Trial · NCT01147822
Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma
NCT01147822, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2013-03-15
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma. Trials, record NCT01147822. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01147822
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma
- NCT number
- NCT01147822
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 367 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Pazopanib, Sunitinib
- First posted
- 2010-06-22
- Last updated
- 2025-03-28
- Results first posted
- 2013-03-15
- 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 outcomes5
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 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941). | 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 (OS) | From randomization until date of death from any cause, assessed up to 40 months (Final OS analysis cut-off date = 30-Sep-2013) at the same time as the main study VEG108844 (NCT00720941). | Overall Survival (OS) was defined as the time (in months) from the date of randomization to the date of death due to any cause. If the patient was not known to have died, then OS was censored. The censoring date was date of the last study visit, or contact, until the cut-off date. The cut-off date was not used for last contact date, unless the patient was seen or contacted on that date. |
| Secondary | Overall Response Rate (ORR) as Assessed by Independent Review | From randomization until date of radiographic progression, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941). | Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline per central review assessment. |
| Secondary | Time to Response | From randomization until date of radiographic progression, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941). | 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, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941). | 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. |
Source ClinicalTrials.gov
Outcomes6
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 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941). | 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 (OS) | From randomization until date of death from any cause, assessed up to 40 months (Final OS analysis cut-off date = 30-Sep-2013) at the same time as the main study VEG108844 (NCT00720941). | 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, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941). | Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. | Percentage of Participants | NUMBER |
| SECONDARY | Time to Response | From randomization until date of radiographic progression, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941). | 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, assessed up to approximately 24 months (Primary analysis cut-off date = 21-May-2012) at the same time as the main study VEG108844 (NCT00720941). | 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 |
| POST_HOC | All Collected Deaths | Pre-treatment deaths: Up to 21 days prior to treatment. On-treatment deaths: Up to 125 months. Post-treatment deaths: up to 135 months. | Intent-to-Treat (ITT) Population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
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 11.1 | Months | |
| Progression-free Survival (PFS) | Sunitinib 50 mg | 11.1 | 95% Confidence Interval 8.2 to 14.3 | Months | |
| Overall Survival (OS) | Pazopanib 800 mg | 26.7 | 95% Confidence Interval 23.7 to 41.7 | Months | |
| Overall Survival (OS) | Sunitinib 50 mg | 33.4 | 95% Confidence Interval 26.9 to 39.6 | Months | |
| Overall Response Rate (ORR) as Assessed by Independent Review | Pazopanib 800 mg | 36 | 95% Confidence Interval 28.8 to 42.5 | Percentage of Participants | |
| Overall Response Rate (ORR) as Assessed by Independent Review | Sunitinib 50 mg | 21 | 95% Confidence Interval 14.7 to 26.6 | Percentage of Participants | |
| Time to Response | Pazopanib 800 mg | 11.9 | 95% Confidence Interval 6.7 to 12.3 | Weeks | |
| Time to Response | Sunitinib 50 mg | 17.9 | 95% Confidence Interval 12.0 to 23.9 | Weeks | |
| Duration of Response (DOR) | Pazopanib 800 mg | 15.2 | 95% Confidence Interval 9.9 to 17.9 | Months | |
| Duration of Response (DOR) | Sunitinib 50 mg | 18.0 | 95% Confidence Interval 12.3 to NA | Months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 | 188 | |
| Overall Study | STARTED | Sunitinib 50 mg | 179 | |
| Overall Study | Safety Population | Pazopanib 800 mg | 186 | |
| Overall Study | Safety Population | Sunitinib 50 mg | 177 | |
| Overall Study | COMPLETED | Pazopanib 800 mg | 150 | |
| Overall Study | COMPLETED | Sunitinib 50 mg | 143 | |
| Overall Study | NOT COMPLETED | Pazopanib 800 mg | 38 | |
| Overall Study | NOT COMPLETED | Sunitinib 50 mg | 36 |
Source ClinicalTrials.gov
Adverse events880
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 | 11 | 186 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib 50 mg | 50 | 177 | |
| 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 | 40 | 186 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib 50 mg | 61 | 177 | |
| 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 | Lymphopenia | Blood and lymphatic system disorders | Pazopanib 800 mg | 3 | 186 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Sunitinib 50 mg | 11 | 177 |
1 to 10 of 880Source ClinicalTrials.gov
See all 880 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pazopanib 800 mg | 7 | 188 |
| Total, all-cause mortality | Sunitinib 50 mg | 6 | 179 |
| Total, all-cause mortality | Pazopanib 800 mg (Post-Treatment) | 92 | 179 |
| Total, all-cause mortality | Sunitinib 50 mg (Post-Treatment) | 80 | 171 |
| Total, other adverse events | Pazopanib 800 mg | 182 | 186 |
| Total, other adverse events | Sunitinib 50 mg | 173 | 177 |
| 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 | 76 | 186 |
| Total, serious adverse events | Sunitinib 50 mg | 76 | 177 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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/NCT01147822
GET https://conductscience.org/api/trials/v1/NCT01147822/events?page=2