthenia † 1     
# participants affected / at risk   48/554 (8.66%)   58/548 (10.58%) 
Pyrexia † 1     
# participants affected / at risk   47/554 (8.48%)   77/548 (14.05%) 
Chills † 1     
# participants affected / at risk   15/554 (2.71%)   43/548 (7.85%) 
Oedema † 1     
# participants affected / at risk   16/554 (2.89%)   36/548 (6.57%) 
Face oedema † 1     
# participants affected / at risk   12/554 (2.17%)   40/548 (7.30%) 
Infections and infestations     
Nasopharyngitis † 1     
# participants affected / at risk   46/554 (8.30%)   46/548 (8.39%) 
Upper respiratory tract infection † 1     
# participants affected / at risk   30/554 (5.42%)   34/548 (6.20%) 
Urinary tract infection † 1     
# participants affected / at risk   22/554 (3.97%)   29/548 (5.29%) 
Investigations     
Alanine aminotransferase increased † 1     
# participants affected / at risk   143/554 (25.81%)   93/548 (16.97%) 
Aspartate aminotransferase increased † 1     
# participants affected / at risk   131/554 (23.65%)   98/548 (17.88%) 
Weight decreased † 1     
# participants affected / at risk   85/554 (15.34%)   33/548 (6.02%) 
Blood creatinine increased † 1     
# participants affected / at risk   59/554 (10.65%)   93/548 (16.97%) 
Blood bilirubin increased † 1     
# participants affected / at risk   51/554 (9.21%)   35/548 (6.39%) 
Blood alkaline phosphatase increased † 1     
# participants affected / at risk   40/554 (7.22%)   30/548 (5.47%) 
Lipase increased † 1     
# participants affected / at risk   42/554 (7.58%)   32/548 (5.84%) 
Blood lactate dehydrogenase increased † 1     
# participants affected / at risk   40/554 (7.22%)   60/548 (10.95%) 
Platelet count decreased † 1     
# participants affected / at risk   36/554 (6.50%)   97/548 (17.70%) 
Amylase increased † 1     
# participants affected / at risk   37/554 (6.68%)   24/548 (4.38%) 
Haemoglobin decreased † 1     
# participants affected / at risk   34/554 (6.14%)   5/548 (0.91%) 
Blood thyroid stimulating hormone increased † 1     
# participants affected / at risk   32/554 (5.78%)   66/548 (12.04%) 
White blood cell count decreased † 1     
# participants affected / at risk   31/554 (5.60%)   74/548 (13.50%) 
Neutrophil count decreased † 1     
# participants affected / at risk   27/554 (4.87%)   62/548 (11.31%) 
Blood triglycerides increased † 1     
# participants affected / at risk   21/554 (3.79%)   35/548 (6.39%) 
Metabolism and nutrition disorders     
Decreased appetite † 1     
# participants affected / at risk   207/554 (37.36%)   203/548 (37.04%) 
Hypophosphataemia † 1     
# participants affected / at risk   21/554 (3.79%)   32/548 (5.84%) 
Hyponatraemia † 1     
# participants affected / at risk   22/554 (3.97%)   36/548 (6.57%) 
Hyperglycaemia † 1     
# participants affected / at risk   16/554 (2.89%)   30/548 (5.47%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1     
# participants affected / at risk   90/554 (16.25%)   89/548 (16.24%) 
Arthralgia † 1     
# participants affected / at risk   77/554 (13.90%)   67/548 (12.23%) 
Pain in extremity † 1     
# participants affected / at risk   68/554 (12.27%)   93/548 (16.97%) 
Musculoskeletal pain † 1     
# participants affected / at risk   43/554 (7.76%)   28/548 (5.11%) 
Muscle spasms † 1     
# participants affected / at risk   37/554 (6.68%)   22/548 (4.01%) 
Myalgia † 1     
# participants affected / at risk   35/554 (6.32%)   41/548 (7.48%) 
Flank pain † 1     
# participants affected / at risk   14/554 (2.53%)   30/548 (5.47%) 
Nervous system disorders     
Dysgeusia † 1     
# participants affected / at risk   144/554 (25.99%)   198/548 (36.13%) 
Headache † 1     
# participants affected / at risk   124/554 (22.38%)   122/548 (22.26%) 
Dizziness † 1     
# participants affected / at risk   70/554 (12.64%)   82/548 (14.96%) 
Psychiatric disorders     
Insomnia † 1     
# participants affected / at risk   59/554 (10.65%)   61/548 (11.13%) 
Renal and urinary disorders     
Proteinuria † 1     
# participants affected / at risk   99/554 (17.87%)   76/548 (13.87%) 
Hematuria † 1     
# participants affected / at risk   24/554 (4.33%)   28/548 (5.11%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1     
# participants affected / at risk   86/554 (15.52%)   104/548 (18.98%) 
Dyspnoea † 1     
# participants affected / at risk   77/554 (13.90%)   92/548 (16.79%) 
Epistaxis † 1     
# participants affected / at risk   49/554 (8.84%)   96/548 (17.52%) 
Dysphonia † 1     
# participants affected / at risk   42/554 (7.58%)   12/548 (2.19%) 
Oropharyngeal pain † 1     
# participants affected / at risk   39/554 (7.04%)   54/548 (9.85%) 
Skin and subcutaneous tissue disorders     
Hair colour changes † 1     
# participants affected / at risk   168/554 (30.32%)   53/548 (9.67%) 
Palmar-plantar erythrodysaesthesia syndrome † 1     
# participants affected / at risk   163/554 (29.42%)   275/548 (50.18%) 
Rash † 1     
# participants affected / at risk   96/554 (17.33%)   126/548 (22.99%) 
Alopecia † 1     
# participants affected / at risk   77/554 (13.90%)   45/548 (8.21%) 
Dry skin † 1     
# participants affected / at risk   44/554 (7.94%)   47/548 (8.58%) 
Skin hypopigmentation † 1     
# participants affected / at risk   27/554 (4.87%)   7/548 (1.28%) 
Pruritus † 1     
# participants affected / at risk   22/554 (3.97%)   44/548 (8.03%) 
Yellow skin † 1     
# participants affected / at risk   4/554 (0.72%)   83/548 (15.15%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   256/554 (46.21%)   222/548 (40.51%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



  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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