Trial · NCT00720941
Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma
NCT00720941, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2013-06-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma. Trials, record NCT00720941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00720941
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma
- NCT number
- NCT00720941
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,110 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Pazopanib, Sunitinib
- First posted
- 2008-07-23
- Last updated
- 2025-03-30
- Other registries' IDs
- eudract:2008-002102-19
- Results first posted
- 2013-06-17
- Limitations and caveats
This is a legacy GlaxoSmithKline (GSK) study and the primary CSR was completed by GSK prior to the study sponsorship handover. The full investigators lists and other appendices were not transferred over during the change in sponsorship from GSK to Novartis and therefore, the team could not confirm or quality control the investigator sites list.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months | PFS was 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. |
| Secondary | Overall Survival | From randomization until date of death from any cause, assessed up to approximately 62 months | Overall survival was defined as the time from randomization until death due to any cause. |
| Secondary | Overall Response Rate (ORR) as Assessed by Independent Review | From randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months | The number of participants with evidence of Complete Response (CR) (the disappearance of all target and non-target lesions), Partial Response (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, taking as reference the smallest sum LD since the treatment started), or Progressive Disease (a \>=20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started) was evaluated by an independent review per RECIST, Version 1. |
| Secondary | Time to Response | From randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months | Time to response was 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. |
| Secondary | Duration of Response (DOR) | From the date of the first documented response (CR or PR) to the date of first documented progression or death due to any cause, assessed up to approximately 39 months | DOR was 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. |
| Secondary | Number of Participants With Adverse Events | From study treatment start date till 28 days safety follow-up, assessed up to approximately 152 months | The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs), through the monitoring of relevant clinical and laboratory safety parameters. |
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 | Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively) | FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. |
| 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 | Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively) | Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (Disease-Related Symptoms - Physical (FKSI-DRS-P), Disease-Related Symptoms - Emotional (FKSI-DRS-E), Treatment Side-Effects (FKSI-TSE), Function/Well-Being (FKSI-FWB)) experienced in the past 7 days. 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). A negative mean indicates a worsening of condition. |
| 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 | Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively) | Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (Disease-Related Symptoms - Physical (FKSI-DRS-P), Disease-Related Symptoms - Emotional (FKSI-DRS-E), Treatment Side-Effects (FKSI-TSE), Function/Well-Being (FKSI-FWB)) experienced in the past 7 days. 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). A negative mean indicates a worsening of condition. |
| 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 | Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively) | Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (Disease-Related Symptoms - Physical (FKSI-DRS-P), Disease-Related Symptoms - Emotional (FKSI-DRS-E), Treatment Side-Effects (FKSI-TSE), Function/Well-Being (FKSI-FWB)) experienced in the past 7 days. 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). A negative mean indicates a worsening of condition. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months | Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. | Months | MEDIAN |
| SECONDARY | Overall Survival | From randomization until date of death from any cause, assessed up to approximately 62 months | Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) as Assessed by Independent Review | From randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months | Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Response | From randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months | Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Only those participants who experienced either a confirmed CR or a PR were analyzed. | Weeks | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From the date of the first documented response (CR or PR) to the date of first documented progression or death due to any cause, assessed up to approximately 39 months | Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Only those participants who had either a confirmed CR or PR were analyzed. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events | From study treatment start date till 28 days safety follow-up, assessed up to approximately 152 months | Safety Population: all randomized participants who received at least one dose of study medication, according to the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 | Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively) | Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at some of the other early time points were excluded from the analysis at those time points. | Scores on a scale | MEAN |
| 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 | Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively) | Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. 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. | Scores on a scale | MEAN |
| 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 | Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively) | Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. 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. | Scores on a scale | MEAN |
| 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 | Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively) | Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. 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. | Scores on a scale | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group182
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Pazopanib 800 mg | 8.4 | 95% Confidence Interval 8.3 to 10.9 | Months | |
| Progression-free Survival (PFS) | Sunitinib 50 mg | 9.5 | 95% Confidence Interval 8.3 to 11.1 | Months | |
| Overall Survival | Pazopanib 800 mg | 28.3 | 95% Confidence Interval 26.0 to 35.5 | Months | |
| Overall Survival | Sunitinib 50 mg | 29.1 | 95% Confidence Interval 25.4 to 33.1 | Months | |
| Overall Response Rate (ORR) as Assessed by Independent Review | Pazopanib 800 mg | Complete Response | 1 | Participants | |
| Overall Response Rate (ORR) as Assessed by Independent Review | Sunitinib 50 mg | Complete Response | 3 | Participants | |
| Overall Response Rate (ORR) as Assessed by Independent Review | Pazopanib 800 mg | Partial Response | 170 | Participants | |
| Overall Response Rate (ORR) as Assessed by Independent Review | Sunitinib 50 mg | Partial Response | 134 | Participants | |
| Overall Response Rate (ORR) as Assessed by Independent Review | Pazopanib 800 mg | Stable Disease | 216 | Participants | |
| Overall Response Rate (ORR) as Assessed by Independent Review | Sunitinib 50 mg | Stable Disease | 242 | Participants |
1 to 10 of 182Source ClinicalTrials.gov
See all 182 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pazopanib 800 mg | 557 | |
| Overall Study | STARTED | Sunitinib 50 mg | 553 | |
| Overall Study | Safety Population | Pazopanib 800 mg | 554 | |
| Overall Study | Safety Population | Sunitinib 50 mg | 548 | |
| Overall Study | COMPLETED | Pazopanib 800 mg | 485 | |
| Overall Study | COMPLETED | Sunitinib 50 mg | 481 | |
| Overall Study | NOT COMPLETED | Pazopanib 800 mg | 72 | |
| Overall Study | NOT COMPLETED | Sunitinib 50 mg | 72 |
Source ClinicalTrials.gov
Adverse events1,476
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pazopanib 800 mg | 36 | 554 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib 50 mg | 99 | 548 | |
| other | Anaemia | Blood and lymphatic system disorders | Pazopanib 800 mg (Post-Treatment) | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib 50 mg (Post-Treatment) | 0 | ||
| other | Leukopenia | Blood and lymphatic system disorders | Pazopanib 800 mg | 51 | 554 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib 50 mg | 100 | 548 | |
| other | Leukopenia | Blood and lymphatic system disorders | Pazopanib 800 mg (Post-Treatment) | 0 | ||
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib 50 mg (Post-Treatment) | 0 | ||
| other | Neutropenia | Blood and lymphatic system disorders | Pazopanib 800 mg | 60 | 554 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib 50 mg | 147 | 548 |
1 to 10 of 1,476Source ClinicalTrials.gov
See all 1,476 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pazopanib 800 mg | 25 | 557 |
| Total, all-cause mortality | Sunitinib 50 mg | 22 | 553 |
| Total, all-cause mortality | Pazopanib 800 mg (Post-Treatment) | 310 | 529 |
| Total, all-cause mortality | Sunitinib 50 mg (Post-Treatment) | 312 | 526 |
| Total, other adverse events | Pazopanib 800 mg | 541 | 554 |
| Total, other adverse events | Sunitinib 50 mg | 535 | 548 |
| Total, other adverse events | Pazopanib 800 mg (Post-Treatment) | 0 | 0 |
| Total, other adverse events | Sunitinib 50 mg (Post-Treatment) | 0 | 0 |
| Total, serious adverse events | Pazopanib 800 mg | 242 | 554 |
| Total, serious adverse events | Sunitinib 50 mg | 227 | 548 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00720941
GET https://conductscience.org/api/trials/v1/NCT00720941/results?page=2